Opening the Conversation: study protocol for a Phase III trial to evaluate a couple-based intervention to reduce reproductive and sexual distress among young adult breast and gynecologic cancer survivor couples.

BACKGROUND: Reproductive and sexual health (RSH) concerns are common and distressing for young adults diagnosed with breast and gynecologic cancer and their partners. This study evaluates the efficacy of a virtual couple-based intervention called Opening the Conversation (OC). The OC intervention is grounded in theory and evidence-based practice and was adapted to improve coping and communication specifically in relation to RSH concerns after cancer. METHODS: This Phase III trial is conducted in a fully remote setting and enrolls young adult couples (current age 18-44 years) with a history of breast or gynecologic cancer (stage 1-4, diagnosed under age 40) within the past 6 months to 5 years. Eligible dyads are recruited from across the USA. The target sample size is 100 couples. Dyads are randomly assigned to receive either the 5-session OC intervention or a 4-session active control intervention (Side by Side). The primary outcomes are change in reproductive distress and sexual distress. Secondary outcomes include communication about reproductive concerns, communication about sexual concerns, depressive symptoms, sexual function, relationship quality, relationship intimacy, sexual satisfaction, self-efficacy to communicate about sex and intimacy, and quality of life. An exploratory aim examines whether dyadic coping and communication quality mediate intervention effects on survivors' and partners' reproductive distress or sexual distress. Self-report outcome measures are assessed for both groups at baseline (T1), 2 weeks post-treatment (T2), and 3 months post-treatment (T3). DISCUSSION: Despite the importance of RSH for quality of life for young adult cancer survivors and their partners, evidence-based interventions that help couples navigate RSH concerns are lacking. This randomized controlled trial will determine the efficacy of a novel couple-based intervention to reduce distress related to RSH concerns for younger couples after breast or gynecologic cancer, in comparison to an active control intervention. TRIAL REGISTRATION: ClinicalTrials.gov NCT04806724. Registered on Mar 19, 2021.

Adapting a Theory-Informed Intervention to Help Young Adult Couples Cope With Reproductive and Sexual Concerns After Cancer.

OBJECTIVE: Most young adults diagnosed with breast or gynecologic cancers experience adverse reproductive or sexual health (RSH) outcomes due to cancer and its treatment. However, evidence-based interventions that specifically address the RSH concerns of young adult and/or LGBTQ+ survivor couples are lacking. Our goal is to develop a feasible and acceptable couple-based intervention to reduce reproductive and sexual distress experience by young adult breast and gynecologic cancer survivor couples with diverse backgrounds. METHODS: We systematically adapted an empirically supported, theoretically grounded couple-based intervention to address the RSH concerns of young couples coping with breast or gynecologic cancer through integration of stakeholder perspectives. We interviewed 11 couples (22 individuals) with a history of breast or gynecologic cancer to review and pretest intervention materials. Three of these couples were invited to review and comment on intervention modifications. Content experts in RSH and dyadic coping, clinicians, and community advisors (one heterosexual couple and one LGBTQ+ couple, both with cancer history) participated throughout the adaptation process. RESULTS: Findings confirmed the need for an online, couple-based intervention to support young couples experiencing RSH concerns after breast or gynecologic cancer. Qualitative themes suggested intervention preferences for: (1) A highly flexible intervention that can be tailored to couples' specific RSH concerns; (2) Active steps to help members of a dyad "get on the same page" in their relationship and family building plans; (3) A specific focus on raising partners' awareness about how cancer can affect body image and physical intimacy; and (4) Accessible, evidence-based information about RSH for both partners. These results, along with feedback from stakeholders, informed adaptation and finalization of the intervention content and format. The resulting virtual intervention, Opening the Conversation, includes five weekly sessions offering training to couples in communication and dyadic coping skills for addressing RSH concerns. CONCLUSION: The systematic adaptation process yielded a theory-informed intervention for young adult couples facing breast and gynecological cancers, which will be evaluated in a randomized controlled trial. The long-term goal is to implement and disseminate Opening the Conversation broadly to reach young adult couples with diverse backgrounds who are experiencing RSH concerns in cancer survivorship.