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Clinical Trials/NCT03695406
NCT03695406
Completed
Not Applicable

Mind Body Program for Fear of Recurrence

Beth Israel Deaconess Medical Center1 site in 1 country23 target enrollmentAugust 9, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cancer Survivors
Sponsor
Beth Israel Deaconess Medical Center
Enrollment
23
Locations
1
Primary Endpoint
Acceptability
Status
Completed
Last Updated
4 years ago

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.

Registry
clinicaltrials.gov
Start Date
August 9, 2017
End Date
January 7, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Gloria Y. Yeh

Associate Professor of Medicine

Beth Israel Deaconess Medical Center

Eligibility Criteria

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)

Study Sites (1)

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