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NOT YET RECRUITING
NCT07795801
NA

Mind-Body Sexual Well-Being Program for Female GI Cancer Survivors

Sponsor: Massachusetts General Hospital

View on ClinicalTrials.gov

Summary

This record describes two distinct study phases: 1) A small open pilot trial including up to 10 participants, intended to generate descriptive feedback on regarding perceived benefits and areas for improvement for a group-based mind-body sexual well-being program for women treated for colorectal and anal cancers and 2) A pilot randomized controlled trial (RCT) including up to 100 participants, intended to provide information about feasibility, acceptability, and preliminary efficacy of the group-based mind-body sexual well-being program compared to enhanced usual care control (EUCC). Given the early-stage, open-pilot nature of the first study phase, which is not intended to produce interpretable results for feasibility, acceptability, or efficacy, this record will only report results from the second study phase (pilot RCT).

Official title: Refining a Mind-Body Sexual Well-Being Program for Female GI Cancer Survivors

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2026-10-01

Completion Date

2029-06-01

Last Updated

2026-09-08

Healthy Volunteers

No

Interventions

BEHAVIORAL

Mind-Body Group Intervention

Weekly virtual group meetings with the study interventionist(s) and up to 9 other female cancer survivors over an approximately 6 week period. The group program includes topics related to coping with physical health changes, managing social factors relevant to sexual well-being, and managing thoughts and feelings related to sexual well-being changes.

BEHAVIORAL

Enhanced Usual Care Control (EUCC)

Participants randomized to EUCC will not receive any components of the mind-body group intervention. After randomization, the study CRC will offer participants a handout listing information about sexual health resources currently available to them that they may choose to access. Participants in the EUCC condition will also have the option of seeking care through the cancer center's local sexual health program, as is the current standard of care.

Locations (1)

Mass General Brigham Cancer Institute

Boston, Massachusetts, United States