(054) OPTIMIZING INTERNET-BASED PSYCHOSOCIAL INTERVENTION FOR BREAST CANCER-RELATED SEXUAL MORBIDITY: PROTOCOL FOR A FACTORIAL TRIAL
Authors: Shaffer K , Reese J , Dressler E V , Cohn W , Glazer J V , Frederick C , Showalter S , Clayton A H , Loch M , Danhauer S C , Collins L , Weaver K E , Lesser G J , Ritterband L 
Published: June 2024

Abstract

Introduction
Although 3 in 4 breast cancer survivors report significant sexual concerns following treatment, few receive support for these concerns. Delivering sexual health care to breast cancer survivors via the Internet could overcome many of the barriers to in-person interactions, including limited availability of resources and stigma. Prior research on telehealth interventions for breast cancer survivors’ sexual health has limitations. First, survivors continue to endorse time burden as a leading reason for declining telehealth sexual health interventions. Second, prior trial designs have not been able to determine which intervention components work best for which survivors. This knowledge is crucial to refine and personalize sexual health care for survivors.

Objective
Use the Multiphase Optimization Strategy (MOST) methodological framework to achieve the following aims: (1) develop an Internet intervention for breast cancer-related sexual health that is optimized for greatest impact; and (2) determine how intervention components work (i.e., mediators) and for whom they work best (i.e., moderators).

Methods
320 partnered, post-treatment female breast cancer survivors who endorse at least one bothersome sexual symptom (i.e., pain with sex, vaginal dryness, low sexual desire, difficulty with orgasm) related to their breast cancer treatment will be enrolled. Recruitment will be conducted via a US-national community oncology research program representing more than 1,000 individual practice locations. In this factorial trial, participants will be randomized to receive a combination of 4 intervention components: psychoeducation about cancer-related sexual morbidity, training for communication with their health care team, training for communication with their partners, and intimacy promotion skills training. These components were selected as they are supported by our intervention research, are consistent with survivorship guidelines, and align with survivors’ preferences found in our qualitative research. Components will be implemented using a robust Internet intervention platform with tailoring and highly-engaging elements like animation, video, and automated email prompts. Survivors will complete assessments at baseline (pre-randomization) and 3- and 6-month post-assessments. First, the impact of intervention components on survivors’ sexual distress (Female Sexual Distress Scale-Desire, Arousal, Orgasm) and sexual functioning (Female Sexual Function Inventory) will be tested. Next, a select set of mediators (i.e., sexual functioning knowledge, sexual communication self-efficacy with clinicians and partner, emotional intimacy with partner) and moderators (i.e., menopausal status, adjuvant endocrine therapy use, psychological distress, relationship duration and satisfaction) will be evaluated.

Results
Institutional review board approvals are in progress, with clinical trial registration to follow. Data collection is anticipated to begin in Spring 2024 and be completed in 2027.

Conclusions
Findings from this trial will accelerate the development of more effective sexual health interventions for breast cancer survivors by determining how intervention components work and for whom various components work best. By identifying the combination of intervention components likely to provide breast cancer survivors the greatest sexual health benefit for the least burden, this study will result in the first Internet intervention optimized for maximum impact for the undertreated, prevalent, and distressing problem of breast cancer-related sexual morbidity.

Disclosure
Any of the authors act as a consultant, employee or shareholder of an industry for: AHC: grants from Janssen, Relmada Therapeutics, Inc., and Sage Therapeutics; personal fees from Acadia, Alkermes, Allergan, AMAG Pharmaceuticals, Inc., Fabre-Kramer, Ovoca Bio plc, Pure Tech Health, Sage Therapeutics, Takeda/Lundbeck, WCG MedAvante-ProPhase, Ballantine Books/Random House, Changes in Sexual Functioning Questionnaire, Guilford Publications; personal fees and other from S1 Biopharma; and other from Euthymics and Mediflix LLC. GL: consultant or research affiliation with Agios Pharmaceuticals, Inc; Denovo Biopharma; IN8bio; Incyte Corporation; Novocure Inc.; oblato; ONO Pharma; Sumitomo Dainippon Pharma Co., Ltd. LR: financial and/or business interest in BeHealth Solutions and is a consultant to Mahana Therapeutics.