Mobile-Health Delivery of Lifestyle Interventions for Women With Breast Cancer
NCT ID: NCT05132296
Last Updated: 2025-12-31
Study Results
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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ACTIVE_NOT_RECRUITING
NA
30 participants
INTERVENTIONAL
2021-05-21
2026-06-15
Brief Summary
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Detailed Description
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I. Assess the feasibility of delivering a mobile, standardized, comprehensive lifestyle program in women with breast cancer (BCa).
SECONDARY OBJECTIVES:
I. Determine whether the comprehensive lifestyle intervention program (CLIP) group has reduction in body mass index (BMI) and percent body fat and weight over time.
II. Determine whether the CLIP group has improved outcomes in anthropometric measures, dietary patterns, and fitness measures and patient-reported outcomes including quality of life (QOL), fatigue, sleep disturbances, mental health, social support, and mindfulness.
OUTLINE: Patients are randomized into 1 of 2 groups.
GROUP I: Patients undergo 60 minute sessions of nutrition education for 12 weeks and behavioral intervention 26 weeks. Patients receive FitBit and undergo physical activity for 30-60 minutes 5 days a week (aerobic activity) and 2 days a week (resistance training).
GROUP II: Patients have access to all usual care supportive services.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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GROUP I (CLIP)
Patients undergo 60 minute sessions of nutrition education for 12 weeks and behavioral intervention 26 weeks. Patients receive FitBit and undergo physical activity for 30-60 minutes 5 days a week (aerobic activity) and 2 days a week (resistance training).
Behavioral Intervention
Undergo behavioral counseling
FitBit
Receive FitBit
Nutrition Education
Receive nutrition education
Physical Activity
Undergo physical activity
Questionnaire Administration
Ancillary studies
GROUP II (usual care)
Patients have access to all usual care supportive services.
Best Practice
Receive usual care supportive services
Questionnaire Administration
Ancillary studies
Interventions
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Behavioral Intervention
Undergo behavioral counseling
Best Practice
Receive usual care supportive services
FitBit
Receive FitBit
Nutrition Education
Receive nutrition education
Physical Activity
Undergo physical activity
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Underwent chemotherapy and surgery
* Able to read, write, and speak English
* BMI of 25 or higher
* 18 years of age or older
* Oriented to person, place, and time
* Participants must meet at least two of the following criteria related to their lifestyle at the time of diagnosis:
* Consume less than 3 servings of fruit and vegetable/day
* Engage in less than 75 minutes of moderate/vigorous intensity activity per week, defined as anything that causes small increases in breathing or heart rate for a sustained amount of time (e.g., brisk walking, bicycling)
* Engage in a mind-body practice less than 4 times a month
* Access to internet connection
* Access to a tablet, laptop or computer
* Able to come to University of Texas (UT) MD Anderson or Wake Forest for blood collection
* Able to perform light physical activity. if any medical issues exist or arise that may limit performing physical activity, a medical release will be required
Exclusion Criteria
* Any major thought disorder (e.g., schizophrenia, dementia)
* Any major communication barriers that would preclude being able to complete the intervention (e.g., visually or hearing impaired)
* Poorly or uncontrolled diabetes in the opinion of the physician(s)
* Extreme mobility issues (e.g., unable to get in and out of a chair unassisted)
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Lorenzo Cohen, MD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Provided Documents
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Document Type: Informed Consent Form
Related Links
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M D Anderson Cancer Center
Other Identifiers
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NCI-2021-08961
Identifier Type: REGISTRY
Identifier Source: secondary_id
2020-1190
Identifier Type: OTHER
Identifier Source: secondary_id
2020-1190
Identifier Type: -
Identifier Source: org_study_id