Mind Body Program for Fear of Recurrence

• Sponsor: Beth Israel Deaconess Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT03695406
• Collaborator: (none)
• Enrollment: 23
• Location: 1
• Arm: 1
• Actual Duration (Months): 53
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer Survivors	Behavioral: Mind-Body Program for Fear of Recurrence	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 23 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Mind Body Program for Fear of Recurrence
• Actual Study Start Date: Aug 9, 2017
• Actual Primary Completion Date: Jun 30, 2019
• Actual Study Completion Date: Jan 7, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

Secondary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beth Israel Deaconess Medial Center	Boston	Massachusetts	United States	02215

Sponsors and Collaborators

• Beth Israel Deaconess Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gloria Y. Yeh, Associate Professor of Medicine, Beth Israel Deaconess Medical Center
• ClinicalTrials.gov Identifier: NCT03695406
• Other Study ID Numbers: 2017P000168
• First Posted: Oct 4, 2018
• Last Update Posted: Feb 1, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Recurrence

Study Results

No Results Posted as of Feb 1, 2022