Mind-body Resiliency Intervention for Fear of Cancer Recurrence

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-09

Study Completion Date

2023-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cancer Coping Skills Coping Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

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Intervention (IN FOCUS)

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

Group Type EXPERIMENTAL

IN FOCUS

Intervention Type BEHAVIORAL

Adapted Resiliency Group Intervention

Usual Care

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.

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type BEHAVIORAL

Referral to Virtual Group Support

Interventions

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IN FOCUS

Adapted Resiliency Group Intervention

Intervention Type BEHAVIORAL

Usual Care

Referral to Virtual Group Support

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No