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

M.D. Anderson Cancer Center

Status

Active, not recruiting

Conditions

Breast Carcinoma

Treatments

Other: Questionnaire Administration

Other: Physical Activity

Other: Best Practice

Behavioral: Nutrition Education

Device: FitBit

Behavioral: Behavioral Intervention

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT05132296

NCI-2021-08961 (Registry Identifier)

2020-1190 (Other Identifier)

UG1CA189824 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 2 patient groups

GROUP I (CLIP)

Experimental group

Description:

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).

Treatment: