Mind-Body Sexual Well-Being Program for Female GI Cancer Survivors
Refining a Mind-Body Sexual Well-Being Program for Female GI Cancer Survivors
2 other identifiers
interventional
100
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 25, 2026
CompletedFirst Posted
Study publicly available on registry
August 31, 2026
CompletedStudy Start
First participant enrolled
October 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2029
September 8, 2026
August 1, 2026
2.7 years
August 25, 2026
September 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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).
Approximately 6 weeks after the final 6-week group program begins
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).
Approximately 6 weeks following group program start
Other Outcomes (1)
Sexual Satisfaction
Approximately 6 weeks following group program start
Study Arms (2)
Mind-Body Sexual Well-Being Group Intervention
EXPERIMENTALParticipants in the mind-body sexual well-being group intervention arm will participate in 6 weekly group sessions, delivered via videoconferencing, following enrollment. Group sessions will include content related to mind-body medicine (e.g., relaxation, mindfulness, self-compassion) applied to sexual well-being as well as educational information related to women's sexual well-being in cancer survivorship. Before and after completing the group program, participants will also complete brief self-assessment questionnaires. Participants in the mind-body group intervention arm will also receive the same educational information about available sexual health resources as the EUCC participants, to ensure equal familiarity with high-quality educational and supportive resources related to women's sexual well-being and cancer.
Enhanced Usual Care Control (EUCC)
ACTIVE COMPARATORParticipants 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 several high-quality sexual health resources currently available to them.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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)
- 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)
- Verbally endorse experiencing distressing changes to sexual health or intimate relationships, including changes that may be related to cancer diagnosis and treatment
- Access to an internet-connected device with video
You may not qualify if:
- 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).
- In addition, individuals who participate in Phase 1 of this protocol (open pilot trial) will not be eligible to participate in Phase 2 (pilot RCT). Investigators will not enroll the following special populations: adults unable to consent, individuals who are not yet adults (i.e., \< age 18), pregnant women, and prisoners.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Massachusetts General Hospitallead
- American Cancer Society, Inc.collaborator
Study Sites (1)
Mass General Brigham Cancer Institute
Boston, Massachusetts, 02114, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lucy Finkelstein-Fox, PhD
Massachusetts General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Psychology
Study Record Dates
First Submitted
August 25, 2026
First Posted
August 31, 2026
Study Start
October 1, 2026
Primary Completion (Estimated)
June 1, 2029
Study Completion (Estimated)
June 1, 2029
Last Updated
September 8, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication
- Access Criteria
- Contact the Partners Innovations team
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: lfinkelsteinfox@mgh.harvard.edu. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.