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Behavioral Intervention

Mind-Body Intervention for Female GI Cancer Survivors

N/A
Recruiting
Led By Lucy Finkelstein-Fox, PhD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Female sex
Aged 18 or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 6 weeks after the final 6-week (up to n=2 groups) group program begins
Awards & highlights

Summary

This trial aims to gather feedback on a new intervention for female colorectal and anal cancer survivors. Up to 20 participants will receive the intervention and provide feedback on its acceptability, feasibility, and perceived

Who is the study for?
This trial is for English-speaking women, aged 18 or older, who have completed initial treatment for colorectal or anal cancer at least 3 months prior. They must have received their cancer care from specific sites associated with MGH-CC in locations like Boston and Danvers.Check my eligibility
What is being tested?
The study tests a new mind-body group intervention designed to improve sexual well-being in female GI cancer survivors. Up to 20 participants will give feedback on the program's acceptability and perceived benefits, influencing future larger-scale trials.See study design
What are the potential side effects?
Since this is a mind-body intervention focusing on psychological support rather than medication, typical drug side effects are not expected. However, discussing sensitive topics may cause emotional discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am female.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 6 weeks after the final 6-week (up to n=2 groups) group program begins
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 6 weeks after the final 6-week (up to n=2 groups) group program begins for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Acceptability of Intervention
Feasibility of Intervention

Trial Design

1Treatment groups
Experimental Treatment
Group I: Mind-Body Sexual Well-Being Group InterventionExperimental Treatment1 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.

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,955 Previous Clinical Trials
13,212,658 Total Patients Enrolled
Harvard Medical School (HMS and HSDM)OTHER
197 Previous Clinical Trials
1,316,455 Total Patients Enrolled
Lucy Finkelstein-Fox, PhDPrincipal InvestigatorMassachusetts General Hospital
~13 spots leftby Apr 2025