Mind-Body Sexual Well-Being Program for Female GI Cancer Survivors
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMassachusetts General Hospital
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female sex
Able to speak and read English
Aged 18 or older
Receive any cancer care at any MGH-CC site (Boston, Waltham, Danvers, Newton Wellesley Hospital)
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Mind-Body Group Intervention
BehavioralWeekly 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.
Enhanced Usual Care Control (EUCC)
BehavioralParticipants 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 sexual health resources currently available to them that they may choose to access. Participants in the EUCC condition will also have the option of seeking care through the cancer center's local sexual health program, as is the current standard of care.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Mind-Body Sexual Well-Being Group InterventionExperimental treatment 1 intervention
Group B: Enhanced Usual Care Control (EUCC)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility of Intervention
To explore feasibility, investigators will use descriptive statistics (i.e., frequency and percentages) to evaluate the proportion of enrolled participants who completed at least 66%, or 4/6, of the scheduled intervention sessions (\>/= 70% as our cutoff criteria for feasibility).
Time frame
Approximately 6 weeks after the final 6-week group program begins2
Acceptability of Intervention
To establish acceptability, we will examine the % of participants scoring at or above the scale midpoint on the CSQ-8 (\>/= 70% as criteria for acceptability).
Time frame
Approximately 6 weeks following group program startOther outcomes
1
Sexual Satisfaction
A key exploratory aim of the proposed research is to determine the strength of within-group changes in satisfaction with sex life (subscale of the PROMIS-SexFS) for participants randomized to both groups, which will inform future trial design for a larger efficacy study.
Time frame
Approximately 6 weeks following group program startSponsors and contacts
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Massachusetts General Hospital
Lead sponsor
American Cancer Society, Inc.
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: