eHealth Weight Loss Program in African American Breast Cancer Survivors

Study Overview
=================
Brief 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.

Official Title
-----------------
Virtual Weight Loss Program for African-American Breast Cancer Survivors

Conditions
-----------------
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

Intervention / Treatment
-----------------
* Behavioral: Behavioral Dietary Intervention
* Behavioral: Exercise Intervention
* Device: Activity Monitoring Device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have evidence of histologically confirmed breast cancer, stage 0, I, II or III, and be at least 2 years post diagnosis Patient is self-identified as African-American Patient is overweight or obese (body mass index [BMI] >= 25 kg/m^2) Patient is able to understand and read English Patient must have home internet or smartphone access Patient must give informed consent for this new study Exclusion Criteria: Patient has a serious medical condition (e.g., stroke, liver or renal failure, congestive heart failure, myocardial infarction or cardiac surgery in past year, angina pectoris) that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator Patient has serious psychiatric condition (e.g., bipolar disorder, schizophrenia or other psychosis, bulimia or anorexia nervosa, suicide attempt within 6 months or current active suicidal ideation) that would compromise the patient's ability to complete the study, at the discretion of the investigator Patient has severe disabilities limiting moderate physical activity, such as severe orthopedic conditions Patient is planning major surgery within the next 6 months Patient is taking medications or supplements for weight loss currently or within the past 3 months Patient has successfully lost 5% of body weight in the previous 6 months or has had bariatric surgery Patient is pregnant, breastfeeding, has given birth within the last 3 months or planning pregnancy within the next 12 months; if participant becomes pregnant during the course of the study, she will be removed from further participation Patient is anticipating leaving the area within the next 12 months

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I (SparkPeople program)<br>Participants receive one 30-minute session with the research assistant for training on how to use the SparkPeople website, and they may request additional training if needed. Participants are instructed to self-monitor their diet at least weekly using the SparkPeople tool, and to self-monitor their activity daily using the Fitbit monitoring device. Participants receive weekly motivational reminders to log into the website for 3 months via email, text, or phone, based on patient preference (active phase). Participants then enter the maintenance phase for 3 months without reminders. All participants answer survey questions on quality of life and social cognitive theory variables and undergo anthropometric measurements at baseline, 3, and 6 months. | Behavioral: Behavioral Dietary Intervention<br>* Use SparkPeople web-based program<br>Behavioral: Exercise Intervention<br>* Use Fitbit monitor and SparkPeople web-based program<br>Device: Activity Monitoring Device<br>* Wear Fitbit activity monitoring device<br>* Other names: Monitor;|
| Active Comparator: Group II (wait list)<br>Participants receive the weight loss handout and a Fitbit activity monitoring device and proceed with their usual life. After 6 months, patients receive the SparkPeople treatment as in Group I. All participants answer survey questions on quality of life and social cognitive theory variables and undergo anthropometric measurements at baseline, 3 and 6 months. | Device: Activity Monitoring Device<br>* Wear Fitbit activity monitoring device<br>* Other names: Monitor;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment Rate | Number of eligible participants who were enrolled and randomly assigned. Feasibility is defined as >= 75% recruitment rate. | 12 months | 
| Retention Rate | Number of participants completing study. Feasibility will be defined as >= 80% retention rate. | 6 months | 
| Adherence to SparkPeople- Logged in | average number of days logged per week in to SparkPeople website | 0-3 months after intervention | 
| Adherence to SparkPeople- Logged in | Average number of days per week logged in to SparkPeople website | 4-6 months after intervention | 
| Adherence to SparkPeople- Logged Food | Average number of days per week logged food into SparkPeople | 0-3 months after intervention | 
| Adherence to SparkPeople- Logged Food | Average number of days per week logged food into SparkPeople | 4-6 months after intervention | 
| Acceptability of SparkPeople | Usefulness of SparkPeople website on 1 (not useful at all) to 4 (very useful) scale | 0-3 months after intervention | 
| Acceptability of SparkPeople | Usefulness of SparkPeople website on 1 (not useful at all) to 4 (very useful) scale | 4-6 months after intervention | 
| Adherence to Fitbit | average days used Fitbit per week | 0-3 months after intervention | 
| Adherence to Fitbit | average days used Fitbit per week | 4-6 months after intervention | 
| Acceptability of Fitbit | Usefulness of Fitbit, rated on 1 (not useful at all) to 4 (very useful) scale | 0-3 months after intervention | 
| Acceptability of Fitbit | Usefulness of Fitbit, rated on 1 (not useful at all) to 4 (very useful) scale | 4-6 months after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Weight | Change in weight from baseline | baseline and 3 months | 
| Change in Weight | Change in weight from baseline | baseline and 6 months | 
| Change in Waist Circumference | Change in waist circumference from baseline | baseline and 3 months | 
| Change in Waist Circumference | Change in waist circumference from baseline | baseline and 6 months | 
| Change in Caloric Intake | Changes in caloric intake per day, measured by 24-hour recall | baseline and 3 months | 
| Change in Caloric Intake | Changes in caloric intake per day, measured by 24-hour recall | baseline and 6 months | 
| Change in Physical Activity | change in average number of steps per day measured using Fitbit monitor | baseline and 3 months | 
| Change in Physical Activity | change in average number of steps per day measured using Fitbit monitor | baseline and 6 months | 
| Cardiopulmonary Fitness | change in fitness, measured by the 6-minute walk test | baseline and 3 months | 
| Cardiopulmonary Fitness | change in fitness, measured by the 6-minute walk test | baseline and 6 months | 
| Change in Quality of Life | measured using Quality of Life in Adult Cancer Survivors Scale (minimum 65, maximum 257); higher scores mean worse quality of life | baseline and 3 months | 
| Change in Quality of Life | measured using Quality of Life in Adult Cancer Survivors Scale (minimum 65, maximum 257); higher scores mean worse quality of life | baseline and 6 months | 
| Self-efficacy, Eating Healthy Foods | change in self-efficacy, eating healthy foods, measured with Health Beliefs Survey, scale range 0 (certain I cannot) to 100 (certain I can) | baseline and 3 months | 
| Self-efficacy, Eating Healthy Foods | change in self-efficacy, eating healthy foods, measured with Health Beliefs Survey, scale range 0 (certain I cannot) to 100 (certain I can) | baseline and 6 months | 
| Social Support for Healthy Nutrition | change in social support for healthy nutrition, measured by Health Beliefs Survey, scale range 1 (strongly disagree) to 5 (strongly agree); a higher number, e.g., 5 (strongly agree) is the more favorable outcome | baseline and 3 months | 
| Social Support for Healthy Nutrition | change in social support for healthy nutrition, measured by Health Beliefs Survey, scale range 1 (strongly disagree) to 5 (strongly agree); a higher number, e.g., 5 (strongly agree) is the more favorable outcome | baseline and 6 months |