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OpenTrials
Completed

NCT Number: NCT06030427

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic Health System-Franciscan Healthcare

La Crosse, Wisconsin, 54601, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

behavioral dietary intervention

Behavioral

Participate in weight management program

Educational Intervention

Other

Receive patient education handouts

Other names: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Health Promotion and Education

Other

View behavioral educational PowerPoint presentation

Internet-Based Intervention

Other

Complete virtual behavioral weight management with an integrated mindfulness component program

interview

Other

Ancillary studies

Medical Device Usage and Evaluation

Other

Wear Fitbit

Mindfulness Relaxation

Behavioral

Complete mindfulness components

Other names: MBSR, Mindful Meditation, Mindfulness Meditation, Mindfulness-Based Stress Reduction

Physical Performance Testing

Other

Ancillary studies

Other names: Physical Fitness Testing, Physical Function Testing

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. 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).

  2. 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).

  3. 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.

Secondary outcomes

  1. Body weight

    Time frame: Baseline; 12 weeks

    Assessed by change in body weight

  2. 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.

  3. 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)

  4. Daily activity levels - activity

    Time frame: Baseline; 12 weeks

    Will be assessed from data recorded by a wrist-worn accelerometer monitoring fitness activity.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 11, 2023
Registry last updated
Oct 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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