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Mind Body Program for Fear of Recurrence

Primary Purpose

Cancer Survivors

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mind-Body Program for Fear of Recurrence
Sponsored by
Beth Israel Deaconess Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cancer Survivors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beth Israel Deaconess Medial Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mind-Body Group Intervention

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
October 2, 2018
Last Updated
January 28, 2022
Sponsor
Beth Israel Deaconess Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03695406
Brief Title
Mind Body Program for Fear of Recurrence
Official Title
Mind Body Program for Fear of Recurrence
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
August 9, 2017 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
January 7, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Survivors

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mind-Body Group Intervention
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Mind-Body Program for Fear of Recurrence
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility (i.e., retention at initial follow-up assessment)
Description
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.
Time Frame
Through study completion (approximately 5 months)
Title
Acceptability
Description
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.
Time Frame
During intervention group sessions (approximately 2 months)
Secondary Outcome Measure Information:
Title
Fear of Cancer Recurrence
Description
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.
Time Frame
Baseline, 8 weeks (Post-intervention), 1 month follow-up, 3 months follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Beth Israel Deaconess Medial Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32818720
Citation
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.
Results Reference
derived

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Mind Body Program for Fear of Recurrence

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