Mind Body Program for Fear of Recurrence

Not Applicable

Completed

• Conditions: Cancer Survivors
• Interventions: Behavioral: Mind-Body Program for Fear of Recurrence

• Registration Number: NCT03695406
• Lead Sponsor: Beth Israel Deaconess Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-09
• Study First Submitted: 2018-10-02
• Study First Submitted QC: 2018-10-02
• Study First Posted: 2018-10-04
• Primary Completion: 2019-06-30
• Status Verified: 2022-01
• Study Completion: 2022-01-07
• Last Update Submitted: 2022-01-28
• Last Update Posted: 2022-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

1. Patients must have a history of breast, lung, colorectal, hematologic, prostate, melanoma, or gynecological cancer (by medical record and/or self-report)
2. Completion of primary cancer treatment (radiation, surgery, and/or chemotherapy) between 3 to 30 months ago
3. Ages 18 and older (by medical record and/or self-report)

Exclusion Criteria

1. Self-reported inability to speak and write in English
2. Concurrent participation in weekly, group-based psychosocial or mind-body programs
3. 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.
4. Inability to travel to necessary study visits
5. No e-mail address to access online assessments

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mind-Body Group Intervention	Mind-Body Program for Fear of Recurrence	-

Primary Outcome Measures

Name	Time	Method
Acceptability	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)	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 Outcome Measures

Name	Time	Method
Fear of Cancer Recurrence	Baseline, 8 weeks (Post-intervention), 1 month follow-up, 3 months follow-up	Fear of Cancer Recurrence Inventory. Validated self-report measure of fear of cancer recurrence. 42 items across 7 subscales (triggers, severity, psychological distress, coping strategies, functioning impairments, insight, and reassurance). Higher scores indicate more fear of recurrence. Severity subscale score ≥16 indicates elevated FCR.

Trial Locations

Locations (1)

Beth Israel Deaconess Medial Center; 🇺🇸 Boston, Massachusetts, United States