Weight Management Among Breast Cancer Survivors
Evaluation of mHealth Counseling for Lifestyle Behaviors Among Breast Cancer Survivors
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2015
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 12, 2015
CompletedFirst Posted
Study publicly available on registry
March 13, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedJuly 1, 2016
January 1, 2015
5 months
February 12, 2015
June 29, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
mHealth Platform
EXPERIMENTALThe primary interventions employed in the study are wifi enabled tracking devices, text message communications and behavioral counseling.
Interventions
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.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- Willing to participate in intervention by sharing FitBit account information (log in/password) with study team
- months or more since receiving cancer treatment including surgery, radiation, or chemotherapy (self-reported)
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Boston Medical Centerlead
- Boston Universitycollaborator
Study Sites (1)
Boston Medical Center
Boston, Massachusetts, 02118, United States
Related Publications (1)
Quintiliani LM, 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 Jan-Jun;2(1):e4. doi: 10.2196/cancer.5305. Epub 2016 May 9.
PMID: 27761518DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lisa Quintiliani, Ph.D.
Assistant Professor
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 12, 2015
First Posted
March 13, 2015
Study Start
February 1, 2015
Primary Completion
July 1, 2015
Study Completion
July 1, 2015
Last Updated
July 1, 2016
Record last verified: 2015-01