Massachusetts General Hospital
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).
The primary objective of this protocol is to iteratively refine and pilot test a novel mind-body sexual well-being intervention that we have developed in previous research (DF-HCC protocols #22-586, #24-009, and #24-281). This protocol will include 2 study phases, including a small open pilot trial (Phase 1) and a subsequent larger randomized pilot trial (Phase 2). This protocol builds on previous work conducted by our research team to develop a 6-week, group-based, mind-body sexual well-being program for female survivors of colorectal and anal cancer. For Phase 1 (Open Pilot Trial), particip…
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 relat…
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.
Participants 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.
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