Mind-body Resiliency Intervention for Fear of Cancer Recurrence
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intervention (IN FOCUS) Participants will be randomly assigned and participate in approximately eight weekly virtual group sessions to learn mind-body, cognitive behavioral, and positive psychology skills. |
Behavioral: IN FOCUS
Adapted Resiliency Group Intervention
|
| Active Comparator: 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. |
Behavioral: Usual Care
Referral to Virtual Group Support
|
Outcome Measures
Primary Outcome Measures
- Feasibility: Retention Rate [Baseline to approximately 2 months]
The primary metric for assessing feasibility will be retention at the initial follow-up assessment (≥70%). 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 per session as well as per participant (e.g., ≥75% of intervention sessions attended), self-reported adherence to skills practice, interventionist fidelity, and survey completion within and across assessments. Exit interviews will use open-ended questions to assess the feasibility of attending virtual sessions.
- Acceptability: 5 item measure of enjoyableness, convenience, helpfulness, odds of future use, and overall satisfaction [Baseline to approximately 2 months]
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 or support group. A secondary acceptability metric will include themes generated from open-ended questions from exit interviews that assess participants' expectations, recommendations, and perceived changes in FOR and healthcare engagement. Exit interviews will also ask participants in the intervention about the acceptability of each mind-body skill taught (e.g., perceived benefits, challenges, barriers, any modifications made).
Secondary Outcome Measures
- Fear of Recurrence [Change from baseline to approximately 2 months, approximately 5 months]
Fear of recurrence (FOR) 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 FOR severity. To supplement this measure, open-ended questions in the exit interview will assess perceived changes in FOR.
- Healthcare Engagement [Change from baseline to approximately 2 months, approximately 5 months]
Healthcare engagement will be measured using an 18-item questionnaire adapted from the MEPS Cancer Experiences Questionnaire and MEPS Adult Self-Administered Questionnaire. We will assess type and frequency of clinic visits, frequency and duration of emergency department visits and in-hospitalizations, and cancer-related testing (e.g., biopsies, MRI's, CT). We will supplement these measures with health records data and open-ended questions in the exit interview assessing perceived changes in healthcare engagement.
- Health Behaviors [Change from baseline to approximately 2 months, approximately 5 months]
Health behaviors (i.e. physical activity, diet, smoking, etc.) will be assessed using a 28-item health behavior questionnaire.
- Coping Skills [Change from baseline to approximately 2 months, approximately 5 months]
Coping skills will be measured using the Measure of Current Status-Part A and Brief COPE. The MOCS-A is a 13-item self-report measure developed to assess participants' current self-perceived status on: the ability to relax at will, recognize stress-inducing situations, restructure maladaptive thoughts, and choose appropriate coping responses as needed. The Brief COPE is a 28-item self-report measure assessing a variety of coping styles. Subscale and total scores will be computed. To supplement these measures, exit interviews with participants in the intervention arm will ask about the acceptability of mind-body coping skills taught (e.g., perceived benefits, challenges, barriers, any modifications made).
- Mind-Body Practice [Change from baseline to approximately 2 months, approximately 5 months]
Mind-body practice will be assessed using a 17-item mind-body practice questionnaire. This questionnaire asks patients to report on their use, frequency of use, and perceived benefits from a variety of mind-body practices.
- Resiliency [Change from baseline to approximately 2 months, approximately 5 months]
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.
- Cancer Related Uncertainty [Change from baseline to approximately 2 months, approximately 5 months]
Cancer related uncertainty will be measured using the 22-item Mishel Uncertainty in Illness Scale-Survivor Version. Scores range from 22-110 with higher total scores reflecting greater cancer-related uncertainty.
- Uncertainty Tolerance [Change from baseline to approximately 2 months, approximately 5 months]
Uncertainty tolerance will be measured using the 12-item Intolerance of Uncertainty Scale-Short Form. Total scores range from 12-60, with higher scores indicating greater uncertainty. The measure also includes a prospective anxiety and inhibitory anxiety subscale, with higher scores on each subscale indicating greater anxiety.
- Positive Affect [Change from baseline to approximately 2 months, approximately 5 months]
Positive affect will be measured using the 10-item Positive and Negative Affect Schedule -Positive affect subscale. Total scores range from 10-50 with higher scores indicating greater positive affect.
- Anxiety and Depression [Change from baseline to approximately 2 months, approximately 5 months]
Anxiety and depression will be measured using the 4-item Patient Health Questionnaire. PHQ-4 total scores range from 0 to 12, with both an anxiety and depression subscale. Greater scores on each subscale indicate greater symptom severity.
- Worry [Change from baseline to approximately 2 months, approximately 5 months]
Worry will be measured using the 16-item Penn State Worry Questionnaire. Total scores range from 16-39, with higher scores indicating greater worry.
- Distress [Change from baseline to approximately 2 months, approximately 5 months]
Distress will be measured using a single item visual analog scale. Patients will be asked to rate their current level of distress on a scale from 0 (no distress) to 10 (very high distress).
- Health Anxiety [Change from baseline to approximately 2 months, approximately 5 months]
Health anxiety will be measured using the 14-item Short Health Anxiety Inventory- Health Anxiety subscale. Total scores range from 0 to 42 with higher scores indicating greater health anxiety.
- Expectations [Baseline]
Expectations will be assessed using a 2-item measure. Participants will be asked to rate on a scale of 1 (not at all useful) to 9 (very useful) how useful any behavioral treatment will be in improving their health. Participants will also be asked to rate on a scale of 0% to 100% how much improvement in their health they think will occur.
- COVID-19 Impacts [Change from baseline to approximately 2 months, approximately 5 months]
COVID-19 impacts will be assessed using a 5-item questionnaire adapted from NIH-DR2 and PhenX Toolkit survey items.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
History of non-metastatic, localized, or regional solid or blood malignancy(ies)
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Completion of primary cancer treatment (i.e., radiation, surgery, chemotherapy) and/or current use of long-term maintenance hormonal or biologic therapy
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Massachusett General Hospital Cancer Center | Boston | Massachusetts | United States | 02114 |
| 2 | Beth Israel Deaconess Medical Center | Boston | Massachusetts | United States | 02215 |
| 3 | Mass General at Emerson Hospital -- Bethke | Concord | Massachusetts | United States | 01742 |
| 4 | Mass General/North Shore Cancer Center | Danvers | Massachusetts | United States | 01923 |
| 5 | Newton-Wellesley Hospital | Newton | Massachusetts | United States | 02462 |
Sponsors and Collaborators
- Massachusetts General Hospital
- National Center for Complementary and Integrative Health (NCCIH)
Investigators
- Principal Investigator: Daniel L Hall, PhD, Massachusetts General Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 21-090