IN FOCUS: A Multimodal Mind-Body Intervention for Fear of Recurrence Among Cancer Survivors
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cancer
- Sponsor
- Massachusetts General Hospital
- Enrollment
- 64
- Locations
- 5
- Primary Endpoint
- Acceptability: 5 Item Measure of Enjoyableness, Convenience, Helpfulness, Odds of Future Use, and Overall Satisfaction
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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
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.
Investigators
Daniel Hall
Principal Investigator
Massachusetts General Hospital
Eligibility Criteria
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
Outcomes
Primary Outcomes
Acceptability: 5 Item Measure of Enjoyableness, Convenience, Helpfulness, Odds of Future Use, and Overall Satisfaction
Time Frame: Baseline to approximately 2 months
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.
Feasibility: Retention Rate
Time Frame: Baseline to approximately 2 months
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.
Secondary Outcomes
- Resiliency(Baseline, approximately 2 months, approximately 5 months)
- Fear of Cancer Recurrence(Baseline, approximately 2 months, approximately 5 months)