Virtual Mindfulness and Weight Management to Mitigate Risk of Relapse and Improve Wellbeing in Cancer Survivors

Study Overview
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Brief Summary
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This clinical trial tests how well a virtual mindfulness and weight management program to mitigate risk of relapse and improve well being for obese cancer survivors in community practice and rural areas. Obesity has been linked to increased risk for certain kinds of cancer and is the second highest modifiable risk factor for cancer. It is also well documented that having a cancer diagnosis and treatment is a stressful experience. It is hoped that an addition of a 10-minute mindfulness-based stress reduction exercise to the virtual positive health habits group focused on weight management can improve wellbeing and distress. Virtual care options continue to extend the reach of medical providers to cancer survivors, particularly those in the rural setting. A virtual behavioral weight management program with an integrated mindfulness component may improve mood, coping strategies, stress management, and weight loss among community practice and rural obese cancer survivors.

Detailed Description
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PRIMARY OBJECTIVES: I. To assess if a 12-week virtual weight management program with a mindfulness component will improve well-being of obese cancer patients with a specific focus on self-reported measures of depression and anxiety. II. To assess if a mindfulness component added to the virtual behavioral weight management will promote weight loss, improve mood, and increase physical activity. OUTLINE: Patients participate in a virtual behavioral weight management program with an integrated mindfulness component consisting of 12, 75-minute virtual group sessions over 12 weeks to help improve mood, coping strategies, stress management, and weight loss. Patents also receive patient education handouts, view behavioral educational PowerPoint presentations over 30 minutes, and wear a Fitbit on study.

Official Title
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A Virtual Mindfulness and Weight Management Program for Those With Cancer Histories to Mitigate Risk of Relapse and Improve Wellbeing: A Feasibility Study

Conditions
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Hematopoietic and Lymphoid System Neoplasm, Malignant Solid Neoplasm, Obesity-Related Malignant Neoplasm

Intervention / Treatment
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* Behavioral: Behavioral Dietary Intervention
* Other: Educational Intervention
* Other: Health Promotion and Education
* Other: Internet-Based Intervention
* Other: Interview
* Other: Medical Device Usage and Evaluation
* Behavioral: Mindfulness Relaxation
* Other: Physical Performance Testing
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 or over Identified stage I, II, or III cancer in remission Body mass index (BMI) of 30 or greater English as a primary language Has access to a device with a camera (computer, tablet, or video capable phone) that has wifi and reliable internet access Exclusion Criteria: Unable to provide consent Eastern Cooperative Oncology Group (ECOG) performance status scale score of 3 or above

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supportive care (virtual mindfulness and weight management)<br>Patients participate in a virtual behavioral weight management program with an integrated mindfulness component consisting of 12, 75-minute virtual group sessions over 12 weeks to help improve mood, coping strategies, stress management, and weight loss. Patents also receive patient education handouts, view behavioral educational PowerPoint presentations over 30 minutes, and wear a Fitbit on study. | Behavioral: Behavioral Dietary Intervention<br>* Participate in weight management program<br>Other: Educational Intervention<br>* Receive patient education handouts<br>* Other names: Intervention, Educational;Other: Health Promotion and Education<br>* View behavioral educational PowerPoint presentation<br>Other: Internet-Based Intervention<br>* Complete virtual behavioral weight management with an integrated mindfulness component program<br>Other: Interview<br>* Ancillary studies<br>Other: Medical Device Usage and Evaluation<br>* Wear Fitbit<br>Behavioral: Mindfulness Relaxation<br>* Complete mindfulness components<br>* Other names: Mindfulness-Based Stress Reduction;Other: Physical Performance Testing<br>* Ancillary studies<br>* Other names: Physical Function Testing;Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General anxiety disorder-7 (GAD-7) | Assessed by change in GAD-7 scores from a total score for seven items ranges from 0 to 21: 0-4 (minimal anxiety); 5-9 (mild anxiety); 10-14 (moderate anxiety); 15-21 (severe anxiety). | Baseline; 12 weeks | 
| Patient Health Questionnaire (PHQ)-8 | Assessed by change in PHQ-8 scores, as measured by a total score of 4 items from 0-12: 0-2 (normal); 3-5 (mild depression); 6-8 (moderate depression); 9-12 (severe depression). | Baseline; 12 weeks | 
| Feasibility of virtual mindfulness and weight management program | Assessed by the extent to which participants adhere to the intervention. Will be quantified based on number of sessions attended out of a possible 12. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight | Assessed by change in body weight | Baseline; 12 weeks | 
| Body composition parameter | Will be assessed in a fasted state or 3 hour post meal by subjects standing on a scale without socks or shoes. | Baseline; 12 weeks | 
| Daily activity levels - heart rate | Will be assessed by heart rate monitoring as recorded by a wrist-worn accelerometer (Fitbit Inspire) | Baseline; 12 weeks | 
| Daily activity levels - activity | Will be assessed from data recorded by a wrist-worn accelerometer monitoring fitness activity. | Baseline; 12 weeks |