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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "To help investigators further refine the sexual well-being program for the next phase of the study, investigators will ask participants to complete brief (approximately 30 minute) survey batteries via REDCap at baseline and after the 6-session program, including assessments of intervention feasibility and acceptability as well as relevant psychosocial outcomes."
  • "Just as for Aim 1, to inform ongoing intervention refinement, investigators will ask all participants to complete brief (approximately 30 minute) survey batteries via REDCap at baseline and after the 6-session program, including items related to feasibility, acceptability, and relevant psychosocial outcomes."
  • "To capture symptom change over a longer period, investigators will also ask participants to complete survey batteries at 3-month post-intervention follow-up."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

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.

Study sites (1)

MA