Mind-Body Sexual Well-Being Program for Female GI Cancer Survivors

September 2, 2026 updated by: Lucy Finkelstein-Fox, PhD, Massachusetts General Hospital

Refining a Mind-Body Sexual Well-Being Program for Female GI Cancer Survivors

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The primary objective of this protocol is to iteratively refine and pilot test a novel mind-body sexual well-being intervention that investigators 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 the investigators 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), participants will complete electronic informed consent (including HIPAA authorization for access to relevant medical information in the EHR) prior to initiation of study procedures. Participants will then be invited to attend approximately 6 weeks of group-based sessions, lasting for approximately 90 minutes and including content related to mind-body medicine and complementary medical resources relevant to survivors' sexual well-being. To help investigators further refine the sexual well-being program for the next phase of the study, investigators will ask participants to complete brief (approximately 30 minute) survey batteries via REDCap at baseline and after the 6-session program, including assessments of intervention feasibility and acceptability as well as relevant psychosocial outcomes.

For Phase 2 (Randomized Pilot Trial), participants will complete electronic informed consent (including HIPAA authorization for access to relevant medical information in the EHR) prior to initiation of study procedures. Participants will then be randomized into groups (mind-body intervention groups vs. enhanced usual care control (EUCC)).

Participants randomized to EUCC will not receive any components of the mind-body group intervention. As part of this condition, participants will receive the current standard of care for patients at MGH and additionally receive a standard resource sheet to ensure that all participants receive a basic level of information specific to sexuality in cancer survivorship. As part of routine study assessments, investigators will measure EUCC participants' level of engagement with the Sexual Health Clinic and other supportive resources.

Participants in the mind-body group intervention arm will receive the same educational information about available sexual health resources as the EUCC participants to ensure equal familiarity with supportive resources within and outside of MGH. Participants randomized to receive the mind-body group intervention will also participate in a similar approximately 6-week group-based mind-body sexual well-being program as is described for Aim 1.

Just as for Aim 1, to inform ongoing intervention refinement, investigators will ask all participants to complete brief (approximately 30 minute) survey batteries via REDCap at baseline and after the 6-session program, including items related to feasibility, acceptability, and relevant psychosocial outcomes. Investigators will only randomize participants after receiving a completed baseline survey; participants who do not complete the baseline survey will not be counted towards the total number enrolled in the study. To capture symptom change over a longer period, investigators will also ask participants to complete survey batteries at 3-month post-intervention follow-up.

Approximately 20 participants randomized to receive the novel mind-body group study intervention 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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 relationships, including changes that may be related to cancer diagnosis and treatment
  7. Access to an internet-connected device with video

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 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mind-Body Sexual Well-Being Group Intervention

Participants 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.
Behavioral: Mind-Body Group Intervention
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.
Active Comparator: Enhanced Usual Care Control (EUCC)
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 several high-quality sexual health resources currently available to them.
Behavioral: Enhanced Usual Care Control (EUCC)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability of Intervention
Time Frame: Approximately 6 weeks following group program start
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
Feasibility of Intervention
Time Frame: Approximately 6 weeks after the final 6-week group program begins
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sexual Satisfaction
Time Frame: Approximately 6 weeks following group program start
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.
Approximately 6 weeks following group program start

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

American Cancer Society, Inc.

Investigators

  • Principal Investigator: Lucy Finkelstein-Fox, PhD, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

June 1, 2029

Study Registration Dates

First Submitted

August 25, 2026

First Submitted That Met QC Criteria

August 25, 2026

First Posted (Actual)

August 31, 2026

Study Record Updates

Last Update Posted (Actual)

September 8, 2026

Last Update Submitted That Met QC Criteria

September 2, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 26-077
  • CSDG-23-1152971-01-CSCT (Other Grant/Funding Number: American Cancer Society)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Data can be shared no earlier than 1 year following the date of publication

IPD Sharing Access Criteria

Contact the Partners Innovations team

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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