Symptoms and General Pathology

All Conditions

Recurrence

Disease Attributes

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

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.

IN FOCUS

Usual Care

Daniel L Hall, PhD

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.

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.

Mind-body Resiliency Intervention for Fear of Cancer Recurrence

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

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.

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.

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.

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.

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.

National Center for Complementary and Integrative Health (NCCIH)

Massachusetts General Hospital

Principal Investigator

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

IN FOCUS: Adapted Resiliency Group Intervention

Intervention (IN FOCUS)

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.

Usual Care: Referral to Virtual Group Support

Total

Age, Continuous

Sex: Female, Male

Alaska Native

Asian

Black or African American

Native Hawaiian or Other Pacific Islander

White

Other

Hispanic

Participants could be included in more than one Race/Ethnicity category/row.

Race/Ethnicity, Customized

All participants who consented and completed the baseline survey

Dr. Daniel Hall

Feasibility: Retention Rate

Enjoyableness

Convenience

Helpfulness

Odds of Future Skills Use

Overall Satisfaction

IN FOCUS participants who responded to the acceptability measure.

Acceptability Items

This acceptability metric was assessed within the intervention arm only.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Mind-body Resiliency Intervention for Fear of Cancer Recurrence	NCT04876599	Cancer Coping Skills Coping Behavior	IN FOCUS Usual Care	18 Years -	Massachusetts General Hospital
Mind-body Resiliency Intervention for Fear of Cancer Recurrence	NCT04876599	Cancer Coping Skills Coping Behavior	IN FOCUS Usual Care	18 Years -	Massachusetts General Hospital

Spots Global Cancer Trial Database for in focus

Every month we try and update this database with for in focus cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for in focus

Every month we try and update this database with for in focus cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for in focus cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.