Mind Body Program for Fear of Recurrence
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 23
- Locations
- 2
- Primary Endpoint
- Acceptability
Study Overview
Brief Summary
This is a pilot feasibility study of a group-based, mind body intervention for managing stress and fear of recurrence and promoting resiliency among adult cancer survivors.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients must have a history of breast, lung, colorectal, hematologic, prostate, melanoma, or gynecological cancer (by medical record and/or self-report)
- •Completion of primary cancer treatment (radiation, surgery, and/or chemotherapy) between 3 to 30 months ago
- •Ages 18 and older (by medical record and/or self-report)
Exclusion Criteria
- •Self-reported inability to speak and write in English
- •Concurrent participation in weekly, group-based psychosocial or mind-body programs
- •Serious mental illness (by medical record and/or self-report) as defined by history of suicidality, psychosis, and/or psychiatric hospitalization in the past year.
- •Inability to travel to necessary study visits
- •No e-mail address to access online assessments
Outcomes
Primary Outcomes
Acceptability
Time Frame: During intervention group sessions (approximately 2 months)
The primary metric for assessing Acceptability will be a five-item, investigator developed self-report questionnaire. Following each study session, participants will be asked to rate (1=not at all to 5=very much) the enjoyableness, convenience, helpfulness, relevancy, odds of future use, and overall satisfaction of the session.
Feasibility (i.e., retention at initial follow-up assessment)
Time Frame: Through study completion (approximately 5 months)
The primary metric for assessing Feasibility will be retention at the initial follow-up assessment. Reasons for ineligibility, refusal, or dropping out will be measured.
Secondary Outcomes
- Fear of Cancer Recurrence(Baseline, 8 weeks (Post-intervention), 1 month follow-up, 3 months follow-up)
Investigators
Gloria Y. Yeh
Associate Professor of Medicine
Beth Israel Deaconess Medical Center