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

NCT05132296 | Active Not Recruiting

• 3 other identifiers: 2020-1190NCI-2021-08961UG1CA189824
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Breast Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

GROUP I (CLIP)

EXPERIMENTAL

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: Behavioral Intervention; Device: FitBit; Behavioral: Nutrition Education; Other: Physical Activity; Other: Questionnaire Administration

GROUP II (usual care)

ACTIVE COMPARATOR

Patients have access to all usual care supportive services.

Other: Best Practice; Other: Questionnaire Administration

Interventions

FitBit DEVICE

Receive FitBit

GROUP I (CLIP)

Nutrition Education BEHAVIORAL

Receive nutrition education

GROUP I (CLIP)

Physical Activity OTHER

Undergo physical activity

GROUP I (CLIP)

Questionnaire Administration OTHER

Ancillary studies

GROUP I (CLIP); GROUP II (usual care)

Behavioral Intervention BEHAVIORAL

Undergo behavioral counseling

Also known as: Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy, Behavioral Interventions, Behavioral Modification, Behavioral Therapy, Behavioral Treatment, Behavioral Treatments

GROUP I (CLIP)

Best Practice OTHER

Receive usual care supportive services

Also known as: standard of care, standard therapy

GROUP II (usual care)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• M.D. Anderson Cancer Center: lead

Study Sites (2)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Behavior Therapy; Practice Guidelines as Topic; Standard of Care; Nutrition Assessment; Exercise

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Epidemiologic Measurements; Public Health; Environment and Public Health; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Lorenzo Cohen, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2021
• First Posted: November 24, 2021
• Study Start: May 21, 2021
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): June 15, 2026
• Last Updated: December 31, 2025

Record last verified: 2025-12

Locations

US (2)