Mobile-Health Delivery of Lifestyle Interventions for Women With Breast Cancer

Mobile-Health Delivery of Lifestyle Interventions for Women With Breast Cancer Multicenter Pilot Trial

This clinical trial aims to develop a lifestyle program to improve clinical outcomes in women with breast cancer who do not have a healthy diet, regular exercise habits, or ways to manage their stress well. The program will include support and counseling in healthy eating, physical activity, stress management and mindfulness, learning sleep hygiene techniques, and behavioral counseling in addition to social support. Developing a lifestyle program may help improve quality of life and encourage healthy lifestyle choices among patients diagnosed with breast cancer.

Study Overview

• Status: Recruiting
• Conditions: Breast Carcinoma
• Intervention / Treatment: Other: Questionnaire Administration; Behavioral: Behavioral Intervention; Device: FitBit; Behavioral: Nutrition Education; Other: Physical Activity; Other: Best Practice

Detailed Description

PRIMARY OBJECTIVE:

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lorezo Cohen, MD; Phone Number: (713) 745-4260; Email: lcohen@mdanderson.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • M D Anderson Cancer Center
      • Contact: Lorenzo Cohen, MD; Phone Number: 713-745-2668; Email: lcohen@mdanderson.org
      • Principal Investigator: Lorenzo Cohen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Women with stage I-III BCa scheduled to undergo radiation therapy (RT) or within the first 12 months of having completed primary treatment (they do not need to have undergone RT)
• 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:

• Have not completed chemotherapy; have a recurrent BCa diagnosis; another primary cancer diagnosis within past 5 years (not including non-melanoma skin cancers)
• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Other: Questionnaire Administration; Ancillary studies; Behavioral: Behavioral Intervention; Undergo behavioral counseling; Other Names: Behavior Conditioning Therapy; Behavior Modification; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Interventions; Behavioral Modification; Behavioral Therapy; Behavioral Treatment; Behavioral Treatments; Device: FitBit; Receive FitBit; Behavioral: Nutrition Education; Receive nutrition education; Other: Physical Activity; Undergo physical activity
Active Comparator: GROUP II (usual care); Patients have access to all usual care supportive services.	Other: Questionnaire Administration; Ancillary studies; Other: Best Practice; Receive usual care supportive services; Other Names: standard of care; standard therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess the feasibility of delivering a mobile, standardized, comprehensive lifestyle program in women with BCa.	The feasibility criteria will include consent rate (how many patients are consented in a period of time), adherence rate ( how many patients adhere to the program and finish it), and study retention rate ( how many patients that are consented stay with the program until the end/ low number of participants withdrawing from the study after consent).	up to 9 months after study baseline

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Lorenzo Cohen, MD, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• M D Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2021
• Primary Completion (Estimated): February 2, 2027
• Study Completion (Estimated): February 2, 2027

Study Registration Dates

• First Submitted: September 17, 2021
• First Submitted That Met QC Criteria: November 11, 2021
• First Posted (Actual): November 24, 2021

Study Record Updates

• Last Update Posted (Actual): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 2020-1190 (Other Identifier: M D Anderson Cancer Center); UG1CA189824 (U.S. NIH Grant/Contract); NCI-2021-08961 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No