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

Primary Purpose

Breast Carcinoma

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Behavioral Intervention

Best Practice

FitBit

Nutrition Education

Physical Activity

Questionnaire Administration

About this trial

This is an interventional supportive care trial for Breast Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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)

Sites / Locations

M D Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

GROUP I (CLIP)

GROUP II (usual care)

Arm 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).

Patients have access to all usual care supportive services.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

NCT ID

NCT05132296

First Posted

September 17, 2021

Last Updated

March 23, 2023

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT05132296

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 21, 2021 (Actual)

Primary Completion Date

November 30, 2023 (Anticipated)

Study Completion Date

November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Carcinoma

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

GROUP I (CLIP)

Arm Type

Experimental

Arm Description

Arm Title

GROUP II (usual care)

Arm Type

Active Comparator

Arm Description

Patients have access to all usual care supportive services.

Intervention Type

Behavioral

Intervention Name(s)

Behavioral Intervention

Other Intervention Name(s)

Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy, Behavioral Interventions, Behavioral Modification, Behavioral Therapy, Behavioral Treatment, Behavioral Treatments

Intervention Description

Undergo behavioral counseling

Intervention Type

Other

Intervention Name(s)

Best Practice

Other Intervention Name(s)

standard of care, standard therapy

Intervention Description

Receive usual care supportive services

Intervention Type

Device

Intervention Name(s)

FitBit

Intervention Description

Receive FitBit

Intervention Type

Behavioral

Intervention Name(s)

Nutrition Education

Intervention Description

Receive nutrition education

Intervention Type

Other

Intervention Name(s)

Physical Activity

Intervention Description

Undergo physical activity

Intervention Type

Other

Intervention Name(s)

Questionnaire Administration

Intervention Description

Ancillary studies

Primary Outcome Measure Information:

Title

Assess the feasibility of delivering a mobile, standardized, comprehensive lifestyle program in women with BCa.

Description

Time Frame

up to 9 months after study baseline

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lorezo Cohen, MD

Phone

(713) 745-4260

lcohen@mdanderson.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lorenzo Cohen, MD

Organizational Affiliation

M.D. Anderson Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

M D Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lorenzo Cohen, MD

Phone

713-745-2668

lcohen@mdanderson.org

First Name & Middle Initial & Last Name & Degree

Lorenzo Cohen, MD

12. IPD Sharing Statement

Links:

URL

http://www.mdanderson.org

Description

M D Anderson Cancer Center

Learn more about this trial

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

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