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Weight Management Among Breast Cancer Survivors

Primary Purpose

Body Weight

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Device: FitBit Flex wrist band
Device: FitBit Aria weight scale
Diet Intake Messages
Behavioral Counseling
Sponsored by
Boston Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Body Weight

Eligibility Criteria

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

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

Sites / Locations

  • Boston Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

mHealth Platform

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 12, 2015
Last Updated
June 29, 2016
Sponsor
Boston Medical Center
Collaborators
Boston University
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1. Study Identification

Unique Protocol Identification Number
NCT02387671
Brief Title
Weight Management Among Breast Cancer Survivors
Official Title
Evaluation of mHealth Counseling for Lifestyle Behaviors Among Breast Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Medical Center
Collaborators
Boston University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
mHealth Platform
Arm Type
Experimental
Arm Description
The primary interventions employed in the study are wifi enabled tracking devices, text message communications and behavioral counseling.
Intervention Type
Behavioral
Intervention Name(s)
Device: FitBit Flex wrist band
Other Intervention Name(s)
FitBit Flex™
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Device: FitBit Aria weight scale
Other Intervention Name(s)
FitBit Aria® wi-fi smart scale
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Diet Intake Messages
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Counseling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Body Weight
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Quintiliani, Ph.D.
Organizational Affiliation
Assistant Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28410174
Citation
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.
Results Reference
derived

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Weight Management Among Breast Cancer Survivors

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