Mind-body Resiliency Intervention for Fear of Cancer Recurrence

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04876599
• Other study ID #: 21-090
• Status: Completed
• Phase: N/A
• Start date: July 9, 2021
• Est. completion date: August 31, 2023

Study information

• Verified date: October 2023
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: August 31, 2023
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Cancer
• Coping Behavior
• Coping Skills
• Recurrence

Intervention

Behavioral:
• IN FOCUS
Adapted Resiliency Group Intervention
• Usual Care
Referral to Virtual Group Support

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Massachusett General Hospital Cancer 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

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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