This clinical trial studies the use of a couple-based sexual quality of life intervention called Adapted Intimacy Enhancement (AIE) in improving sexual and psychosocial outcomes in women with breast cancer that has spread to other places in the body (metastatic) and their partners. AIE program provides education, skills training and practice and may enhance intimacy, sexual well-being, and relationship quality in women with metastatic breast cancer and their partners.
Additional locations may be listed on ClinicalTrials.gov for NCT05636943.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVES:
I. To adapt the AIE intervention for use with couples facing metastatic breast cancer (MBC).
II. To evaluate the efficacy of the AIE intervention on patient and partner sexual and psychosocial outcomes.
EXPLORATORY OBJECTIVE:
I. To examine an objective measure of communal coping with sexual concerns and its associations with improvements in patients’ sexual outcomes among couples in the AIE condition.
OUTLINE:
AIM I: Participants participate in focus group over 90 minutes and complete cognitive interview over 60 minutes.
AIM II: Participants are randomized to 1 of 2 arms.
ARM A (AIE): Participants receive the AIE intervention consisting of a sexual quality of life phone session over 60-75 minutes every 2 weeks for 8 weeks.
ARM B (ENHANCED USUAL CARE): Participants receive information and support phone session every 2 weeks for 8 weeks.
After completion of study, participants are followed up at 6 months.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationFox Chase Cancer Center
Principal InvestigatorJennifer B. Reese