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

NCT ID: NCT06030427

Last Updated: 2025-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-08

Study Completion Date

2024-01-02

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Behavioral Dietary Intervention

Intervention Type BEHAVIORAL

Participate in weight management program

Educational Intervention

Intervention Type OTHER

Receive patient education handouts

Health Promotion and Education

Intervention Type OTHER

View behavioral educational PowerPoint presentation

Internet-Based Intervention

Intervention Type OTHER

Complete virtual behavioral weight management with an integrated mindfulness component program

Interview

Intervention Type OTHER

Ancillary studies

Medical Device Usage and Evaluation

Intervention Type OTHER

Wear Fitbit

Mindfulness Relaxation

Intervention Type BEHAVIORAL

Complete mindfulness components

Physical Performance Testing

Intervention Type OTHER

Ancillary studies

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Behavioral Dietary Intervention

Participate in weight management program

Intervention Type BEHAVIORAL

Educational Intervention

Receive patient education handouts

Intervention Type OTHER

Health Promotion and Education

View behavioral educational PowerPoint presentation

Intervention Type OTHER

Internet-Based Intervention

Complete virtual behavioral weight management with an integrated mindfulness component program

Intervention Type OTHER

Interview

Ancillary studies

Intervention Type OTHER

Medical Device Usage and Evaluation

Wear Fitbit

Intervention Type OTHER

Mindfulness Relaxation

Complete mindfulness components

Intervention Type BEHAVIORAL

Physical Performance Testing

Ancillary studies

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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Education for Intervention Intervention by Education Intervention through Education Intervention, Educational MBSR Mindful Meditation Mindfulness Meditation Mindfulness-Based Stress Reduction Physical Fitness Testing Physical Function Testing

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lisa Howell, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic Health System-Franciscan Healthcare

Locations

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Mayo Clinic Health System-Franciscan Healthcare

La Crosse, Wisconsin, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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NCI-2023-06407

Identifier Type: REGISTRY

Identifier Source: secondary_id

23-004890

Identifier Type: OTHER

Identifier Source: secondary_id

23-004890

Identifier Type: -

Identifier Source: org_study_id

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