Clinical trial NCT04876599: Mind-body Resiliency Intervention for Fear of Cancer Recurrence
Official title: IN FOCUS: A Multimodal Mind-Body Intervention for Fear of Recurrence Among Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Coping Skills
Coping Behavior
Keywords: Cancer
Coping Skills
Coping Behavior
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2021-05-06
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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 outcomes:
measure: Feasibility: Retention Rate
timeFrame: Baseline to approximately 2 months
measure: Acceptability: 5 Item Measure of Enjoyableness, Convenience, Helpfulness, Odds of Future Use, and Overall Satisfaction
timeFrame: Baseline to approximately 2 months
Secondary outcomes:
measure: Fear of Cancer Recurrence
timeFrame: Baseline, approximately 2 months, approximately 5 months
measure: Resiliency
timeFrame: Baseline, approximately 2 months, approximately 5 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusett General Hospital Cancer Center
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Concord
country: United States
facility: Mass General at Emerson Hospital -- Bethke
state: Massachusetts
city: Danvers
country: United States
facility: Mass General/North Shore Cancer Center
state: Massachusetts
city: Newton
country: United States
facility: Newton-Wellesley Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Daniel L Hall, PhD
role: PRINCIPAL_INVESTIGATOR
References: