Design of a randomized controlled trial on the efficacy of a reproductive health survivorship care plan in young breast cancer survivors

Stark, Shaylyn S.; Chingos, Diana T.; Ehren, Jennifer; Gorman, Jessica R.; Krychman, Michael; Kwan, Brian; Mao, Jun J.; Myers, Emily; Walpole, Tom; Pierce, John P.; Su, H. Irene

doi:10.1016/j.cct.2018.12.002

Cited by 11 publications

(6 citation statements)

References 43 publications

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“…The high proportion of women eligible in a short time frame suggests that the recruitment methods yielded suitable women very efficiently. Our success with social media recruitment aligns with other studies (Gorman et al, 2014 ; Stark et al, 2019 ) and highlights the importance of community members helping to define and implement recruitment strategies.…”

Section: Discussionsupporting

confidence: 86%

A remotely delivered, peer-led intervention to improve physical activity and quality of life in younger breast cancer survivors

Weiner

Nagel²,

et al. 2022

J Behav Med

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Younger breast cancer survivors (YBCS) consistently report poorer quality of life (QOL) than older survivors. Increasing physical activity (PA) may improve QOL, but this has been understudied in YBCS. This single arm pilot study evaluated the feasibility and acceptability of a 3-month, peer-delivered, remote intervention to increase PA and improve QOL in YBCS. Data were collected from October 2019 – July 2020. Participants (n = 34, 43.1 ± 5.5 years old, 46 ± 34.4 months post-diagnosis, BMI = 30.2 ± 7.4 kg/m2) completed six video sessions with a trained peer mentor; self-monitored PA with a Fitbit activity tracker; and interacted with a private Fitbit Community for social support. At baseline, 3-and 6-months, participants completed QOL questionnaires and PA was measured through accelerometer (moderate-to-vigorous PA [MVPA]) and self-report (strength and flexibility). A parallel mixed-methods approach (qualitative interviews and quantitative satisfaction survey at 3-months) explored intervention feasibility and acceptability. One-way repeated-measures ANOVAs examined impacts on PA and QOL at 3-and 6-months. The intervention was feasible as evidenced by efficient recruitment, high retention, and adherence to intervention components. Remote delivery, working with a peer mentor, and using Fitbit tools were highly acceptable. From baseline to 3-months, participants increased time spent in objectively measured MVPA, strength, and flexibility exercises, and reported meaningful improvements to body image, fatigue, anxiety, and emotional support. A fully remote, peer-to-peer intervention is an acceptable and promising strategy to increase PA and improve QOL in YBCS. Refinements to the intervention and its delivery should be further assessed in future studies, toward the goal of disseminating an evidence-based, scalable intervention to the growing number of YBCS.Trial registration Prospectively registered as NCT04064892.

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Section: Discussionsupporting

confidence: 86%

A remotely delivered, peer-led intervention to improve physical activity and quality of life in younger breast cancer survivors

Weiner

Nagel²,

et al. 2022

J Behav Med

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“…However, the information given should be accurate, attainable, and standardized to meet women's reproductive and sexual health needs ( 32 ). These findings are also in line with the results of the aforementioned studies ( 34 , 35 ).…”

Section: Discussionsupporting

confidence: 92%

Overcoming Reproductive and Psychological Concerns of Breast Cancer Survivors: A Randomized Controlled Trial

Barjasteh¹,

Farnam²,

Elsous³

et al. 2022

JFRH

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Objective: After developing breast cancer, women experience changes in their sexuality, femininity, and fertility. These changes lead to poor mental health and increased psychological stress. Therefore, this study aimed to investigate the effects of Good Enough Sex (GES)-based, couple-centered group counseling on reproductive and sexual concerns of breast cancer survivors. Materials and methods: This was a quantitative randomized controlled clinical trial (RCT) conducted at Omid Hospital, West Azerbaijan, Urmia, Iran from March 2018 to October 2020. After completing the informed consent forms, 100 women were assigned to the intervention and control groups (50 individuals per group) using a randomized block design. The intervention included four 90-120-minute sexual counseling sessions with 2 and 3 month follow-ups. The data were collected using the socio-demographic and clinical characteristics, the Persian version of Depression, Anxiety and Stress Scale (DASS-21), Reproductive Concerns after Cancer (RCAC) scale, and Female Sexual Function Index adaptation for Breast Cancer patients (FSFI-BC). Data were collected, from control and intervention groups, at three intervals; before, besides two months and three months post intervention, then were analyzed in SPSS 20 using descriptive and repeated measures analysis of variance (ANOVA) test. Results: Significant reduction in the mean score of DASS-21, RCAC and improvement of FSFI-BC is reported between the intervention and control groups in favor of intervention group (P<0.001). However, no significant differences are observed within intervention group over two- and three-months post intervention (P > 0.05). Conclusion: The designed Good Enough Sex (GES)-based, couple-centered group counseling effectively reduced reproductive and sexual concerns of females’ breast cancer survivors. Therefore, these training and counseling programs can be organized by relevant service centers to promote the reproductive health of women with breast cancer.

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“…Although it is well accepted that fertility-related distress after cancer is common, particularly among females,9 there is a lack of support resources for post-treatment survivors. Multiple cancer and fertility decision aids and support interventions exist for YA-Fs considering pretreatment fertility preservation 10–15. Consistent with the decision science literature,16 these studies demonstrate the benefit of decision aids for YA-Fs facing fertility decisions.…”

Section: Introductionsupporting

confidence: 69%

Family-building decision aid and planning tool for young adult women after cancer treatment: protocol for preliminary testing of a web-based decision support intervention in a single-arm pilot study

et al. 2019

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IntroductionMany young adult female (YA-F) cancer survivors who received gonadotoxic therapy will experience fertility problems. After cancer, having a child will often require assisted reproductive technology (ART), surrogacy or adoption. However, there are significant informational, psychosocial, financial and logistical barriers to pursuing these options. Survivors report high rates of decision uncertainty and distress related to family-building decisions. The aim of this study is to pilot test a web-based decision aid and planning tool for family-building after cancer.Methods and analysisThe pilot study will use a single-arm trial design to test the feasibility and acceptability (aim 1) and obtain effect size estimates of the decision support intervention (aim 2). The target sample size is 100. Participants will include YA-F survivors (aged 18–45 years) who are post-treatment and have not completed desired family-building. A longitudinal prepost design will be conducted. Participants will complete three psychosocial assessment surveys over a 3-month time period to track decisional conflict (primary outcome) and cognitive, emotional, and behavioural functioning (secondary outcomes). After completing the baseline survey (T1; pre-intervention), participants will have access to the decision aid website. Postintervention surveys will be administered at 1-month (T2) and 3-month (T3) follow-up time points. Feasibility and acceptability metrics will be analysed. Pairwise t-tests will test mean scores of outcome variables from T1 to T2. Effect size estimates (Cohen’s d) will be calculated. Google analytics will evaluate user engagement with the website over the study period. Baseline and follow-up data will examine measures of feasibility, acceptability and intervention effect size.Ethics and disseminationThis will be the first test of a supportive intervention to guide YA-F cancer survivors in family-building decisions and early planning. Study findings will inform intervention development. Future directions will include a randomised controlled trial to test intervention efficacy over a longer time period.Trial registration number NCT04059237; Pre-results.

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Design of a randomized controlled trial on the efficacy of a reproductive health survivorship care plan in young breast cancer survivors

Abstract: Background: Young breast cancer survivors (YBCS) have unmet needs for managing hot flashes, fertility-related concerns, sexual health and contraception.

Cited by 11 publications

References 43 publications

A remotely delivered, peer-led intervention to improve physical activity and quality of life in younger breast cancer survivors

A remotely delivered, peer-led intervention to improve physical activity and quality of life in younger breast cancer survivors

Overcoming Reproductive and Psychological Concerns of Breast Cancer Survivors: A Randomized Controlled Trial

Family-building decision aid and planning tool for young adult women after cancer treatment: protocol for preliminary testing of a web-based decision support intervention in a single-arm pilot study

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