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

Malignant Solid Neoplasm Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06030427
• Other study ID #: 23-004890
• Secondary ID: NCI-2023-0640723
• Status: Recruiting
• Phase: N/A
• Start date: September 8, 2023
• Est. completion date: October 2024

Study information

• Verified date: January 2024
• Source: Mayo Clinic
• Contact: Moua Torgerson
• Phone: 608-392-9142
• Email: torgerson.moua[@]mayo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hematopoietic and Lymphoid System Neoplasm
• Malignant Solid Neoplasm
• Neoplasms
• Obesity-Related Malignant Neoplasm

Intervention

Behavioral:
• Behavioral Dietary Intervention
Participate in weight management program

Other:
• Educational Intervention
Receive patient education handouts
• Health Promotion and Education
View behavioral educational PowerPoint presentation
• Internet-Based Intervention
Complete virtual behavioral weight management with an integrated mindfulness component program
• Interview
Ancillary studies
• Medical Device Usage and Evaluation
Wear Fitbit

Behavioral:
• Mindfulness Relaxation
Complete mindfulness components

Other:
• Physical Performance Testing
Ancillary studies
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Mayo Clinic Health System-Franciscan Healthcare	La Crosse	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Body weight	Assessed by change in body weight	Baseline; 12 weeks
Secondary	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
Secondary	Daily activity levels - heart rate	Will be assessed by heart rate monitoring as recorded by a wrist-worn accelerometer (Fitbit Inspire)	Baseline; 12 weeks
Secondary	Daily activity levels - activity	Will be assessed from data recorded by a wrist-worn accelerometer monitoring fitness activity.	Baseline; 12 weeks

External Links

•   Mayo Clinic Clinical Trials