N/A
Completed N=6
Open Pilot Trial of a Mind-Body Sexual Well-Being Intervention for Female GI Cancer Survivors
Source: ClinicalTrials.gov NCT06331403 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcomePrimary: Feasibility of Intervention — 6 Participants
Summary
The primary goal of this protocol is to conduct an open pilot to collect initial quantitative and qualitative feedback on the intervention that the investigators are developing. To do so, the investigators will deliver a newly-developed intervention to up to 2 consecutive groups of female colorectal and anal cancer survivors (n = up to 10 per group, total N = up to 20). Participants will provide feedback regarding intervention acceptability, feasibility, and perceived benefit.
To inform plans for ongoing program refinement, the investigators will elicit specific feedback about study assessment tools, recruitment procedures, and group factors. Given the early-stage, open pilot nature of this protocol, the investigators will not set strict criteria to establish feasibility and acceptability but will rather interpret each of these outcomes holistically. Qualitative feedback collected in post-intervention exit interviews will also support understanding of feasibility and acceptability.
As a secondary aim, the investigators will explore the preliminary effects of the intervention on psychosocial measures of satisfaction with sexuality and impact of functional limitations, coping abilities, acceptance of body image changes, loneliness, and anticipated stigma. As noted above, the investigators will not set specific criteria to establish preliminary efficacy, nor will they consider statistical significance as an indicator of the study's efficacy for these outcomes. Instead, the investigators will consider pre-post intervention effect sizes to consider the need for refinement of study procedures/measurement in a future larger trial.
In future, larger-scale, work, the investigators intend to conduct a larger randomized pilot trial to assess intervention acceptability, feasibility, as well as preliminary efficacy on essential outcomes related to sexual well-being.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility of Intervention |
6 | — |
| PRIMARY Acceptability of Intervention |
5 | — |
Eligibility Criteria
Inclusion Criteria
- Female sex
- English-speaking
- Aged 18 or older
- Receive any cancer care at MGH-CC sites (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 OR diagnosed longer than 3 months ago if in metastatic cancer treatment.
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 research study
Data sourced from ClinicalTrials.gov (NCT06331403). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.