JMIR Publications

ABSTRACT

Background:

Although most 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 treatment. Even when delivered remotely, survivor time constraints remain a leading barrier to sexual health intervention uptake.

Objective:

Guided by the Multiphase Optimization Strategy methodological framework, the primary objective of this study is to identify the most efficient internet-delivered sexual health intervention package that is expected to provide breast cancer survivors the greatest benefit with the fewest (and least-intensive) intervention components. Secondarily, this study also aims to determine how intervention components work (i.e., mediators) and for whom they work best (i.e., moderators).

Methods:

Partnered, post-treatment adult female breast cancer survivors (N=320) experiencing at least 1 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 the Wake Forest National Cancer Institute (NCI) Community Oncology Research Program (NCORP) Research Base. Participants will be randomly assigned to 1 of 16 combinations of 4 intervention components with 2 levels each in this factorial trial: psychoeducation about cancer-related sexual morbidity (receive either enhanced vs. standard versions); communication skills training for discussing concerns with health care providers (receive vs. do not receive); communication skills training for discussing concerns with a partner (receive vs. do not receive); and intimacy promotion skills training (receive vs. do not receive). Cores will be implemented using a robust internet intervention platform with highly-engaging elements like animation, video, and automated email prompts. Survivors will complete online assessments at baseline (pre-randomization) and again at 12- and 24-weeks later. The primary study aim will be achieved through a decision-making process based on systematically evaluating main and interaction effects of components on sexual distress (Female Sexual Distress Scale–Desire, Arousal, Orgasm) and sexual functioning (Female Sexual Functioning Inventory) using a General Linear Model (GLM) approach to ANOVA with effect coding. Mediation analyses will be conducted through a structural equation modeling approach, and moderation analyses will be conducted by extending the GLM models to include interaction effects.

Results:

This protocol has been reviewed and approved by the NCI Central Institutional Review Board and is registered through ClinicalTrials.gov (NCT06216574). Data collection is planned to begin Spring 2024 and conclude in 2027.

Conclusions:

By identifying the combination of the fewest and least-intensive intervention components likely to provide breast cancer survivors the greatest sexual health benefit, this study will result in the first internet intervention optimized for maximum impact on the undertreated, prevalent, and distressing problem of breast cancer-related sexual morbidity. Clinical Trial: ClinicalTrials.gov ID – NCT06216574