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

Mayo Clinic

Status: Completed

Conditions: Obesity-Related Malignant Neoplasm; Malignant Solid Neoplasm; Hematopoietic and Lymphoid System Neoplasm

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06030427

NCI-2023-06407 (Registry Identifier)

23-004890 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 1 patient group

Supportive care (virtual mindfulness and weight management)

Experimental group

Description:

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.

Treatment:

Other: Educational Intervention

Other: Internet-Based Intervention

Behavioral: Mindfulness Relaxation

Other: Medical Device Usage and Evaluation

Other: Health Promotion and Education

Other: Interview

Behavioral: Behavioral Dietary Intervention

Other: Questionnaire Administration

Other: Physical Performance Testing