Mind-body Resiliency Intervention for Fear of Cancer Recurrence

Not Applicable

Completed

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.

Recruitment & Eligibility

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

Primary Outcome Measures

Name	Time	Method
Acceptability: 5 Item Measure of Enjoyableness, Convenience, Helpfulness, Odds of Future Use, and Overall Satisfaction	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	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 Outcome Measures

Name	Time	Method
Resiliency	Baseline, approximately 2 months, approximately 5 months	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.
Fear of Cancer Recurrence	Baseline, approximately 2 months, approximately 5 months	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.

Locations (5): 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
Newton-Wellesley Hospital
🇺🇸
Newton, Massachusetts, United States
Massachusett General Hospital Cancer Center
🇺🇸Boston, Massachusetts, United States