Clinical trial NCT06030427: Virtual Mindfulness and Weight Management to Mitigate Risk of Relapse and Improve Wellbeing in Cancer Survivors
Official title: A Virtual Mindfulness and Weight Management Program for Those with Cancer Histories to Mitigate Risk of Relapse and Improve Wellbeing: a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hematopoietic and Lymphoid System Neoplasm
Malignant Solid Neoplasm
Obesity-Related Malignant Neoplasm
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-09-11
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: General anxiety disorder-7 (GAD-7)
timeFrame: Baseline; 12 weeks
measure: Patient Health Questionnaire (PHQ)-8
timeFrame: Baseline; 12 weeks
measure: Feasibility of virtual mindfulness and weight management program
timeFrame: 12 weeks
Secondary outcomes:
measure: Body weight
timeFrame: Baseline; 12 weeks
measure: Body composition parameter
timeFrame: Baseline; 12 weeks
measure: Daily activity levels - heart rate
timeFrame: Baseline; 12 weeks
measure: Daily activity levels - activity
timeFrame: Baseline; 12 weeks
Other outcomes:
Locations:
city: La Crosse
country: United States
facility: Mayo Clinic Health System-Franciscan Healthcare
state: Wisconsin
Study officials:
affiliation: Mayo Clinic Health System-Franciscan Healthcare
name: Lisa Howell, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: