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

Sponsor
Mayo Clinic (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06030427
Collaborator
(none)
36
Enrollment
1
Location
1
Arm
3.4
Anticipated Duration (Months)
10.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Behavioral Dietary Intervention
  • Other: Educational Intervention
  • Other: Health Promotion and Education
  • Other: Internet-Based Intervention
  • Other: Interview
  • Other: Medical Device Usage and Evaluation
  • Behavioral: Mindfulness Relaxation
  • Other: Physical Performance Testing
  • Other: Questionnaire Administration
 N/A

Detailed Description

PRIMARY OBJECTIVES:

  1. 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.

  2. 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 Design

Study Type:
Interventional
Anticipated Enrollment :
36 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
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
Anticipated Study Start Date :
Sep 21, 2023
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

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.

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: Interview
    Ancillary studies

    Other: Medical Device Usage and Evaluation
    Wear Fitbit

    Behavioral: Mindfulness Relaxation
    Complete mindfulness components
    Other Names:
  • MBSR
  • Mindful Meditation
  • Mindfulness Meditation
  • Mindfulness-Based Stress Reduction

    • Other: Physical Performance Testing
    Ancillary studies
    Other Names:
  • Physical Fitness Testing
  • Physical Function Testing

    • Other: Questionnaire Administration
    Ancillary studies

    Outcome Measures

    Primary Outcome Measures

    1. 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).

    2. 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).

    3. 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 Outcome Measures

    1. Body weight [Baseline; 12 weeks]

      Assessed by change in body weight

    2. 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.

    3. Daily activity levels [Baseline; 12 weeks]

      Will be assessed by heart rate monitoring as recorded by a wrist-worn accelerometer (Fitbit Inspire)

    4. Daily activity levels [Baseline; 12 weeks]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 18 or over

    • Identified stage I or stage II cancer in remission

    • Body mass index (BMI) of 30 or greater

    • Eastern Cooperative Oncology Group (ECOG) performance status scale score of 2 or less

    • 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

    • ECOG performance status scale score of 3 or above

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic Health System-Franciscan Healthcare La Crosse Wisconsin United States 54601

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT06030427
    Other Study ID Numbers:
    • 23-004890
    • NCI-2023-06407
    • 23-004890
    First Posted:
    Sep 11, 2023
    Last Update Posted:
    Sep 11, 2023
    Last Verified:
    Aug 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Neoplasms

    Study Results

    No Results Posted as of Sep 11, 2023