Virtual Mindfulness and Weight Management to Mitigate Risk of Relapse and Improve Wellbeing in Cancer Survivors
- Conditions
- Malignant Solid NeoplasmObesity-Related Malignant NeoplasmHematopoietic and Lymphoid System Neoplasm
- Interventions
- Behavioral: Behavioral Dietary InterventionOther: Educational InterventionOther: Health Promotion and EducationOther: Internet-Based InterventionOther: InterviewOther: Medical Device Usage and EvaluationBehavioral: Mindfulness RelaxationOther: Physical Performance TestingOther: Questionnaire Administration
- Registration Number
- NCT06030427
- Lead Sponsor
- Mayo Clinic
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 19
- 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
- Unable to provide consent
- Eastern Cooperative Oncology Group (ECOG) performance status scale score of 3 or above
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Supportive care (virtual mindfulness and weight management) Health Promotion and Education 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. Supportive care (virtual mindfulness and weight management) Interview 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. Supportive care (virtual mindfulness and weight management) Physical Performance Testing 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. Supportive care (virtual mindfulness and weight management) Behavioral Dietary Intervention 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. Supportive care (virtual mindfulness and weight management) Mindfulness Relaxation 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. Supportive care (virtual mindfulness and weight management) Educational Intervention 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. Supportive care (virtual mindfulness and weight management) Internet-Based Intervention 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. Supportive care (virtual mindfulness and weight management) Medical Device Usage and Evaluation 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. Supportive care (virtual mindfulness and weight management) Questionnaire Administration 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.
- Primary Outcome Measures
Name Time Method General anxiety disorder-7 (GAD-7) Baseline; 12 weeks 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).
Patient Health Questionnaire (PHQ)-8 Baseline; 12 weeks 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).
Feasibility of virtual mindfulness and weight management program 12 weeks 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.
- Secondary Outcome Measures
Name Time Method Body weight Baseline; 12 weeks Assessed by change in body weight
Body composition parameter Baseline; 12 weeks Will be assessed in a fasted state or 3 hour post meal by subjects standing on a scale without socks or shoes.
Daily activity levels - heart rate Baseline; 12 weeks Will be assessed by heart rate monitoring as recorded by a wrist-worn accelerometer (Fitbit Inspire)
Daily activity levels - activity Baseline; 12 weeks Will be assessed from data recorded by a wrist-worn accelerometer monitoring fitness activity.
Trial Locations
- Locations (1)
Mayo Clinic Health System-Franciscan Healthcare
🇺🇸La Crosse, Wisconsin, United States