A pilot randomized controlled trial of a multicomponent intervention to improve sexual function in female breast cancer survivors.

Sexual health challenges after breast cancer commonly include physical symptoms of genitourinary syndrome of menopause (GSM) (e.g., vaginal pain) and psychological problems (e.g., negative body image) necessitating interventions that address both issues. To assess the feasibility of a multicomponent intervention of hypnotic relaxation and vaginal moisturizer to improve GSM, sexual desire, and body image in female breast cancer survivors. This two-arm pilot randomized controlled trial tested an 8-week self-administered multicomponent intervention, hypnotic relaxation intervention (HRI) with vaginal moisturizer, compared to a vaginal moisturizer-only group (VMO). All participants used vaginal moisturizer daily in weeks 1 and 2. In weeks 3-8, vaginal moisturizer use decreased to every other day. In addition to vaginal moisturizer, HRI participants added hypnotic relaxation 3 times per week in weeks 3-8. Eligible women reported vaginal or vulvar dryness and/or pain with sexual activity, negative body image changes, and/or decreased sexual desire. The primary outcomes were accrual, retention, and adherence rates. Preliminary intervention effects on sexual function were assessed using the Sexual Function Inventory (FSFI) and PROMIS Sexual Function and Satisfaction V2 (SexFS V2) as well as on body image using the Breast Cancer Impact of Treatment Scale (BITS) at baseline and 8 weeks. Thirty participants were randomized to HRI ( n  = 14) or VMO ( n  = 16); all completed the study. Adherence was excellent for both HRI (92%) and VMO (90%). Sexual desire, body image, and GSM-related outcomes (lubrication and pain) improved for both groups. Small to moderate effects were found in the change scores favoring the HRI group compared to the VMO group for SexFS V2 interest ( d  = 0.37) and body image ( d  = 0.42). In the full sample, large effects were found for an increase in lubrication, d  = 1.50 (0.97, 2.02), and a reduction in pain, d  = 0.81 (0.39, 1.22), on the FSFI. This randomized controlled pilot trial supported the feasibility of hypnotic relaxation and vaginal moisturizer for female breast cancer survivors with sexual problems. Hypnotic relaxation coupled with vaginal moisturizer appears to be a promising intervention, particularly for improving body image, and a larger, well-powered study is needed to confirm these findings. ClinicalTrials.gov, Identifier NCT05692960.