NCT02387671

Weight Management Among Breast Cancer Survivors

Evaluation of mHealth Counseling for Lifestyle Behaviors Among Breast Cancer Survivors

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Boston Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Body Weight

Interventions

Type	Name	Description
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.
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.
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.

Timeline

• Start date: 2015-02-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2015-03-13
• Last updated: 2016-07-01

Locations

1 site across 1 country: United States