Weight Management Among Breast Cancer Survivors

Evaluation of mHealth Counseling for Lifestyle Behaviors Among Breast Cancer Survivors

The long-term goal of this research is to develop, evaluate and implement effective mHealth technology interventions that improve cancer management outcomes by changing lifestyle behaviors among urban health- disparity facing populations. To accomplish this goal, the investigators will need to determine the feasibility and preliminary efficacy of an intervention in which breast cancer survivors receive counseling about lifestyle behaviors (weight, nutrition, and physical activity) from a health counselor trained in evidenced-based behavioral counseling methods.

Study Overview

• Status: Completed
• Conditions: Body Weight
• Intervention / Treatment: Behavioral: Device: FitBit Flex wrist band; Behavioral: Device: FitBit Aria weight scale; Behavioral: Diet Intake Messages; Behavioral: Behavioral Counseling

Detailed Description

Tremendous advances in detection and treatment of breast cancer have led to an increasingly large cohort of survivors focused on health promotion and reducing the risk of recurrence. While adjuvant therapy, such as hormone therapy, is often used to prevent cancer recurrence, modification of lifestyle is an effective tool to increase quality of life, prevent future cancer recurrence and increase long-term health. However, translating these recommendations into population-wide, inexpensive, sustainable programs for cancer survivors has to date proven largely unrealized. These programs are particularly needed in health disparity-facing populations (i.e., low socio-economic status and/or racial/ethnic minority groups) due to the high burden of cancer incidence and mortality they face. Limited translation is due to many factors including the complexity of lifestyle habits, high patient burden of many behavioral interventions, low levels of engagement and adherence to interventions, and the lack of integration of behavior change tools into daily lifestyles. In this context, there is great promise of tools that are mobile, simple, and embedded into daily life routines. The long-term goal of this research program is to develop, evaluate and implement effective mHealth technology interventions that improve cancer management outcomes by changing lifestyle behaviors among urban health- disparity facing populations.

The mHealth intervention for cancer survivors devised by the investigators consists of several components: 1) a commercially available smart phone app that captures patients' behavioral data (steps, sleep, weight) using devices (a FitBit and a FitBit scale), 2) text messages to participants to collect additional data (foods eaten, eating habits), and 3) phone sessions with a non-professionally trained health counselor about diet and physical activity behaviors.

The investigators propose to test the feasibility and preliminary outcomes on weight, behaviors, psychological factors as well as participant engagement in the intervention of our mHealth counseling intervention among 20 breast cancer survivors.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Willing to participate in intervention by sharing FitBit account information (log in/password) with study team
• 6 months or more since receiving cancer treatment including surgery, radiation, or chemotherapy (self-reported)
• 2 or more years post breast cancer diagnosis (self-reported)
• Current ownership of an iOS or Android based platform smartphone and home wifi
• Age 18 and above
• Ability to speak and read in English
• Overweight or obese (body mass index ≥ 25)
• Female

Exclusion Criteria:

• Medical conditions including dementia, active cancer, anorexia or any other condition in the opinion of the investigator makes the participant unsuitable for inclusion in the study
• Presence of a pacemaker or other internal medical device
• Those with contraindications for physical activity
• Pregnant women
• Inability to easily navigate programs on a smartphone

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: mHealth Platform; The primary interventions employed in the study are wifi enabled tracking devices, text message communications and behavioral counseling.

Behavioral: Device: FitBit Flex wrist band; Participants will track their daily steps walked and hours of sleep by wearing the FitBit Flex wrist band during the 8 week study period. The data collected from the wrist band will be synced to participants' FitBit smart phone application and monitored by the study team.; Other Names: FitBit Flex™; Behavioral: Device: FitBit Aria weight scale; Participants will record their daily body weight during the 8 week study period by stepping on the FitBit Aria weight scale. The data collected from the scale will be synced to participants' FitBit smart phone application accounts and monitored by the study team.; Other Names: FitBit Aria® wi-fi smart scale; Behavioral: Diet Intake Messages; The study team will send participants daily text messages regarding their dietary intake. Each message will contain five questions that yield a yes, or no response. Messages will be sent daily during the 8 week study period. Responses from the messages will be recorded and monitored by the study team to enhance the behavioral counseling intervention.; Behavioral: Behavioral Counseling; Participants will engage in four phone calls with the study counselor to discuss behavioral several topics (physical activity, sleep, fatigue & dietary patterns) and to reflect on their data recorded by the FitBit devices. The calls will take place on a bi-weekly basis. During the weeks between calls, the counselor will maintain contact with the participants through asynchronous text messages to monitor their progress in the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Weight	Participants will register daily body weight measurements during the 8-week study period. Weight will be recorded in units of pounds using the FitBit wifi compatable. All data will be synced to the participants' FitBit account and monitored by the study team.	8 weeks

Collaborators and Investigators

• Sponsor: Boston Medical Center
• Collaborators: Boston University
• Investigators: Principal Investigator: Lisa Quintiliani, Ph.D., Assistant Professor

Publications and helpful links

General Publications

• M Quintiliani L, Mann DM, Puputti M, Quinn E, Bowen DJ. Pilot and Feasibility Test of a Mobile Health-Supported Behavioral Counseling Intervention for Weight Management Among Breast Cancer Survivors. JMIR Cancer. 2016 May 9;2(1):e4. doi: 10.2196/cancer.5305.

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: February 12, 2015
• First Submitted That Met QC Criteria: March 12, 2015
• First Posted (Estimate): March 13, 2015

Study Record Updates

• Last Update Posted (Estimate): July 1, 2016
• Last Update Submitted That Met QC Criteria: June 29, 2016
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight
• Other Study ID Numbers: H-33650

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No