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Mind Body Program for Fear of Recurrence

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ClinicalTrials.gov Identifier: NCT03695406
Recruitment Status : Recruiting
First Posted : October 4, 2018
Last Update Posted : October 4, 2018
Sponsor:
Information provided by (Responsible Party):
Gloria Y. Yeh, 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.

Condition or disease Intervention/treatment Phase
Cancer Survivors Behavioral: Mind-Body Program for Fear of Recurrence Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
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 : August 9, 2017
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : April 14, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03695406


Contacts
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Contact: Daniel L Hall, PhD 6177548080 dlhall@bidmc.harvard.edu
Contact: Gloria Y Yeh, MD, MPH 6177541419 gyeh@bidmc.harvard.edu

Locations
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United States, Massachusetts
Beth Israel Deaconess Medial Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Daniel L Hall, PhD    617-754-1427    dlhall@bidmc.harvard.edu   
Sub-Investigator: Daniel L Hall, PhD         
Sponsors and Collaborators
Beth Israel Deaconess Medical Center

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Responsible Party: Gloria Y. Yeh, Associate Professor of Medicine, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT03695406     History of Changes
Other Study ID Numbers: 2017P000168
First Posted: October 4, 2018    Key Record Dates
Last Update Posted: October 4, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Recurrence
Disease Attributes
Pathologic Processes