eHealth Weight Loss Program in African American Breast Cancer Survivors
Condition: Cancer Survivor; Stage IA Breast Cancer; Stage IB Breast Cancer; Stage IIA Breast Cancer; Stage IIB Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer; Stage 0 Breast Cancer
MeSH terms: Breast Neoplasms; Breast Carcinoma In Situ; Weight Loss
Study type: Interventional

Summary: 
      This randomized pilot clinical trial studies how well a virtual weight loss program
      (SparkPeople) works in helping female African American breast cancer survivors maintain a
      healthy weight. Many patients with breast cancer are overweight or gain weight after
      diagnosis. SparkPeople is a free web-based weight loss program that features educational and
      motivational articles and videos, self-monitoring tools, incentives, social support
      communities (including discussion forums, teams, challenges, and expert blogs), and options
      for content to be delivered to members' email. It is a comprehensive program that includes
      advice on diet, physical activity, and behavioral strategies (such as self-monitoring diet
      and exercise), and emphasizes safe weight loss and receiving medical attention regularly when
      needed. A web-based program such as SparkPeople may help breast cancer survivors maintain a
      healthy weight, which may reduce the risk of cancer returning and patient fatigue, and
      improve patient quality of life.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. Determine feasibility of using a free online commercial weight loss program (SparkPeople)
      in African-American (AA) breast cancer survivors, as measured by: 1) Accrual: percent (%)
      patients recruited and completing baseline assessments; 2) Study retention: % patients
      completing 6 month follow-up assessment; 3) Intervention adherence and sustainability
      (measured at 3, 6, 12 months): a) use of website- number of log-ins, time spent, and use of
      features such as food diaries, joining teams, posting on message boards (provided by
      SparkPeople); b) use of Fitbit monitor- % patients who wore the monitor and synced data; c)
      satisfaction (e.g., ease of use of website, usefulness of content, extra training and support
      needed) and barriers to participation (e.g., lack of computer access, lack of skills, time,
      interest, etc.).

      SECONDARY OBJECTIVES:

      I. Collect preliminary data on effect sizes of changes in our outcomes and potential
      mediators associated with the use of the online weight loss program.

      OUTLINE: Patients are randomized to 1 of 2 groups.

      All patients receive a handout of their personalized goals for weight loss, diet, and
      physical activity, with instructions to proceed slowly and as tolerated. Patients also wear a
      Fitbit monitoring device to monitor physical activity levels daily.

      GROUP I: Patients receive one 30-minute session with the research assistant for training on
      how to use the SparkPeople website, and may request additional training if needed. Patients
      are instructed to self-monitor their diet at least weekly using SparkPeople and physical
      activity levels daily using the Fitbit monitoring device, which integrates with the
      SparkPeople program. Patients receive weekly motivational reminders to log into the website
      for 3 months via email, text, or phone, based on patient preference (active phase). Patients
      then enter the maintenance phase for an additional 3 months without reminders.

      GROUP II: Patients receive the weight loss handout and a Fitbit health monitoring device and
      proceed with their usual life. After 6 months, patients receive the SparkPeople treatment as
      in Group I.
    

Intervention name(s): Behavioral Dietary Intervention; Exercise Intervention; Activity Monitoring Device
Intervention type(s): Behavioral; Behavioral; Device
Intervention description(s): Use SparkPeople web-based program; Use Fitbit monitor and SparkPeople web-based program; Wear Fitbit activity monitoring device
Other intervention name(s): Monitor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care