Support interventions

Support interventions

Ovarian cancer: identifying and managing familial and genetic risk

Evidence review B

NICE Guideline, No. 241

London: National Institute for Health and Care Excellence (NICE); 2024 Mar.

ISBN-13: 978-1-4731-5822-1

Interventions to support decision making about management options for women at increased risk of ovarian cancer

Review question

Which interventions are effective for supporting women at increased risk of ovarian cancer to make decisions about management options?

Introduction

Preventing inheritable ovarian cancer is a clinical priority. This can be achieved by identifying those at risk and offering them interventions that support them to make decisions that can reduce their chance of getting ovarian cancer. This is important as risk is not a straightforward concept and many ways by which we reduce an individual’s risk of ovarian cancer are not without potential harms. Therefore, those at familial risk of ovarian cancer need to be informed in a way that is meaningful to them. Healthcare systems also have to find interventions that they can deliver consistently. The aim of this review is to assess which interventions are most effective in supporting women to make decisions around their familial risk of cancer and enable them to make robust decisions as to how to best mitigate their risk.

Summary of the protocol

See Table 1 for a summary of the Population, Intervention, Comparison and Outcome (PICO) characteristics of this review.

Table 1

Summary of the protocol (PICO table).

For further details see the review protocol in appendix A.

Methods and process

This evidence review was developed using the methods and process described in Developing NICE guidelines: the manual. Methods specific to this review question are described in the review protocol in appendix A and the methods document (supplementary document 1).

Declarations of interest were recorded according to NICE’s conflicts of interest policy.

Effectiveness evidence

Included studies

Overall 16 studies were included for this review: 10 randomised controlled trials (RCTs; Armstrong 2005, Calzone 2005, Drescher 2016, Green 2004, Lerman 1997, Roussi 2010, Schwartz 2014, Tiller 2006, Vogel 2019, Wang 2005) and 6 cluster RCTs (Kinney 2014, Manchanda 2016, van Roosmalen 2004a, van Roosmalen 2004b, Wakefield 2008a, Wakefield 2008b).

In 5 of the cluster randomised trials the unit of clustering was the family and the cluster-size was small ranging from 1.02 to 1.16 (Kinney 2014, van Roosmalen 2004a, van Roosmalen 2004b, Wakefield 2008a, Wakefield 2008b). In Manchanda 2016 clustering was by clinic with an average cluster size of 3.8.

Two studies compared genetic counselling with usual care (Lerman 1997, Drescher 2016).

Seven studies looked at augmenting genetic counselling with some form of decision support intervention (Green 2004, Tiller 2006, van Roosmalen 2004a, Roussi 2010, Wakefield 2004a, Wakefield 2004b, Wang 2005).

Two studies compared telephone with in-person genetic counselling (Kinney 2014, Schwartz 2014).

Two studies examined whether a group education session before individual genetic counselling could reduce the time needed for the individual session (Calzone 2005, Manchanda 2016).

Two studies compared decision support interventions with usual care in women who were BRCA1/2 mutation carriers (Armstrong 2005, van Roosmalen 2004b).

One study looked at an educational mobile app about genetic counselling for women with ovarian cancer (Vogel 2019).

Some of the studies included not only women but also men (Calzone 2005 5.6% in the group counselling and 4.2% in the individual counselling; Manchanda 2016: 35% men in the DVD + group counselling and 32% men in the group counselling). Whilst the population in the protocol is women, the committee agreed that these percentages of men are acceptable.

The included studies are summarised in Table 2.

See the literature search strategy in appendix B and study selection flow chart in appendix C.

Excluded studies

Studies not included in this review are listed, and reasons for their exclusion are provided in appendix K.

Summary of included studies

Summaries of the studies that were included in this review are presented in Table 2.

Table 2

Summary of included studies.

See the full evidence tables in appendix D and the forest plots in appendix E.

Summary of the evidence

Studies reported a variety of approaches to providing information and support for individuals to make decisions regarding genetic testing uptake and management options to reduce their risk of ovarian cancer.

Genetic counselling versus usual care

Moderate quality evidence showed an important benefit of genetic counselling in terms of the uptake of genetic testing in those who were at potentially high risk of familial ovarian cancer. However, very low quality evidence showed no important difference for the same outcome between genetic counselling and usual care in those with low to moderate risk of cancer.

Low quality evidence showed an important benefit of genetic counselling in terms of the uptake of risk reducing surgery and better decision quality with genetic counselling as compared to usual care.

Genetic counselling plus decision support intervention versus genetic counselling alone

In terms of decision quality, low quality evidence indicated an important benefit of decision support interventions used as an adjunct to genetic counselling when compared to genetic counselling alone. Moderate to high quality evidence showed an important benefit of decision support interventions used as an adjunct to genetic counselling in terms of increased satisfaction with the decision aid as well as a lowered likelihood of women choosing ovarian cancer screening as their treatment. However, moderate to high evidence also showed no important difference in terms of other outcomes (for example, resolution of decision needs, adverse effects) between the 2 groups.

Telephone genetic counselling versus in-person genetic counselling

Very low to high quality evidence showed no important difference between telephone genetic counselling and in-person genetic counselling for outcomes such as resolution of decision needs, adverse effects, the uptake of genetic testing, satisfaction with the intervention and decision quality.

Group education session followed by individual genetic counselling versus individual education and genetic counselling

Low to high quality evidence indicated that a group education session (or DVD) preceding a shorter individual genetic counselling session was not inferior to individual education and counselling. Time taken for individual counselling, however, was not an outcome analysed in this evidence review.

Decision support versus usual care in BRCA1/2 mutation carriers

In terms of adverse effects such as anxiety, depression and cancer worry, High quality evidence showed no important difference between decision aids when compared to usual care for women who are BRCA1/2 positive. However, moderate quality evidence showed better decision satisfaction with the decision aid.

Education app versus usual care (pre genetic counselling)

Moderate quality evidence from a single trial evaluating a mobile telephone app for educating women with ovarian cancer about genetic counselling showed no evidence of an important difference in terms of an increased uptake of counselling with use of the app. However, high quality evidence showed an important benefit of the app in terms of improved decision quality when compared to usual care.

See appendix F for full GRADE tables.

Economic evidence

Included studies

Two economic studies were identified which were relevant to this review (Manchanda 2016, Tutty 2019).

A single economic search was undertaken for all topics included in the scope of this guideline. See supplementary material 2 for details.

Excluded studies

Economic studies not included in this review are listed and reasons for their exclusion are provided in Supplement 2.

Summary of included economic evidence

The systematic search of the economic literature undertaken for the guideline identified the following studies:

DVD-assisted genetic counselling for BRCA1/2

One UK study on the cost-minimisation of DVD-assisted genetic counselling for BRCA1/2 in adult Ashkenazi-Jewish men and women (Manchanda 2016).

Telephone pre- and post-test genetic counselling for BRCA1/2

One Australian study on the costs of telephone pre- and post-test genetic counselling for BRCA1/2 in adult women with high-grade serous ovarian cancer (Tutty 2019).

See the economic evidence tables in appendix H. See Table 3 to Table 4 for the economic evidence profiles of the included studies.

Table 3

Economic evidence profile for DVD-assisted genetic counselling (DVD-C) for BRCA1/2 versus traditional face-to-face counselling (TC) only for BRCA1/2.

Table 4

Economic evidence profiles for telephone pre- and post-test genetic counselling (TC) for BRCA1/2 versus in-person pre- and post-test genetic counselling (SC) for BRCA1/2.

Economic model

No economic modelling was undertaken for this review because the committee agreed that other topics were higher priorities for economic evaluation.

Evidence statements

Economic

DVD-assisted genetic counselling for BRCA1/2

Evidence from a cost-minimisation analysis conducted alongside a non-inferiority RCT (Manchanda 2016, N=936) suggests that DVD-assisted genetic counselling (DVD-C) for BRCA1/2 is likely to be preferred to traditional face-to-face counselling (TC) for BRCA1/2 alone in the general adult Ashkenazi-Jewish population (men and women) in the UK. DVD-C was non-inferior to TC for genetic testing uptake, change in cancer risk perception, increase in knowledge, counselling time and satisfaction and less costly than TC. The study is partially applicable to the NICE decision-making context and has minor limitations.

Telephone pre- and post-genetic counselling for BRCA1/2

Evidence from a cost analysis (Tutty 2019) with costs from a case-control study (N=120) suggests that telephone pre- and post-genetic counselling is cost-saving compared with traditional face-to-face counselling in adult women with high-grade serous ovarian cancer. The study is partially applicable to the NICE decision-making context and has potentially serious limitations.

The committee’s discussion and interpretation of the evidence

The outcomes that matter most

Preparation for active participation in making a health decision was a critical outcome because it reflects whether the interventions help increase people’s confidence in making decisions about their own healthcare. Resolution of decisional needs was also a critical outcome because it indicates whether an intervention helps resolve the key uncertainties and conflicts that prevent people from making a healthcare decision. Adverse effects associated with decision making, both at the time of making the decision and afterwards, were the final critical outcomes. Decision regret, anxiety, depression, distress, grief or loss and cancer worry were identified as examples of such adverse effects.

Satisfaction with the decision support intervention was an important outcome as it reflects the acceptability of the intervention. Uptake of the management option being considered was also chosen as an important outcome because it indicates whether the intervention influenced decisions one way or another (increasing or decreasing the proportion of people choosing that option). Decision quality was an important outcome as it reflects whether people are making fully informed decisions based on a good understanding of the options. Quality of life was an important outcome too because it indicates whether interventions that support decision making have an overall impact on the person’s life.

The quality of the evidence

The quality of the evidence was assessed using GRADE and ranged from low to high, with most of the evidence being of moderate quality. Evidence was downgraded predominately due to risk of bias, imprecision, and inconsistency. There was no relevant evidence identified for psychological support interventions and for some adverse effects related to decision making, such as distress, grief or loss and quality-of-life outcomes.

Benefits and harms

The committee reflected on the variety of approaches used to provide information and support for individuals preparing to make a healthcare decision related to genetic testing and management options to reduce their risk of ovarian cancer. They also noted that studies included various populations (for example, women with known BRCA1/2 mutations, those with a personal or family history of breast or ovarian, women diagnosed with epithelial ovarian, primary peritoneal or fallopian tube cancer) and the differing follow-up periods (for example, 1 week and 2 years). They also noted that 2 studies included a small proportion of men. Despite these limitations the committee decided to use the evidence as well as their experience and expertise to draft recommendations.

The committee recommended that healthcare professionals in genetics services should provide ongoing information and support. The committee found that important because, according to the evidence report A which focuses on information and support, the majority of the evidence suggests that people generally thought that they did not receive all the information and support they hoped to receive.

Evidence indicated that, compared with usual care, genetic counselling was associated with a higher uptake of the options being considered (such as the uptake of genetic testing and risk-reducing surgery in those at potentially high risk of familial ovarian cancer) and better knowledge about ovarian cancer risk (enabling more informed decision making). The committee discussed that this evidence was low to moderate quality, but noted that this finding was consistent with their experience and they considered genetic counselling to be an essential component of care. So they decided that individuals who meet the criteria for genetic testing should be provided with information about referral for genetic counselling and testing. They agreed that during genetic counselling information would always be shared with the person that would aim to help decision-making. The committee noted that this should include topics such as genetic testing, risk-reducing surgery, fertility and whether the person wants to have children, and menopause and managing symptoms genetic testing, risk-reducing surgery, fertility and whether the person wants to have children, and menopause and managing symptoms. This would allow the person to make a fully informed decision.

Based on their experience, the committee recommended that a healthcare professional with skills and experience in information provision and shared decision making specifically related to genetics and cancer risk should offer genetic counselling to people who meet the referral criteria for genetic testing. They acknowledged that this professional may not always be a genetic counsellor because genetic counselling services are being integrated into routine healthcare settings. This means that oncologists or nurse specialists may also counsel a woman about the option of genetic testing. The committee agreed that the professional’s experience in information provision and shared decision making in the context of genetics and cancer risk was vital to help the person to make informed decisions.

The committee discussed that, although very low to high quality evidence showed no important difference in outcomes with telephone and face-to-face genetic counselling, based on their experience of remote consultations since the COVID-19 pandemic, they recognised that this was now a far more common method of delivery and decided to recommend face-to-face or remote genetic counselling. They noted that there were factors to take into account when deciding whether a remote or a face-to-face consultation would be more appropriate. For example, they agreed that personal preferences should be considered because this could influence how engaged someone is in the process and how much information they take in. It was also discussed that there were many different types of decisions that will have to be made at different times and that some discussions were potentially more appropriate face-to-face than remote (for example, they discussed that risk-reducing surgery would better be discussed in face-to-face meetings but did not want to be prescriptive about this). They noted that remote counselling could have some advantages related to access to services (for example, people living in rural areas) but potentially some disadvantages for people with language or communication needs or people who do not have digital access. There are other factors that should be taken into account, such as when people do not understand or speak English and a translator is required. For these people face-to-face counselling may be preferable so that a translators can facilitate consultations.

There was some evidence to support group information giving sessions, for example by watching an informational DVD as a group. The committee noted that this evidence was mostly of high quality and recommended group sessions as an efficient way to deliver generic information before the person receives an individual genetic counselling session tailored to their personal information and support needs. However, they agreed that in some circumstances providing information on an individual basis may still be preferable, so they recommended group sessions be considered. Despite the potential cost savings, the committee did not want to be prescriptive about this because circumstances can vary widely (for example, level of risk, level of distress or other factors such as communication or language difficulties), which may mean that an individual session may be preferable for some people.

There was some moderate quality evidence to support the use of decision aids as an adjunct to genetic counselling in the context of breast and ovarian cancer risk management for people with pathogenic variants associated with increased ovarian cancer risk. The committee noted that none of the studies provided sufficient detail to reuse the patient decision aids and some are not publicly available, however they agreed that the concept of a decision aid may be considered as an option to support decision making. The committee decided against recommending specific decision aids, due to concerns about their need to be kept up-to-date and requirements for validation.

The committee noted a lack of relevant evidence on psychological interventions to support decision making They thought that psychological support could play an important role in helping women to make informed decisions at a time of anxiety and distress and therefore agreed to make a research recommendation on the effectiveness of psychological interventions.

Cost effectiveness and resource use

The committee discussed that it is current practice to offer genetic counselling to people at high risk of familial ovarian cancer. They acknowledged that the potential widening of the eligibility criteria for genetic counselling might have implementation issues due to a need for more trained individuals to undertake genetic counselling. However, the committee explained that genetic counselling services are increasingly being integrated into routine healthcare settings. This integration enables not only genetic counsellors but also oncologists or nurse specialists to provide counselling regarding genetic testing.

There was one existing economic study on genetic testing models. It suggested that telephone genetic counselling was cost saving for BRCA1/2 compared with in-person genetic counselling. The committee acknowledged that this evidence was non-UK and that this study partially applied to the NICE decision-making context and had potentially serious limitations. The committee noted that video rather than telephone delivery is the current practice for most services. This may impact outcomes and further limit the applicability of this evidence. For example, a video session may result in better engagement than a telephone session. The committee also noted that this study had short time horizon which may not be long enough to capture all important differences in costs. For example, people who are at risk of familial ovarian cancer are going through a lifelong journey and may have multiple consultations before deciding whether to have, for example, genetic testing. This may mean that this study may have underestimated costs. It also has not considered effectiveness outcomes.

The committee also noted that the telephone model also provided an opportunity to access hard-to-reach populations. For example, individuals residing in rural areas who may face barriers in accessing in-person counselling services. The economic analysis did not consider such potential benefits of the telephone counselling approach. Overall the committee agreed that the telephone and in-person genetic counselling models were broadly similar.

The committee also discussed the possibility that telephone genetic counselling might be much more acceptable. For example, it may reduce travel costs and allow a person’s family to be present during a digital consultation. This is generally not possible during an in-person consultation.

The committee explained that services currently use both video and in-person genetic counselling models. The recommendations in this area are not expected to represent a change in practice or require additional resources to implement.

The committee explained that group sessions which occur before an individual genetic counselling session where people get general information are not current practice. However, such models utilising group sessions are not inferior in terms of clinical outcomes. They result in shorter individual genetic counselling sessions and potential cost savings for the NHS. One supporting UK study suggested that DVD-assisted genetic counselling for small groups of people with BRCA variant resulted in reduced costs and non-inferior outcomes compared with traditional individual in-person counselling.

The committee noted that this evidence was only partially applicable to the review due to a sample comprising a large proportion of men. Nevertheless, the committee was of the view that the findings were encouraging and supported alternative genetic counselling models. The committee also noted that people might value mutual support from such group sessions and that such benefits have not been accounted for in the economic evaluation. The committee explained that since this is not current practice, their recommendation may require some service re-organisation. However, there is potential for further savings due to shorter individual genetic counselling sessions. Given the lack of suitably trained staff to deliver genetic counselling some capacity may also be created in the system and help address broader workforce shortages.

Overall, due to the broadening of genetic testing criteria, more people may be accessing support services, which could result in increased pressure on existing services. However, access to support services such as genetic counselling and psychological services is essential for decision-making and risk management uptake. Successful risk management will lead to fewer cancers and associated cost savings to services, outweighing any additional costs associated with investment in capacity within these services.

Other factors the committee took into account

The committee noted that genetic tests are now commercially available (known as direct-to-consumer testing) and discussed what would happen if a person accesses NHS services and presents with a positive genetic test result. They agreed that not all laboratories produce accurate test results or prepare people for their test results; therefore, positive test results for a pathogenic variant for which NHS testing is offered will need to be discussed with an NHS genetics service to decide if referral is needed. This is consistent with the joint guidance by the Royal College of GPs and the British Society for Genetic Medicine.

The committee explained that many services do not accept referrals from individuals who have undergone direct-to-consumer genomic testing primarily because of the unreliability of such tests. This direct-to-consumer testing leads to the unnecessary burden of confirming non-existent variants. The recommendation in this area may help to address this issue by ensuring that only appropriate cases with reliable results are referred to genetic services. This is consistent with other guidance and should be current practice for most services.

The committee were aware of other relevant guidance and made cross reference to it: the NICE guideline on shared decision making and the recommendations on patient decision aids in the NICE guideline on shared decision making.

Recommendations supported by this evidence review

This evidence review supports recommendations 1.2.7 to 1.2.11 as well as 1.3.2 and bullet 8 in Table 1 and bullet 6 in Table 2 and research recommendation 1 on psychological support interventions in the NICE guideline.

References – included studies

Effectiveness

Armstrong 2005
Armstrong, K., Weber, B., Ubel, P. A. et al. Individualized survival curves improve satisfaction with cancer risk management decisions in women with BRCA1/2 mutations. Journal of Clinical Oncology 23(36): 9319–28, 2005 [PubMed: 16361631]
Calzone 2005
Calzone, K. A., Prindiville, S. A., Jourkiv, O. et al. Randomized comparison of group versus individual genetic education and counselling for familial breast and/or ovarian cancer. Journal of Clinical Oncology 23(15): 3455–64, 2005 [PubMed: 15908654]
Drescher 2016
Drescher, C. W., Beatty, J. D., Resta, R. et al. The effect of referral for genetic counselling on genetic testing and surgical prevention in women at high risk for ovarian cancer: Results from a randomized controlled trial. Cancer 122(22): 3509–3518, 2016 [PMC free article: PMC5253334] [PubMed: 27447168]
Green 2004
Green, M. J., Peterson, S. K., Baker, M. W. et al. Effect of a computer-based decision aid on knowledge, perceptions, and intentions about genetic testing for breast cancer susceptibility: a randomized controlled trial. JAMA 292(4): 442–52, 2004 [PMC free article: PMC1237120] [PubMed: 15280342]
Kinney 2014
Kinney, A. Y., Butler, K. M., Schwartz, M. D. et al. Expanding access to BRCA1/2 genetic counselling with telephone delivery: a cluster randomized trial. Journal of the National Cancer Institute 106(12), 2014 [PMC free article: PMC4334799] [PubMed: 25376862]
Lerman 1997
Lerman, C., Biesecker, B., Benkendorf, J. L. et al. Controlled trial of pretest education approaches to enhance informed decision-making for BRCA1 gene testing. Journal of the National Cancer Institute 89(2): 148–57, 1997 [PubMed: 8998184]
Manchanda 2016
Manchanda, R., Burnell, M., Loggenberg, K. et al. Cluster-randomised non-inferiority trial comparing DVD-assisted and traditional genetic counselling in systematic population testing for BRCA1/2 mutations. J Med Genet 53(7): 472–80, 2016 [PubMed: 26993268]
Roussi 2010
Roussi, P., Sherman, K. A., Miller, S. et al. Enhanced counselling for women undergoing BRCA1/2 testing: Impact on knowledge and psychological distress-results from a randomised clinical trial. Psychology & Health 25(4): 401–15, 2010 [PMC free article: PMC2866521] [PubMed: 20204945]
Schwartz 2014
Schwartz, M. D., Valdimarsdottir, H. B., Peshkin, B. N. et al. Randomized noninferiority trial of telephone versus in-person genetic counselling for hereditary breast and ovarian cancer. Journal of Clinical Oncology 32(7): 618–26, 2014 [PMC free article: PMC3927731] [PubMed: 24449235]
Tiller 2006
Tiller, K., Meiser, B., Gaff, C. et al. A randomized controlled trial of a decision aid for women at increased risk of ovarian cancer. Medical Decision Making 26(4): 360–72, 2006 [PubMed: 16855125]
van Roosmalen 2004a
van Roosmalen, M. S., Stalmeier, P. F., Verhoef, L. C. et al. Randomised trial of a decision aid and its timing for women being tested for a BRCA1/2 mutation. British Journal of Cancer 90(2): 333–42, 2004 [PMC free article: PMC2410151] [PubMed: 14735173]
van Roosmalen 2004b
van Roosmalen, M. S., Stalmeier, P. F., Verhoef, L. C. et al. Randomized trial of a shared decision-making intervention consisting of trade-offs and individualized treatment information for BRCA1/2 mutation carriers. Journal of Clinical Oncology 22(16): 3293–301, 2004 [PubMed: 15310772]
Vogel 2019
Vogel, R. I., Niendorf, K., Petzel, S. et al. A patient-centered mobile health application to motivate use of genetic counselling among women with ovarian cancer: A pilot randomized controlled trial. Gynecol Oncol 153(1): 100–107, 2019 [PubMed: 30718125]
Wakefield 2008a
Wakefield, C. E., Meiser, B., Homewood, J. et al. A randomized controlled trial of a decision aid for women considering genetic testing for breast and ovarian cancer risk. Breast Cancer Research & Treatment 107(2): 289–301, 2008 [PubMed: 17333332]
Wakefield 2008b
Wakefield, C. E., Meiser, B., Homewood, J. et al. A randomized trial of a breast/ovarian cancer genetic testing decision aid used as a communication aid during genetic counselling. Psycho-Oncology 17(8): 844–54, 2008 [PubMed: 18613319]
Wang 2005
Wang, C., Gonzalez, R., Milliron, K. J. et al. Genetic counselling for BRCA1/2: a randomized controlled trial of two strategies to facilitate the education and counselling process. American Journal of Medical Genetics. Part A 134a(1): 66–73, 2005 [PubMed: 15690408]

Economic

Manchanda 2016
Manchanda R, Burnell M, Loggenberg K, Desai R, Wardle J, Sanderson SC, Gessler S, Side L, Balogun N, Kumar A, Dorkins H., Cluster-randomised non-inferiority trial comparing DVD-assisted and traditional genetic counselling in systematic population testing for BRCA1/2 mutations. Journal of medical genetics, 53, 472–80, 2016 [PubMed: 26993268]
Tutty 2019
Tutty E, Petelin L, McKinley J, Young MA, Meiser B, Rasmussen VM, Forbes Shepherd R, James PA, Forrest LE., Evaluation of telephone genetic counselling to facilitate germline BRCA1/2 testing in women with high-grade serous ovarian cancer, European Journal of Human Genetics, 27, 1186–96, 2019 [PMC free article: PMC6777607] [PubMed: 30962500]

Appendices

Appendix G. Economic evidence study selection

Study selection for: Which interventions are effective for supporting women at increased risk of ovarian cancer to make decisions about management options?

One global search was undertaken – please see Supplement 2 for details on study selection.

Appendix H. Economic evidence tables

Economic evidence tables for review question: Which interventions are effective for supporting women at increased risk of ovarian cancer to make decisions about management options? (PDF, 198K)

Appendix I. Economic model

Economic model for review question: Which interventions are effective for supporting women at increased risk of ovarian cancer to make decisions about management options?

No economic analysis was conducted for this review question.

Appendix J. Excluded studies

Excluded studies for review question: Which interventions are effective for supporting women at increased risk of ovarian cancer to make decisions about management options?

Excluded effectiveness studies

Table 15

Excluded studies and reasons for their exclusion.

Excluded economic studies

See Supplement 2 for the list of excluded studies across all reviews.

Appendix K. Research recommendations – full details

Research recommendations for review question: Which interventions are effective for supporting women at increased risk of ovarian cancer to make decisions about management options?

K.1. Research recommendation

What is the effectiveness of psychological interventions to support decision making for people who meet the referral criteria for genetic testing?

K.1.1. Why this is important (PDF, 155K)

Final

Evidence reviews underpinning recommendations 1.2.7 to 1.2.11, 1.3.2, as well as bullet 8 in table 1, bullet 6 in table 2 and research recommendation 1 in the NICE guideline

These evidence reviews were developed by NICE

Disclaimer: The recommendations in this guideline represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals are expected to take this guideline fully into account, alongside the individual needs, preferences and values of their patients or service users. The recommendations in this guideline are not mandatory and the guideline does not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or their carer or guardian.

Local commissioners and/or providers have a responsibility to enable the guideline to be applied when individual health professionals and their patients or service users wish to use it. They should do so in the context of local and national priorities for funding and developing services, and in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Nothing in this guideline should be interpreted in a way that would be inconsistent with compliance with those duties.

NICE guidelines cover health and care in England. Decisions on how they apply in other UK countries are made by ministers in the Welsh Government, Scottish Government, and Northern Ireland Executive. All NICE guidance is subject to regular review and may be updated or withdrawn.

Bookshelf ID: NBK604386PMID: 38896769

Table 1Summary of the protocol (PICO table)

Population	Women with familial ovarian cancer or at increased risk of ovarian cancer preparing to make a healthcare decision
Intervention	Decision coaching for decision making such as: Health counselling (including genetic counselling) Psychological support Evidence based information (including online tools) such as: Decision aids Combination of decision coaching and evidence-based information
Comparison	Interventions compared with each other Usual care (no formal method used to help with decision making)
Outcomes	Critical Preparation for active participation in making an informed health decision Resolution of decisional needs Adverse effects (during or after decision making) such as: Decision regret Anxiety Depression Distress Grief or loss Cancer worry Important Satisfaction with decision support intervention Uptake of the management option being considered Decision quality Quality of life

Table 2Summary of included studies

Study	Population	Intervention	Comparison	Outcomes
Armstrong 2005 RCT USA	N=27 women who underwent BRCA1/2 testing Age (mean [range], years): intervention 45 [30-59]; control 42 [26-54]	Decision support intervention (personalised survival and cancer incidence data associated with cancer management options)	Usual care (educational booklet)	Decision satisfaction score
Calzone 2005 RCT USA	N=142 individuals with known BRCA1/2 mutation Age, years: intervention 40; control 41	Group education + brief individual counselling	Individual education + counselling	Adverse effects: cancer worry Decision quality: objective knowledge Uptake of the option being considered: rate of genetic testing
Drescher 2016 RCT USA	N=458 women identified from a mammography database; they had to meet the NCCN 2013 pedigree criteria for referral to a genetic counsellor Age, mean (SD), years: intervention 54 (10) years; control 53 (10)	Genetic counselling	Usual care	Uptake of the option being considered: rate of genetic testing and bilateral salpingo-oophorectomy
Green 2004 RCT USA	N=211 women referred for genetic counselling for evaluation of personal or family history of breast cancer Age, mean (SD not reported), years: intervention 45; control 44	Computer education followed by genetic counselling	Genetic counselling	Decision quality: objective knowledge test Adverse effects: anxiety Uptake of the option being considered: genetic testing
Kinney 2014 Cluster RCT USA	N=998 family clusters (1012 women with personal or family histories of breast or ovarian cancer Age, mean years: 56.1 (SD 8.2)	Telephone genetic counselling	In person genetic counselling	Adverse effects: anxiety Adverse effects: cancer worry Adverse effects: decision regret Decision quality: objective knowledge test Resolution of decisional needs: decisional conflict scale, range Uptake of the option being considered: genetic testing rate
Lerman 1997 RCT USA	N=400 women who had at least one first-degree relative with breast and/or ovarian cancer Age, years: >50: education 30%; education + counselling 25%, control 30%	Education Education + counselling	Waiting list control	Uptake of the option being considered: intention to get BRCA1 test Decision quality: objective knowledge scale
Manchanda 2016 Cluster RCT UK	N=256 clusters (936 Ashkenazi Jewish ethnicity individuals) Age, mean (SD), years: intervention 53.9 (14.9), control 53.9 (15.1)	Group DVD + genetic counselling	Genetic counselling	Uptake of the option being considered: genetic testing Satisfaction with intervention: counselling Decision quality: objective knowledge
Roussi 2010 RCT USA	N=134 women who contacted a family risk assessment program and had a family history consistent with possible hereditary breast and/or ovarian cancer Age, years: 47% aged over 50	Enhanced genetic counselling	Standard genetic counselling	Decision quality: objective knowledge
Schwartz 2014 RCT USA	N=669 women with a minimum 10% risk for a BRCA1/2 mutation Age, mean (SD), years: intervention 47.7 (13.1); control 48.4 (14.2)	Telephone genetic counselling	In person genetic counselling	Resolution of decisional needs: decisional conflict scale Adverse effects: cancer worry Uptake of the option being considered: rate of genetic testing Satisfaction with decision support intervention
Tiller 2006 RCT Australia	N=131 women from high-risk families Age, mean, years: intervention 45.8; control 46.3	Decision aid + genetic counselling	genetic counselling	Decision quality: objective knowledge Adverse effects: anxiety Adverse effects: depression Resolution of decisional needs: decisional conflict scale Uptake of the option being considered: rates of risk reducing surgery
van Roosmalen 2004a Cluster RCT the Netherlands	N=368 women at increased risk of carrying a pathogenic variant Age mean (SD), years: intervention 43.7 (11.3); control43.5 (10.4)	Decision aid + genetic counselling	genetic counselling	Adverse effects: anxiety Adverse effects: depression Adverse effects: cancer worry Resolution of decisional needs: decision conflict scale Satisfaction with decision support intervention Uptake of the option being considered: treatment choice prophylactic oophorectomy Uptake of the option being considered: treatment choice ovarian cancer screening Uptake of the option being considered: treatment choice undecided
van Roosmalen 2004b Cluster RCT The Netherlands	N=88 women affected and unaffected with breast/ovarian cancer who had chosen to undergo DNA testing Age mean (SD), years: intervention 39.1 (9.7): control 39.9 (10.4)	Decision support intervention	Usual care	Adverse effects: anxiety Adverse effects: depression Adverse effects: cancer worry
Vogel 2019 RCT USA	N=104 women with a diagnosis of epithelial ovarian, primary peritoneal or fallopian tube cancer who had not previously received or scheduled genetic counselling or testing related to cancer Age, mean (SD), years: intervention 60.9 (10.7); control 62 (12.0)	Mobile educational app for genetic information on cancer (mAGIC)	Usual care	Uptake of the option being considered: rate of genetic counselling Decision quality: objective knowledge test
Wakefield 2008a Cluster RCT Australia	N=145 women with a family history consistent with a dominantly inherited hereditary breast/ovarian cancer syndrome who have an affected, living relative willing to provide a blood sample Age, mean, years: intervention 45.8; control 49.6	Decision aid + genetic counselling	Genetic counselling	Resolution of decisional needs: decisional conflict scale Decision quality: objective knowledge Uptake of the option being considered: rate of genetic tests
Wakefield 2008b Cluster RCT Australia	N=123 women who contacted a familial cancer clinic and were eligible for genetic testing Age, mean, years: intervention 49.2; control 48.2	Decision aid + genetic counselling	Genetic counselling	Resolution of decisional needs: decisional conflict scale Decision quality: objective knowledge Uptake of the option being considered: rate of genetic tests
Wang 2005 RCT USA	N=198 women attending the Breast and Ovarian Cancer Risk Evaluation Program Age, mean, years: 44-45	4 trial arms CD-ROM + Genetic counselling Feedback + Genetic counselling CD-ROM+ Feedback + Genetic counselling	Genetic counselling	Uptake of the option being considered: rate of genetic testing

: CD-ROM: compact disc read only memory; NCCN: National Comprehensive Cancer Network; SD: standard deviation: RCT: randomised controlled trial

Table 3Economic evidence profile for DVD-assisted genetic counselling (DVD-C) for BRCA1/2 versus traditional face-to-face counselling (TC) only for BRCA1/2

Study

Limitations

Applicability

Other comments

Incremental

Uncertainty

Costs

Effect

Cost effectiveness

Manchanda 2016

Cost-minimisation analysis

Minor ^[1]

Partially ^[2]

A cluster-randomised non-inferiority RCT (N=936), [Manchanda 2016]

Time horizon: Under 1 year

Outcome: Genetic testing uptake, change in cancer risk perception, increase in knowledge, counselling time, satisfaction

−£14

DVD-C non-inferior to TC for increase in knowledge, counselling satisfaction, and change in risk perception.

DVD-C equivalent to TC for genetic testing uptake.

DVD-C preferred

-: No significant differences in outcomes.

-: Adjusting knowledge scores to account for the proportion of valid questions answered and missing answers and transforming Genetic Counselling Satisfaction Scores to account for skewness did not change the results.

-: Using multiple imputation for missing data showed similar results.

: Abbreviations: DVD-C: DVD assisted genetic counselling; N: number of people; RCT: Randomised controlled trial; TC: Traditional face-to-face counselling; UK: United Kingdom

[1]: Time horizon (under one year), however, there is no difference in outcomes and extending the time horizon is unlikely to change the result; effectiveness from a single RCT (N=936), the baseline estimates are unlikely to reflect outcomes for people in the UK, as these were based on a single RCT

[2]: UK study; substantial proportion were males; no quality-adjusted life-years (QALYs), however not a problem since equivalent outcomes, superior genetic testing uptake, and lower costs

Table 4Economic evidence profiles for telephone pre- and post-test genetic counselling (TC) for BRCA1/2 versus in-person pre- and post-test genetic counselling (SC) for BRCA1/2

Study

Limitations

Applicability

Other comments

Incremental

Uncertainty

Costs ^[1]

Effect

Cost effectiveness

Tutty 2019

Australia

Cost-analysis

Potentially serious ^[2]

Partially ^[3]

Time horizon: 1 year

Outcome: Cost savings

−£8

TC cost saving

: Abbreviations: NA: Not applicable; NR: Not reported; TC: Telephone genetic counselling

[1]: Costs were converted to UK pounds using OECD purchasing power parities (PPPs)

[2]: No statistical analysis on costs, costs from a case-control study (N=120)

[3]: The non-UK study, has not considered comparative health outcomes

Table 15Excluded studies and reasons for their exclusion

Study	Reason for exclusion
Banegas, Matthew Patrick (2013) Prediction, communication, and distribution of breast cancer risk. Dissertation Abstracts International: Section B: The Sciences and Engineering 73(12be)	Study design not relevant to this review protocol
Baroutsou, V., Underhill-Blazey, M. L., Appenzeller-Herzog, C. et al. (2021) Interventions Facilitating Family Communication of Genetic Testing Results and Cascade Screening in Hereditary Breast/Ovarian Cancer or Lynch Syndrome: A Systematic Review and Meta-Analysis. Cancers 13(4): 23 [PMC free article: PMC7926393] [PubMed: 33672149]	Systematic review used as source of primary studies
Brain, K., Gray, J., Norman, P. et al. (2000) Randomized trial of a specialist genetic assessment service for familial breast cancer. J Natl Cancer Inst 92(16): 1345–51 [PubMed: 10944557]	Intervention in study does not match that specified in this review protocol
Brain, K., Norman, P., Gray, J. et al. (2002) A randomized trial of specialist genetic assessment: psychological impact on women at different levels of familial breast cancer risk. British Journal of Cancer 86(2): 233–8 [PMC free article: PMC2375197] [PubMed: 11870512]	Intervention in study does not match that specified in this review protocol
Braithwaite, D., Emery, J., Walter, F. et al. (2004) Psychological impact of genetic counselling for familial cancer: A systematic review and meta-analysis. Journal of the National Cancer Institute 96(2): 122–133 [PubMed: 14734702]	Systematic review used as source of primary studies
Butrick, M., Kelly, S., Peshkin, B. N. et al. (2015) Disparities in uptake of BRCA1/2 genetic testing in a randomized trial of telephone counselling. Genet Med 17(6): 467–75 [PMC free article: PMC4364924] [PubMed: 25232856]	Post-hoc analysis of Schwartz 2014 trial
Fournier, D. M.; Bazzell, A. F.; Dains, J. E. (2018) Comparing Outcomes of Genetic Counselling Options in Breast and Ovarian Cancer: An Integrative Review. Oncology Nursing Forum 45(1): 96–105 [PubMed: 29251290]	Systematic review used as source of primary studies
Gao, J. P., Jin, Y. H., Yu, S. F. et al. (2020) Evaluate the effectiveness of breast cancer decision aids: A systematic review and meta-analysis of randomize clinical trails. Nursing open [PMC free article: PMC8363361] [PubMed: 33377613]	Systematic review used as source of primary studies
Gray, S. W., O’Grady, C., Karp, L. et al. (2009) Risk information exposure and direct-to-consumer genetic testing for BRCA mutations among women with a personal or family history of breast or ovarian cancer. Cancer Epidemiology, Biomarkers & Prevention 18(4): 1303–11 [PMC free article: PMC2963112] [PubMed: 19318436]	Population not relevant to this review protocol
Green, M. J., McInerney, A. M., Biesecker, B. B. et al. (2001) Education about genetic testing for breast cancer susceptibility: patient preferences for a computer program or genetic counselor. American Journal of Medical Genetics 103(1): 24–31 [PubMed: 11562930]	Comparator in study does not match that specified in this review protocol
Grimmett, C., Pickett, K., Shepherd, J. et al. (2018) Systematic review of the empirical investigation of resources to support decision-making regarding BRCA1 and BRCA2 genetic testing in women with breast cancer. Patient Education & Counselling 101(5): 779–788 [PubMed: 29225062]	Systematic review used as source of primary studies
Halbert, C. H., Wenzel, L., Lerman, C. et al. (2004) Predictors of participation in psychosocial telephone counselling following genetic testing for BRCA1 and BRCA2 mutations. Cancer Epidemiology, Biomarkers & Prevention 13(5): 875–81 [PubMed: 15159322]	Comparator in study does not match that specified in this review protocol
Helmes, A. W.; Culver, J. O.; Bowen, D. J. (2006) Results of a randomized study of telephone versus in-person breast cancer risk counselling. Patient Education & Counselling 64(13): 96–103 [PubMed: 16427245]	Population not relevant to this review protocol
Hilgart, J. S.; Coles, B.; Iredale, R. (2012) Cancer genetic risk assessment for individuals at risk of familial breast cancer. Cochrane Database of Systematic Reviews [PMC free article: PMC7154385] [PubMed: 22336791]	Systematic review used as source of primary studies
Hooker, G. W., Leventhal, K. G., DeMarco, T. et al. (2011) Longitudinal changes in patient distress following interactive decision aid use among BRCA1/2 carriers: a randomized trial. Medical Decision Making 31(3): 412–21 [PMC free article: PMC3935602] [PubMed: 20876346]	No relevant data reported
Howard, A. F.; Balneaves, L. G.; Bottorff, J. L. (2009) Women’s decision making about risk-reducing strategies in the context of hereditary breast and ovarian cancer: A systematic review. Journal of Genetic Counselling 18(6): 578–597 [PubMed: 19802692]	Systematic review used as source of primary studies
Interrante, M. K., Segal, H., Peshkin, B. N. et al. (2017) Randomized Noninferiority Trial of Telephone vs In-Person Genetic Counselling for Hereditary Breast and Ovarian Cancer: A 12-Month Follow-Up. JNCI Cancer Spectrum 1(1): pkx002 [PMC free article: PMC6611491] [PubMed: 31304457]	Outcomes do not match those specified in this review protocol
Kaufman, E. M., Peshkin, B. N., Lawrence, W. F. et al. (2003) Development of an Interactive Decision Aid for Female BRCA1/BRCA2 Carriers. Journal of Genetic Counselling 12(2): 109–29 [PubMed: 26140844]	Study design not relevant to this review protocol
Kautz-Freimuth, S., Redaelli, M., Rhiem, K. et al. (2021) Development of decision aids for female BRCA1 and BRCA2 mutation carriers in Germany to support preference-sensitive decision-making. BMC Medical Informatics & Decision Making 21(1): 180 [PMC free article: PMC8180100] [PubMed: 34090422]	Study design not relevant to this review protocol
Kinney, A. Y., Steffen, L. E., Brumbach, B. H. et al. (2016) Randomized Noninferiority Trial of Telephone Delivery of BRCA1/2 Genetic Counselling Compared With In-Person Counselling: 1-Year Follow-Up. Journal of Clinical Oncology 34(24): 2914–24 [PMC free article: PMC5012661] [PubMed: 27325848]	Outcomes do not match those specified in this review protocol
Korfage, I. J., Fuhrel-Forbis, A., Ubel, P. A. et al. (2013) Informed choice about breast cancer prevention: randomized controlled trial of an online decision aid intervention. Breast Cancer Research 15(5): r74 [PMC free article: PMC3978729] [PubMed: 24004815]	Intervention in study does not match that specified in this review protocol
Krassuski, L. M., Kautz-Freimuth, S., Vennedey, V. et al. (2021) Decision Aids for Preventive Treatment Alternatives for BRCA1/2 Mutation Carriers: a Systematic Review. Geburtshilfe und Frauenheilkunde 81(6): 679–698 [PMC free article: PMC8216782] [PubMed: 34168381]	Systematic review used as source of primary studies
Krassuski, L., Vennedey, V., Stock, S. et al. (2019) Effectiveness of decision aids for female BRCA1 and BRCA2 mutation carriers: a systematic review. BMC Medical Informatics & Decision Making 19(1): 154 [PMC free article: PMC6670224] [PubMed: 31370837]	Systematic review used as source of primary studies
Kukafka, Rita, Pan, Samuel, Silverman, Thomas et al. (2022) Patient and Clinician Decision Support to Increase Genetic Counseling for Hereditary Breast and Ovarian Cancer Syndrome in Primary Care: A Cluster Randomized Clinical Trial. JAMA network open 5(7): e2222092 [PMC free article: PMC9294997] [PubMed: 35849397]	Intervention in study does not match that specified in this review protocol
LeCompte, C.G., McDougall, J., Walters, S.T. et al. (2022) Understanding Cancer Genetic Risk Assessment Intentions in a Tailored Risk Communication Intervention Randomized Controlled Trial. Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology 31(7): 1513–1514	Outcomes do not match those specified in this review protocol
Lee, S. I., Patel, M., Dutton, B. et al. (2020) Effectiveness of interventions to identify and manage patients with familial cancer risk in primary care: a systematic review. Journal of Community Genetics 11(1): 73–83 [PMC free article: PMC6962422] [PubMed: 31062229]	Outcomes do not match those specified in this review protocol
Lobb, E., Butow, P., Meiser, B. et al. (2002) The use of audiotapes in consultations with women from high risk breast cancer families: a randomised trial. Journal of medical genetics 39(9): 697–703 [PMC free article: PMC1735239] [PubMed: 12205117]	Outcomes do not match those specified in this review protocol
Matloff, E. T., Moyer, A., Shannon, K. M. et al. (2006) Healthy women with a family history of breast cancer: impact of a tailored genetic counselling intervention on risk perception, knowledge, and menopausal therapy decision making. Journal of Women’s Health 15(7): 843–56 [PubMed: 16999640]	Population not relevant to this review protocol
McCuaig, J. M., Tone, A. A., Maganti, M. et al. (2019) Modified panel-based genetic counseling for ovarian cancer susceptibility: A randomized non-inferiority study. Gynecologic Oncology 153(1): 108–115 [PubMed: 30638766]	Intervention in study does not match that specified in this review protocol
McGahan, L., Kakuma, R., Ho, C. et al. (2006) BRCA1 and BRCA2 predictive genetic testing for breast and ovarian cancers: a systematic review of clinical evidence	Intervention in study does not match that specified in this review protocol
McGahan, L., Kakuma, R., Ho, C. et al. (2006) A clinical systematic review of BRCA1 and BRCA2 genetic testing for breast and ovarian cancers	Intervention in study does not match that specified in this review protocol
McInerney-Leo, A., Biesecker, B. B., Hadley, D. W. et al. (2004) BRCA1/2 testing in hereditary breast and ovarian cancer families: effectiveness of problem-solving training as a counselling intervention. American Journal of Medical Genetics. Part A 130a(3): 221–7 [PubMed: 15378542]	Intervention in study does not match that specified in this review protocol
Meilleur, K. G. and Littleton-Kearney, M. T. (2009) Interventions to improve patient education regarding multifactorial genetic conditions: a systematic review. American Journal of Medical Genetics. Part A 149a(4): 819–30 [PMC free article: PMC2776676] [PubMed: 19291763]	Systematic review used as source of primary studies
Meisel, S. F., Freeman, M., Waller, J. et al. (2017) Impact of a decision aid about stratified ovarian cancer risk-management on women’s knowledge and intentions: a randomised online experimental survey study. BMC Public Health 17(1): 882 [PMC free article: PMC5689140] [PubMed: 29145813]	Population not relevant to this review protocol
Metcalfe, K. A., Dennis, C. L., Poll, A. et al. (2017) Effect of decision aid for breast cancer prevention on decisional conflict in women with a BRCA1 or BRCA2 mutation: a multisite, randomized, controlled trial. Genetics in Medicine 19(3): 330–336 [PubMed: 27584910]	Intervention in study does not match that specified in this review protocol
Miller, S. M., Fleisher, L., Roussi, P. et al. (2005) Facilitating informed decision making about breast cancer risk and genetic counselling among women calling the NCI’s Cancer Information Service. Journal of Health Communication 10suppl1: 119–36 [PubMed: 16377604]	Outcomes do not match those specified in this review protocol
Miller, S. M., Roussi, P., Daly, M. B. et al. (2005) Enhanced counselling for women undergoing BRCA1/2 testing: impact on subsequent decision making about risk reduction behaviors. Health Education & Behavior 32(5): 654–67 [PubMed: 16148211]	Narrative review
Miller, S. M., Roussi, P., Daly, M. B. et al. (2010) New strategies in ovarian cancer: uptake and experience of women at high risk of ovarian cancer who are considering risk-reducing salpingo-oophorectomy. Clinical Cancer Research 16(21): 5094–106 [PMC free article: PMC3107031] [PubMed: 20829330]	Systematic review used as source of primary studies
Nelson, H. D., Fu, R., Goddard, K. et al. (2013) Risk assessment, genetic counselling, and genetic testing for BRCA-related cancer in women: a systematic review to update the U.S. Preventive Services Task Force recommendation. Agency for Healthcare Research and Quality: 12 [PubMed: 24432435]	Systematic review used as source of primary studies
Nelson, H. D., Fu, R., Goddard, K. et al. (2014) Risk assessment, genetic counselling, and genetic testing for BRCA-related cancer: systematic review to update the U.S. preventive services task force recommendation [PubMed: 24432435]	Systematic review used as source of primary studies
Nelson, H. D., Pappas, M., Cantor, A. et al. (2019) Risk Assessment, Genetic Counselling, and Genetic Testing for BRCA-Related Cancer in Women: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force. JAMA 322(7): 666–685 [PubMed: 31429902]	Systematic review used as source of primary studies
Nelson, H. D., Pappas, M., Cantor, A. et al. (2019) Risk Assessment, Genetic Counselling, and Genetic Testing for BRCA1/2-Related Cancer in Women: A Systematic Review for the U.S. Preventive Services Task Force [Internet]. Agency for Healthcare Research and Quality: 08 [PubMed: 31479213]	Systematic review used as source of primary studies
Obeidat, R.; Finnell, D. S.; Lally, R. M. (2011) Decision aids for surgical treatment of earlystage breast cancer: a narrative review of the literature. Patient education and counselling 85(3): e311–21 [PubMed: 21543184]	Population not relevant to this review protocol
Owens, R. G., Ashcroft, J. J., Leinster, S. J. et al. (1987) Informal decision analysis with breast cancer patients: an aid to psychological preparation for surgery. Journal of Psychosocial Oncology 5: 23–33	Population not relevant to this review protocol
Peshkin, B. N., Kelly, S., Nusbaum, R. H. et al. (2016) Patient Perceptions of Telephone vs. In-Person BRCA1/BRCA2 Genetic Counselling. Journal of Genetic Counselling 25(3): 472–82 [PMC free article: PMC4829475] [PubMed: 26455498]	Outcomes do not match those specified in this review protocol
Pruthi, S.; Gostout, B. S.; Lindor, N. M. (2010) Identification and Management of Women With BRCA Mutations or Hereditary Predisposition for Breast and Ovarian Cancer. Mayo Clinic Proceedings 85(12): 1111–20 [PMC free article: PMC2996153] [PubMed: 21123638]	Narrative review
Roshanai, A. H., Rosenquist, R., Lampic, C. et al. (2009) Does enhanced information at cancer genetic counselling improve counselees’ knowledge, risk perception, satisfaction and negotiation of information to at-risk relatives?-a randomized study. Acta Oncologica 48(7): 999–1009 [PubMed: 19636983]	Population not relevant to this review protocol
Schwartz, M. D., Peshkin, B. N., Isaacs, C. et al. (2018) Randomized trial of proactive rapid genetic counselling versus usual care for newly diagnosed breast cancer patients. Breast Cancer Research & Treatment 170(3): 517–524 [PMC free article: PMC6026034] [PubMed: 29611029]	Intervention in study does not match that specified in this review protocol
Schwartz, M. D., Peshkin, B. N., Tercyak, K. P. et al. (2005) Decision making and decision support for hereditary breast-ovarian cancer susceptibility. Health Psychology 24(4 SUPPL.): S78–S84 [PubMed: 16045423]	Narrative review
Skrovanek, E., Dunbar-Jacob, J., Dunwoody, C. et al. (2020) Integrative Review of Reproductive Decision Making of Women Who Are BRCA Positive. JOGNN - Journal of Obstetric, Gynecologic, & Neonatal Nursing 49(6): 525–536 [PubMed: 32926832]	Systematic review used as source of primary studies
Stacey, D., Légaré, F., Lewis, K. et al. (2017) Decision aids for people facing health treatment or screening decisions. Cochrane Database of Systematic Reviews [PMC free article: PMC6478132] [PubMed: 28402085]	Systematic review used as source of primary studies
Stalmeier, P. F. and Roosmalen, M. S. (2009) Concise evaluation of decision aids. Patient Education & Counselling 74(1): 104–9 [PubMed: 18775622]	Intervention in study does not match that specified in this review protocol
Tea, M. M., Tan, Y. Y., Staudigl, C. et al. (2018) Improving comprehension of genetic counselling for hereditary breast and ovarian cancer clients with a visual tool. PLoS ONE [Electronic Resource] 13(7): e0200559 [PMC free article: PMC6042777] [PubMed: 30001421]	Study design not relevant to this review protocol
Tutty, E., Petelin, L., McKinley, J. et al. (2019) Evaluation of telephone genetic counselling to facilitate germline BRCA1/2 testing in women with high-grade serous ovarian cancer. Eur J Hum Genet 27(8): 1186–1196 [PMC free article: PMC6777607] [PubMed: 30962500]	Study design not relevant to this review protocol
Waljee, J. F.; Rogers, M. A.; Alderman, A. K. (2007) Decision aids and breast cancer: do they influence choice for surgery and knowledge of treatment options? Journal of clinical oncology official journal of the American Society of Clinical Oncology 25(9): 1067–73 [PubMed: 17369570]	Population not relevant to this review protocol
Wang, Catharine Chia-Ling (2003) Decision making in the context of genetic testing for hereditary breast and ovarian cancer: Key predictors and influences. Dissertation Abstracts International: Section B: The Sciences and Engineering 64(6b)	Study design not relevant to this review protocol
Wevers, M. R., Aaronson, N. K., Bleiker, E. M. A. et al. (2017) Rapid genetic counselling and testing in newly diagnosed breast cancer: Patients’ and health professionals’ attitudes, experiences, and evaluation of effects on treatment decision making. Journal of Surgical Oncology 116(8): 1029–1039 [PubMed: 28703900]	Intervention in study does not match that specified in this review protocol
Widmer, Colin L., Wolfe, Christopher R., Reyna, Valerie F. et al. (2015) Tutorial dialogues and gist explanations of genetic breast cancer risk. Behavior Research Methods 47(3): 632–648 [PubMed: 25921818]	Population not relevant to this review protocol
Williams, L., Jones, W., Elwyn, G. et al. (2008) Interactive patient decision aids for women facing genetic testing for familial breast cancer: a systematic web and literature review. Journal of Evaluation in Clinical Practice 14(1): 70–4 [PubMed: 18211647]	Systematic review used as source of primary studies
Witt, J., Elwyn, G., Wood, F. et al. (2014) Adapting the coping in deliberation (CODE) framework: a multi-method approach in the context of familial ovarian cancer risk management. Patient Education & Counselling 97(2): 200–10 [PubMed: 25064250]	Study design not relevant to this review protocol
Zhao, A., Larbi, M., Miller, K. et al. (2021) A scoping review of interactive and personalized web-based clinical tools to support treatment decision making in breast cancer. Breast (Edinburgh, Scotland) 61: 43–57 [PMC free article: PMC8669108] [PubMed: 34896693]	Intervention in study does not match that specified in this review protocol
Zilliacus, E. M., Meiser, B., Lobb, E. A. et al. (2011) Are videoconferenced consultations as effective as face-to-face consultations for hereditary breast and ovarian cancer genetic counselling? Genet Med 13(11): 933–41 [PubMed: 21799430]	Study design not relevant to this review protocol

Support interventions

Interventions to support decision making about management options for women at increased risk of ovarian cancer

Review question

Introduction

Summary of the protocol

Table 1

Methods and process

Effectiveness evidence

Included studies

Excluded studies

Summary of included studies

Table 2

Summary of the evidence

Genetic counselling versus usual care

Genetic counselling plus decision support intervention versus genetic counselling alone

Telephone genetic counselling versus in-person genetic counselling

Group education session followed by individual genetic counselling versus individual education and genetic counselling

Decision support versus usual care in BRCA1/2 mutation carriers

Education app versus usual care (pre genetic counselling)

Economic evidence

Included studies

Excluded studies

Summary of included economic evidence

DVD-assisted genetic counselling for BRCA1/2

Telephone pre- and post-test genetic counselling for BRCA1/2

Table 3

Table 4

Economic model

Evidence statements

Economic

DVD-assisted genetic counselling for BRCA1/2

Telephone pre- and post-genetic counselling for BRCA1/2

The committee’s discussion and interpretation of the evidence

The outcomes that matter most

The quality of the evidence

Benefits and harms

Cost effectiveness and resource use

Other factors the committee took into account

Recommendations supported by this evidence review

References – included studies

Effectiveness

Economic

Appendices

Appendix A. Review protocol

Appendix B. Literature search strategies

Appendix C. Effectiveness evidence study selection

Appendix D. Evidence tables

Appendix E. Forest plots

Appendix F. GRADE tables

Appendix G. Economic evidence study selection

Study selection for: Which interventions are effective for supporting women at increased risk of ovarian cancer to make decisions about management options?

Appendix H. Economic evidence tables

Appendix I. Economic model

Economic model for review question: Which interventions are effective for supporting women at increased risk of ovarian cancer to make decisions about management options?

Appendix J. Excluded studies

Excluded studies for review question: Which interventions are effective for supporting women at increased risk of ovarian cancer to make decisions about management options?

Excluded effectiveness studies

Table 15

Excluded economic studies

Appendix K. Research recommendations – full details

K.1. Research recommendation

Table 1Summary of the protocol (PICO table)

Table 2Summary of included studies

Table 3Economic evidence profile for DVD-assisted genetic counselling (DVD-C) for BRCA1/2 versus traditional face-to-face counselling (TC) only for BRCA1/2

Table 4Economic evidence profiles for telephone pre- and post-test genetic counselling (TC) for BRCA1/2 versus in-person pre- and post-test genetic counselling (SC) for BRCA1/2

Table 15Excluded studies and reasons for their exclusion