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

January 30, 2024 updated by: Mayo Clinic

A Virtual Mindfulness and Weight Management Program for Those With Cancer Histories to Mitigate Risk of Relapse and Improve Wellbeing: A Feasibility Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Wisconsin
      • La Crosse, Wisconsin, United States, 54601
        • Recruiting
        • Mayo Clinic Health System-Franciscan Healthcare
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lisa Howell, Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Supportive care (virtual mindfulness and weight management)
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.
Other: Questionnaire Administration
Ancillary studies
Other: Interview
Ancillary studies
Other: Physical Performance Testing
Ancillary studies
Other Names:
  • Physical Fitness Testing
  • Physical Function Testing
Behavioral: Behavioral Dietary Intervention
Participate in weight management program
Other: Educational Intervention
Receive patient education handouts
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational
Other: Health Promotion and Education
View behavioral educational PowerPoint presentation
Other: Internet-Based Intervention
Complete virtual behavioral weight management with an integrated mindfulness component program
Other: Medical Device Usage and Evaluation
Wear Fitbit
Behavioral: Mindfulness Relaxation
Complete mindfulness components
Other Names:
  • MBSR
  • Mindfulness-Based Stress Reduction
  • Mindfulness Meditation
  • Mindful Meditation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
General anxiety disorder-7 (GAD-7)
Time Frame: 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).
Baseline; 12 weeks
Patient Health Questionnaire (PHQ)-8
Time Frame: 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).
Baseline; 12 weeks
Feasibility of virtual mindfulness and weight management program
Time Frame: 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.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body weight
Time Frame: Baseline; 12 weeks
Assessed by change in body weight
Baseline; 12 weeks
Body composition parameter
Time Frame: 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.
Baseline; 12 weeks
Daily activity levels - heart rate
Time Frame: Baseline; 12 weeks
Will be assessed by heart rate monitoring as recorded by a wrist-worn accelerometer (Fitbit Inspire)
Baseline; 12 weeks
Daily activity levels - activity
Time Frame: Baseline; 12 weeks
Will be assessed from data recorded by a wrist-worn accelerometer monitoring fitness activity.
Baseline; 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Lisa Howell, Ph.D., Mayo Clinic Health System-Franciscan Healthcare

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 8, 2023

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

August 28, 2023

First Submitted That Met QC Criteria

September 1, 2023

First Posted (Actual)

September 11, 2023

Study Record Updates

Last Update Posted (Estimated)

February 1, 2024

Last Update Submitted That Met QC Criteria

January 30, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-004890 (Other Identifier: Mayo Clinic Institutional Review Board)
  • NCI-2023-06407 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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