Clinical trial NCT02387671: Weight Management Among Breast Cancer Survivors
Official title: Evaluation of mHealth Counseling for Lifestyle Behaviors Among Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Weight
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: Boston University
First posted: 2015-03-13
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Body Weight
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Assistant Professor
name: Lisa Quintiliani, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.