Clinical trial · Interventional
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
- Retrieved
- Sep 9, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260909-000002
Summary
Brief summary (as posted)
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).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anal Cancer | Malignant Anal Neoplasm | CURATED_EXACT | 0.92 |
| Colorectal Cancer (Diagnosis) | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Sexual Dysfunction Female | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Enhanced Usual Care Control (EUCC) | Behavioral | — | UNRESOLVED |
| Mind-Body Group Intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Mind-Body Sexual Well-Being Group Intervention
- description
- 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.
- interventionNames
- Behavioral: Mind-Body Group Intervention
- type
- ACTIVE_COMPARATOR
- label
- Enhanced Usual Care Control (EUCC)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Female sex 2. Able to speak and read English 3. Aged 18 or older 4. Receive any cancer care at any MGH-CC site (Boston, Waltham, Danvers, Newton Wellesley Hospital) 5. 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) 6. Verbally endorse experiencing distressing changes to sexual health or intimate relationships, including changes that may be related to cancer diagnosis and treatment 7. Access to an internet-connected device with video Exclusion Criteria: * 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 * Adults unable to complete study procedures in English * 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.
References
Publications (0)
Data not yet available