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

NCT06331403 | Completed Results

• 1 other identifier: 24-009
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer; Anal Cancer; Sexual Dysfunction

Keywords

sexual well-being; women's health; colorectal cancer; anal cancer

Outcome Measures

Primary Outcomes (2)

• Feasibility of Intervention

  The primary feasibility metric will be program engagement, quantified as participant rates of intervention attendance (% attending at least 4 of 6 sessions). Given the preliminary, open pilot nature of this protocol, the investigators will not set a priori criteria to establish feasibility but will rather use these data to inform ongoing protocol refinement.

  Approximately 6 weeks after the final 6-week (up to N=2 groups) group program begins

• Acceptability of Intervention

  The primary intervention acceptability metric will be participant ratings of overall comfort with the group program (% rating comfort with the group sessions =\>4 on a single 1-5 Likert scale). Given the preliminary, open pilot nature of this protocol, the investigators will not set a priori criteria to establish acceptability but will rather use these data to inform ongoing protocol refinement.

  Approximately 6 weeks following group program start

Study Arms (1)

Mind-Body Sexual Well-Being Group Intervention

EXPERIMENTAL

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.

Behavioral: Mind-Body Group Intervention

Interventions

Mind-Body Group Intervention 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.

Mind-Body Sexual Well-Being Group Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

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 research study

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Harvard Medical School (HMS and HSDM): collaborator

Study Sites (1)

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Anus Neoplasms; Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Rectal Neoplasms; Anus Diseases; Genital Diseases; Urogenital Diseases

Results Point of Contact

• Title: Lucy Finkelstein-Fox, PhD
• Organization: Massachusetts General Hospital

lfinkelsteinfox@mgh.harvard.edu

617-726-6300

Study Officials

• Lucy Finkelstein-Fox, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychology

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: March 26, 2024
• Study Start: July 10, 2024
• Primary Completion: November 11, 2024
• Study Completion: January 6, 2025
• Last Updated: November 24, 2025
• Results First Posted: November 24, 2025

Record last verified: 2025-11

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

Locations

US (1)