NCT05132296

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Breast Carcinoma

Interventions

Type	Name	Description
BEHAVIORAL	Behavioral Intervention	Undergo behavioral counseling
OTHER	Best Practice	Receive usual care supportive services
DEVICE	FitBit	Receive FitBit
BEHAVIORAL	Nutrition Education	Receive nutrition education
OTHER	Physical Activity	Undergo physical activity
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2021-05-21
• Primary completion: 2026-06-15
• Completion: 2026-06-15
• First posted: 2021-11-24
• Last updated: 2025-12-31

Locations

2 sites across 1 country: United States