Mind Body Program for Fear of Recurrence

Study Overview
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Brief Summary
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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.

Official Title
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Mind Body Program for Fear of Recurrence

Conditions
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Cancer Survivors

Intervention / Treatment
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* Behavioral: Mind-Body Program for Fear of Recurrence


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mind-Body Group Intervention<br> | Behavioral: Mind-Body Program for Fear of Recurrence<br>* 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.<br>|

What is the study measuring?
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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 |