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

No Placebo-Only Group

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 6 weeks after the final 6-week (up to n=2 groups) group program begins

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acceptability of Intervention

Feasibility of Intervention

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 2Eligibility criteria met