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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT07795801
Status
Not Yet Recruiting

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Conditions

  • Anal Cancer
  • Colorectal Cancer (Diagnosis)
  • Sexual Dysfunction Female

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Mind-Body Group Intervention — BEHAVIORAL
    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.
  • Enhanced Usual Care Control (EUCC) — BEHAVIORAL
    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.

Study Details

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).

Key Dates

First listed
Aug 31, 2026
Start date
Oct 1, 2026
Status verified
Aug 2026
Primary completion
Jun 1, 2029
Completion
Jun 1, 2029

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Mind-Body Sexual Well-Being Group Intervention
    Participants in the mind-body sexual well-being group intervention arm will participate in 6 weekly group sessions, delivered via videoconferencing, following enrollment. Group sessions will include content related to mind-body medicine (e.g., relaxation, mindfulness, self-compassion) applied to sexual well-being as well as educational information related to women's sexual well-being in cancer survivorship. Before and after completing the group program, participants will also complete brief self-assessment questionnaires. Participants in the mind-body group intervention arm will also receive the same educational information about available sexual health resources as the EUCC participants, to ensure equal familiarity with high-quality educational and supportive resources related to women's sexual well-being and cancer.
  • Active Comparator: 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 several high-quality sexual health resources currently available to them.

Primary Outcome Measure

Feasibility of Intervention [ Time Frame: Approximately 6 weeks after the final 6-week group program begins ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mass General Brigham Cancer InstituteBostonMassachusetts02114
Lucy Finkelstein-Fox, PhD
[email protected]
617-726-6300

Find similar trials in Boston, MA

By research site
Mass General Brigham Cancer Institute· Boston, MA

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