Mind-body Resiliency Intervention for Fear of Cancer Recurrence

Study Overview
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Brief Summary
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The purpose of this study is to test the feasibility of a virtual, group mind-body resiliency intervention adapted to target fear of recurrence (FOR) among cancer survivors.

Detailed Description
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This is a randomized pilot feasibility trial (1:1 intervention versus usual care; a referral to community-based cancer survivor support group) that will use mixed methods (quantitative and qualitative) to evaluate the feasibility, acceptability, and preliminary effects of a virtual, group mind-body resiliency intervention adapted to target fear of recurrence (IN FOCUS) among cancer survivors with clinically elevated fear of recurrence (N = approximately 64). Patient-reported outcomes on psychological and behavioral outcomes will be measured at T0 (baseline), T1 (post-intervention/approximately two months post-baseline), and T2 (three months post-intervention/approximately five months post-baseline). Exit interviews will be conducted after the T1 survey. Participants are expected to be in the study for approximately five months.

Official Title
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IN FOCUS: A Multimodal Mind-Body Intervention for Fear of Recurrence Among Cancer Survivors

Conditions
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Cancer, Coping Skills, Coping Behavior

Intervention / Treatment
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* Behavioral: IN FOCUS
* Behavioral: Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: History of non-metastatic, localized, or regional solid or blood malignancy(ies) Completion of primary cancer treatment (i.e., radiation, surgery, chemotherapy) and/or current use of long-term maintenance hormonal or biologic therapy Age ≥18 years Elevated fear of recurrence (FCRI severity score ≥16) MGB/BIDMC Medical Record Number (MRN) Exclusion Criteria: Self-reported inability to speak and write in English Undertreated serious mental illness as defined by history of suicidality, psychosis, and/or psychiatric hospitalization in the past year Inability to access technology and/or sufficient internet to participate virtual groups sessions

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention (IN FOCUS)<br>Participants will be randomly assigned and participate in eight weekly virtual group sessions to learn mind-body, cognitive behavioral, and positive psychology skills. | Behavioral: IN FOCUS<br>* Adapted Resiliency Group Intervention<br>|
| Active Comparator: Usual Care<br>Participants will be randomly assigned and receive usual care, which is a referral for virtual group supportive services for cancer survivors provided in the community. | Behavioral: Usual Care<br>* Referral to Virtual Group Support<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility: Retention Rate | The primary metric for assessing feasibility will be retention at the initial follow-up assessment (≥70% survey completion). For descriptive purposes, secondary exploratory metrics of feasibility will include reasons for ineligibility, refusal, or dropping out will be measured, as will rates of enrollment, ratio of screened-to-eligible, attendance (e.g., ≥75% of intervention sessions attended), self-reported adherence to relaxation skills practice, and interventionist fidelity. Exit interviews will use open-ended questions to assess the feasibility of attending virtual sessions. | Baseline to approximately 2 months | 
| Acceptability: 5 Item Measure of Enjoyableness, Convenience, Helpfulness, Odds of Future Use, and Overall Satisfaction | As a primary quantitative acceptability outcome, participants will be asked to rate the enjoyableness, convenience, helpfulness, odds of future use, and overall satisfaction (1=very low to 5=very high) of the intervention. | Baseline to approximately 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fear of Cancer Recurrence | Fear of cancer recurrence (FCR) severity will be measured using the 9-item Fear of Cancer Recurrence Inventory severity subscale. Scores range from 0-36 with higher scores indicating greater FCR severity. To supplement this measure, open-ended questions in the exit interview will assess perceived changes in FCR. | Baseline, approximately 2 months, approximately 5 months | 
| Resiliency | Resiliency will be measured using the 23-item Current Experiences Scale. Subscale scores and total scores (range from 0-115) will be computed, with higher scores indicating higher resiliency. | Baseline, approximately 2 months, approximately 5 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Coping Skills, Coping Behavior