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Trial Title:
Open Pilot Trial of a Mind-Body Sexual Well-Being Intervention for Female GI Cancer Survivors
NCT ID:
NCT06331403
Condition:
Colorectal Cancer
Anal Cancer
Sexual Dysfunction
Conditions: Official terms:
Colorectal Neoplasms
Anus Neoplasms
Conditions: Keywords:
sexual well-being
women's health
colorectal cancer
anal cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Mind-Body Group Intervention
Description:
Weekly virtual group meetings with the study interventionist(s) and up to 9 other female
cancer survivors over an approximately 6 week period. The group program includes topics
related to coping with physical health changes, managing social factors relevant to
sexual well-being, and managing thoughts and feelings related to sexual well-being
changes.
Arm group label:
Mind-Body Sexual Well-Being Group Intervention
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.
Criteria for 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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Massachusetts General Hospital Cancer Center
Address:
City:
Boston
Zip:
02115
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lucy Finkelstein-Fox, PhD
Phone:
617-724-6300
Phone ext:
1111330076
Email:
lfinkelsteinfox@mgh.harvard.edu
Start date:
July 10, 2024
Completion date:
April 2025
Lead sponsor:
Agency:
Massachusetts General Hospital
Agency class:
Other
Collaborator:
Agency:
Harvard Medical School (HMS and HSDM)
Agency class:
Other
Source:
Massachusetts General Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06331403
