Mind-body Resiliency Intervention for Fear of Cancer Recurrence

Mass General Brigham

Status: Completed

Conditions: Coping Behavior; Coping Skills; Cancer

Treatments: Behavioral: IN FOCUS; Behavioral: Usual Care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04876599

21-090

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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64 participants in 2 patient groups

Intervention (IN FOCUS)

Experimental group

Description:

Participants will be randomly assigned and participate in eight weekly virtual group sessions to learn mind-body, cognitive behavioral, and positive psychology skills.

Treatment:

Behavioral: IN FOCUS

Usual Care

Active Comparator group

Description:

Participants will be randomly assigned and receive usual care, which is a referral for virtual group supportive services for cancer survivors provided in the community.

Treatment:

Behavioral: Usual Care