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
|Condition or disease||Intervention/treatment||Phase|
|Cancer Survivors||Behavioral: Mind-Body Program for Fear of Recurrence||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|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.
- 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.
- 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.
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
|Contact: Daniel L Hall, PhDemail@example.com|
|Contact: Gloria Y Yeh, MD, MPHfirstname.lastname@example.org|
|United States, Massachusetts|
|Beth Israel Deaconess Medial Center||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Daniel L Hall, PhD 617-754-1427 email@example.com|
|Sub-Investigator: Daniel L Hall, PhD|