Hematopoietic and Lymphoid System Neoplasm, Malignant Solid Neoplasm, Obesity-Related Malignant Neoplasm
Conditions
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.
Interventions
BEHAVIORALBehavioral Dietary Intervention
Participate in weight management program
OTHEREducational Intervention
Receive patient education handouts
OTHERHealth Promotion and Education
View behavioral educational PowerPoint presentation
OTHERInternet-Based Intervention
Complete virtual behavioral weight management with an integrated mindfulness component program
OTHERInterview
Ancillary studies
OTHERMedical Device Usage and Evaluation
Wear Fitbit
BEHAVIORALMindfulness Relaxation
Complete mindfulness components
OTHERPhysical Performance Testing
Ancillary studies
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 - activity | Baseline; 12 weeks | Will be assessed from data recorded by a wrist-worn accelerometer monitoring fitness activity. |
| Body weight | Baseline; 12 weeks | Assessed by change in body weight |
| Daily activity levels - heart rate | Baseline; 12 weeks | Will be assessed by heart rate monitoring as recorded by a wrist-worn accelerometer (Fitbit Inspire) |
Countries
United States
Outcome results
None listed