Clinical trial NCT06331403: Open Pilot Trial of a Mind-Body Sexual Well-Being Intervention for Female GI Cancer Survivors
Official title: Open Pilot Trial of a Novel Mind-Body Sexual Well-Being Intervention for Female GI Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Anal Cancer
Sexual Dysfunction
Keywords: sexual well-being
women's health
colorectal cancer
anal cancer
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Harvard Medical School (HMS and HSDM)
First posted: 2024-03-26
Enrollment: 6
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: This is an open pilot trial to gather initial data regarding feasibility, acceptability, and perceived impact of a 6-session mind-body group intervention that the investigators are developing to enhance sexual well-being among post-treatment female colorectal and anal cancer survivors.

The investigators will enroll up to 10 women per group into up to 2 groups (total N = up to 20). The team will run groups consecutively so that any necessary changes from the first open pilot group may be incorporated and re-examined in the second.

Participants will complete informed consent prior to initiation of study procedures. To inform ongoing intervention refinement, the investigators will ask participants to complete approximately 15-minute survey batteries via REDCap at baseline and after the 6-session program, including assessments of intervention feasibility and acceptability as well as psychosocial outcomes. Participants will also be invited to complete a brief qualitative exit interview with a member of the study team, regarding perceived benefit of the intervention as well as and strengths and weaknesses of program content and delivery format to inform ongoing intervention refinement.

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

Primary outcomes:
measure: Feasibility of Intervention
timeFrame: Approximately 6 weeks after the final 6-week (up to N=2 groups) group program begins
measure: Acceptability of Intervention
timeFrame: Approximately 6 weeks following group program start
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital Cancer Center
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Lucy Finkelstein-Fox, PhD
role: PRINCIPAL_INVESTIGATOR
References: