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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
64
Adapted Resiliency Group Intervention
Referral to Virtual Group Support
Massachusett General Hospital Cancer Center
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Mass General at Emerson Hospital -- Bethke
Concord, Massachusetts, United States
Mass General/North Shore Cancer Center
Danvers, Massachusetts, United States
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.
Time frame: 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.
Time frame: Baseline to approximately 2 months
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.
Time frame: 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.
Time frame: Baseline, approximately 2 months, approximately 5 months
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Newton-Wellesley Hospital
Newton, Massachusetts, United States