Mind Body Program for Fear of Recurrence

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 Overview

• Status: Completed
• Conditions: Cancer Survivors
• Intervention / Treatment: Behavioral: Mind-Body Program for Fear of Recurrence

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medial Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mind-Body Group Intervention	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility (i.e., retention at initial follow-up assessment)	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.	Through study completion (approximately 5 months)
Acceptability	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.	During intervention group sessions (approximately 2 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fear of Cancer Recurrence	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.	Baseline, 8 weeks (Post-intervention), 1 month follow-up, 3 months follow-up

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center

Publications and helpful links

General Publications

• Hall DL, Park ER, Cheung T, Davis RB, Yeh GY. A Pilot Mind-Body Resiliency Intervention Targeting Fear of Recurrence among Cancer Survivors. J Psychosom Res. 2020 Aug 10;137:110215. doi: 10.1016/j.jpsychores.2020.110215. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2017
• Primary Completion (Actual): June 30, 2019
• Study Completion (Actual): January 7, 2022

Study Registration Dates

• First Submitted: October 2, 2018
• First Submitted That Met QC Criteria: October 2, 2018
• First Posted (Actual): October 4, 2018

Study Record Updates

• Last Update Posted (Actual): February 1, 2022
• Last Update Submitted That Met QC Criteria: January 28, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Recurrence
• Other Study ID Numbers: 2017P000168

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No