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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for not_applicable

Timeline

Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

4 months study duration

First Submitted

Initial submission to the registry

August 28, 2023

Completed

11 days until next milestone

Study Start

First participant enrolled

September 8, 2023

Completed

3 days until next milestone

First Posted

Study publicly available on registry

September 11, 2023

Completed

4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2024

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2024

Completed

Last Updated

October 24, 2025

Status Verified

November 1, 2024

Enrollment Period

4 months

First QC Date

August 28, 2023

Last Update Submit

October 22, 2025

Conditions

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

Outcome Measures

Primary Outcomes (3)

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
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
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 Outcomes (4)

Body weight
Baseline; 12 weeks
Body composition parameter
Baseline; 12 weeks
Daily activity levels - heart rate
Baseline; 12 weeks
Daily activity levels - activity
Baseline; 12 weeks

Study Arms (1)

Supportive care (virtual mindfulness and weight management)

EXPERIMENTAL

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 InterventionOther: Educational InterventionOther: Health Promotion and EducationOther: Internet-Based InterventionOther: InterviewOther: Medical Device Usage and EvaluationBehavioral: Mindfulness RelaxationOther: Physical Performance TestingOther: Questionnaire Administration