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

Breast Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05132296
• Other study ID #: 2020-1190
• Secondary ID: NCI-2021-0896120
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 21, 2021
• Est. completion date: February 2, 2027

Study information

• Verified date: June 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: February 2, 2027
• Est. primary completion date: February 2, 2027
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Breast Carcinoma
• Breast Neoplasms

Intervention

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
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   M D Anderson Cancer Center