Mind-body Resiliency Intervention for Fear of Cancer Recurrence
IN FOCUS: A Multimodal Mind-Body Intervention for Fear of Recurrence Among Cancer Survivors
1 other identifier
interventional
64
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable cancer
Started Jul 2021
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 3, 2021
CompletedFirst Posted
Study publicly available on registry
May 6, 2021
CompletedStudy Start
First participant enrolled
July 9, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2023
CompletedResults Posted
Study results publicly available
October 12, 2023
CompletedOctober 12, 2023
October 1, 2023
1.1 years
May 3, 2021
August 18, 2023
October 10, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
Fear of Cancer Recurrence
Baseline, approximately 2 months, approximately 5 months
Resiliency
Baseline, approximately 2 months, approximately 5 months
Study Arms (2)
Intervention (IN FOCUS)
EXPERIMENTALParticipants will be randomly assigned and participate in eight weekly virtual group sessions to learn mind-body, cognitive behavioral, and positive psychology skills.
Usual Care
ACTIVE COMPARATORParticipants will be randomly assigned and receive usual care, which is a referral for virtual group supportive services for cancer survivors provided in the community.
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Massachusett General Hospital Cancer Center
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Mass General at Emerson Hospital -- Bethke
Concord, Massachusetts, 01742, United States
Mass General/North Shore Cancer Center
Danvers, Massachusetts, 01923, United States
Newton-Wellesley Hospital
Newton, Massachusetts, 02462, United States
Related Publications (1)
Christie AJ, Bolden C, Park ER, Yeh GY, O'Cleirigh C, Peppercorn J, Denninger JW, Hirschberg AM, Lee H, Markwart M, Siefring E, Mizrach HR, Bullock AJ, Hall DL. Managing, not lessening, uncertainty: a novel mind-body intervention for fear of cancer recurrence. J Cancer Surviv. 2025 Sep 1. doi: 10.1007/s11764-025-01886-2. Online ahead of print.
PMID: 40887510DERIVED
MeSH Terms
Conditions
Results Point of Contact
- Title
- Dr. Daniel Hall
- Organization
- Massachusetts General Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel L Hall, PhD
Massachusetts General Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 3, 2021
First Posted
May 6, 2021
Study Start
July 9, 2021
Primary Completion
August 31, 2022
Study Completion
August 31, 2023
Last Updated
October 12, 2023
Results First Posted
October 12, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication
- Access Criteria
- Contact the Partners Innovations team at http://www.partners.org/innovation
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: Daniel L. Hall, PhD (hall@mgh.harvard.edu). The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.