NCT07795801Not yet recruiting
Mind-Body Sexual Well-Being Program for Female GI Cancer Survivors
Refining a Mind-Body Sexual Well-Being Program for Female GI Cancer Survivors
Source: ClinicalTrials.gov · Last updated 8 Sept 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 25 Aug 2026
- Start date
- Oct 2026
- Primary completion date
- Jun 2029
- Lead sponsor
- Massachusetts General Hospital
- Diseases
- Colorectal cancer
- NCT number
- NCT07795801
What you commit to
- Study type: Interventional
- Planned participants: 100
- From Oct 2026 to the primary completion date, Jun 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Active psychiatric or cognitive comorbidity that prohibits the capacity to provide informed consent as determined by the study PI, a licensed psychologist, in collaboration with the patient's medical team
Age
- Participated in an earlier phase of the study (DF-HCC protocols #22-586, #24-009, #24-281).
- In addition, individuals who participate in Phase 1 of this protocol (open pilot trial) will not be eligible to participate in Phase 2 (pilot RCT). Investigators will not enroll the following special populations: adults unable to consent, individuals who are not yet adults (i.e., \< age 18), pregnant women, and prisoners.
Other
- Adults unable to complete study procedures in English
Who the study is looking for
- Female sex
- Able to speak and read English
- Aged 18 or older
- Receive any cancer care at any MGH-CC site (Boston, Waltham, Danvers, Newton Wellesley Hospital)
- Completed initial active treatment (i.e., surgery, radiation, chemotherapy) for colorectal or anal cancer approximately 3 months or more prior to enrollment (for curvivors/individuals treated for cancer with curative intent) or were diagnosed at least 3 months ago (for metavivors/individuals living with chronic cancer)
- Verbally endorse experiencing distressing changes to sexual health or intimate relationships, including changes that may be related to cancer diagnosis and treatment
- Access to an internet-connected device with video
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mass General Brigham Cancer Institute Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.