Open Pilot Trial of a Mind-Body Sexual Well-Being Intervention for Female GI Cancer Survivors

NCT ID: NCT06331403

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-10
• Study Completion Date: 2025-01-06

Brief 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.

Conditions

Colorectal Cancer; Anal Cancer; Sexual Dysfunction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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 to measure topics including satisfaction with sexuality, coping, loneliness, concern about body image, and stigma.

Group Type: EXPERIMENTAL

Mind-Body Group Intervention

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Harvard Medical School (HMS and HSDM)

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Lucy Finkelstein-Fox, PhD

Assistant Professor of Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lucy Finkelstein-Fox, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

24-009

Identifier Type: -

Identifier Source: org_study_id