Mind Body Program for Fear of Recurrence

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Gloria Y. Yeh，Beth Israel Deaconess Medical Center

Tracking Information

First Submitted Date ^ICMJE

October 2, 2018

First Posted Date ^ICMJE

October 4, 2018

Last Update Posted Date

October 4, 2018

Actual Study Start Date ^ICMJE

August 9, 2017

Estimated Primary Completion Date

June 30, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Feasibility[ 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.

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Fear of Cancer Recurrence[ Time Frame: 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 ≥13 indicates clinically-elevated FCR.

Descriptive Information

Brief Title ^ICMJE

Mind Body Program for Fear of Recurrence

Official Title ^ICMJE

Mind Body Program for Fear of Recurrence

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

Study Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation:
Intervention Model: Single Group Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Other

Condition ^ICMJE

Intervention ^ICMJE

Behavioral: Mind-Body Program for Fear of Recurrence
An adapted protocol of the Relaxation Response Resiliency Program, a manualized, group-based, multimodal mind body program. Protocol adaptation includes refinement of content and study procedures to target fear of cancer recurrence (FCR) among adult cancer survivors.

Study Arms

Experimental: Mind-Body Group Intervention

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

April 14, 2020

Estimated Primary Completion Date

June 30, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

Gloria Y. Yeh，Beth Israel Deaconess Medical Center

Study Sponsor ^ICMJE

Beth Israel Deaconess Medical Center

Collaborators ^ICMJE

Investigators ^ICMJE

PRS Account

Beth Israel Deaconess Medical Center

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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