Cancer Survivor, Stage 0 Breast Cancer, 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
Conditions
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.
Interventions
BEHAVIORALBehavioral Dietary Intervention
Use SparkPeople web-based program
BEHAVIORALExercise Intervention
Use Fitbit monitor and SparkPeople web-based program
DEVICEActivity Monitoring Device
Wear Fitbit activity monitoring device
Sponsors
National Cancer Institute (NCI)
Rutgers, The State University of New Jersey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to SparkPeople- Logged Food | 0-3 months after intervention | Average number of days per week logged food into SparkPeople |
| Acceptability of SparkPeople | 0-3 months after intervention | Usefulness of SparkPeople website on 1 (not useful at all) to 4 (very useful) scale |
| Adherence to Fitbit | 0-3 months after intervention | average days used Fitbit per week |
| Acceptability of Fitbit | 0-3 months after intervention | Usefulness of Fitbit, rated on 1 (not useful at all) to 4 (very useful) scale |
| Recruitment Rate | 12 months | Number of eligible participants who were enrolled and randomly assigned. Feasibility is defined as \>= 75% recruitment rate. |
| Retention Rate | 6 months | Number of participants completing study. Feasibility will be defined as \>= 80% retention rate. |
| Adherence to SparkPeople- Logged in | 0-3 months after intervention | average number of days logged per week in to SparkPeople website |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardiopulmonary Fitness | baseline and 3 months | change in fitness, measured by the 6-minute walk test |
| Social Support for Healthy Nutrition | baseline and 3 months | 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 |
| Change in Weight | baseline and 3 months | Change in weight from baseline |
| Change in Waist Circumference | baseline and 3 months | Change in waist circumference from baseline |
| Change in Caloric Intake | baseline and 3 months | Changes in caloric intake per day, measured by 24-hour recall |
| Change in Physical Activity | baseline and 3 months | change in average number of steps per day measured using Fitbit monitor |
| Change in Quality of Life | baseline and 3 months | measured using Quality of Life in Adult Cancer Survivors Scale (minimum 65, maximum 257); higher scores mean worse quality of life |
| Self-efficacy, Eating Healthy Foods | baseline and 3 months | change in self-efficacy, eating healthy foods, measured with Health Beliefs Survey, scale range 0 (certain I cannot) to 100 (certain I can) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group I (SparkPeople Program) Participants receive training on how to use the SparkPeople website, self-monitor their diet 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.
Behavioral Dietary Intervention: Use SparkPeople web-based program
Exercise Intervention: Use Fitbit monitor and SparkPeople web-based program
Activity Monitoring Device: Wear Fitbit activity monitoring device | 18 |
| Group II (Wait List) 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. | 17 |
| Total | 35 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Group I (SparkPeople Program) | Group II (Wait List) | Total |
|---|---|---|---|
| Age, Continuous | 61.20 years STANDARD_DEVIATION 10.26 | 62.25 years STANDARD_DEVIATION 6.66 | 61.67 years STANDARD_DEVIATION 8.74 |
| BMI | 35.51 kg/m^2 STANDARD_DEVIATION 6.98 | 38.40 kg/m^2 STANDARD_DEVIATION 6.94 | 36.73 kg/m^2 STANDARD_DEVIATION 6.84 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 0 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants | 17 Participants | 31 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 18 Participants | 17 Participants | 35 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 18 participants | 17 participants | 35 participants |
| Sex: Female, Male Female | 18 Participants | 17 Participants | 35 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 17 |
| other Total, other adverse events | 0 / 18 | 0 / 17 |
| serious Total, serious adverse events | 0 / 18 | 0 / 17 |
Outcome results
Primary
Acceptability of Fitbit
Usefulness of Fitbit, rated on 1 (not useful at all) to 4 (very useful) scale
Time frame: 4-6 months after intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group I (SparkPeople Program) | Acceptability of Fitbit | 4.00 score on a scale | Standard Deviation 0 |
| Group II (Wait List) | Acceptability of Fitbit | 4.00 score on a scale | Standard Deviation 0 |
Primary
Acceptability of Fitbit
Usefulness of Fitbit, rated on 1 (not useful at all) to 4 (very useful) scale
Time frame: 0-3 months after intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group I (SparkPeople Program) | Acceptability of Fitbit | 3.93 score on a scale | Standard Deviation 0.26 |
| Group II (Wait List) | Acceptability of Fitbit | 3.93 score on a scale | Standard Deviation 0.26 |
Primary
Acceptability of SparkPeople
Usefulness of SparkPeople website on 1 (not useful at all) to 4 (very useful) scale
Time frame: 0-3 months after intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group I (SparkPeople Program) | Acceptability of SparkPeople | 3.53 score on a scale | Standard Deviation 0.83 |
| Group II (Wait List) | Acceptability of SparkPeople | 3.60 score on a scale | Standard Deviation 0.52 |
Primary
Acceptability of SparkPeople
Usefulness of SparkPeople website on 1 (not useful at all) to 4 (very useful) scale
Time frame: 4-6 months after intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group I (SparkPeople Program) | Acceptability of SparkPeople | 3.53 score on a scale | Standard Deviation 0.8 |
| Group II (Wait List) | Acceptability of SparkPeople | 3.42 score on a scale | Standard Deviation 0.79 |
Primary
Adherence to Fitbit
average days used Fitbit per week
Time frame: 4-6 months after intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group I (SparkPeople Program) | Adherence to Fitbit | 5.57 days/week | Standard Deviation 1.83 |
| Group II (Wait List) | Adherence to Fitbit | 5.61 days/week | Standard Deviation 1.77 |
Primary
Adherence to Fitbit
average days used Fitbit per week
Time frame: 0-3 months after intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group I (SparkPeople Program) | Adherence to Fitbit | 6.24 days/week | Standard Deviation 0.84 |
| Group II (Wait List) | Adherence to Fitbit | 5.96 days/week | Standard Deviation 1.63 |
Primary
Adherence to SparkPeople- Logged Food
Average number of days per week logged food into SparkPeople
Time frame: 0-3 months after intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group I (SparkPeople Program) | Adherence to SparkPeople- Logged Food | 1.69 days/week | Standard Deviation 1.84 |
| Group II (Wait List) | Adherence to SparkPeople- Logged Food | 1.50 days/week | Standard Deviation 1.85 |
Primary
Adherence to SparkPeople- Logged Food
Average number of days per week logged food into SparkPeople
Time frame: 4-6 months after intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group I (SparkPeople Program) | Adherence to SparkPeople- Logged Food | 0.6 days/week | Standard Deviation 0.87 |
| Group II (Wait List) | Adherence to SparkPeople- Logged Food | 0.71 days/week | Standard Deviation 1.17 |
Primary
Adherence to SparkPeople- Logged in
average number of days logged per week in to SparkPeople website
Time frame: 0-3 months after intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group I (SparkPeople Program) | Adherence to SparkPeople- Logged in | 3.01 days/week | Standard Deviation 2.07 |
| Group II (Wait List) | Adherence to SparkPeople- Logged in | 2.30 days/week | Standard Deviation 2.27 |
Primary
Adherence to SparkPeople- Logged in
Average number of days per week logged in to SparkPeople website
Time frame: 4-6 months after intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group I (SparkPeople Program) | Adherence to SparkPeople- Logged in | 2.30 days/week | Standard Deviation 2.3 |
| Group II (Wait List) | Adherence to SparkPeople- Logged in | 1.14 days/week | Standard Deviation 1.64 |
Primary
Recruitment Rate
Number of eligible participants who were enrolled and randomly assigned. Feasibility is defined as \>= 75% recruitment rate.
Time frame: 12 months
Population: The overall number of participants is the number that were eligible for the study, hence it is greater than the number with results.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group I (SparkPeople Program) | Recruitment Rate | 18 Participants |
| Group II (Wait List) | Recruitment Rate | 17 Participants |
Primary
Retention Rate
Number of participants completing study. Feasibility will be defined as \>= 80% retention rate.
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group I (SparkPeople Program) | Retention Rate | 17 Participants |
| Group II (Wait List) | Retention Rate | 17 Participants |
Secondary
Cardiopulmonary Fitness
change in fitness, measured by the 6-minute walk test
Time frame: baseline and 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group I (SparkPeople Program) | Cardiopulmonary Fitness | 26.64 meters | Standard Deviation 35.88 |
| Group II (Wait List) | Cardiopulmonary Fitness | 31.97 meters | Standard Deviation 26.27 |
Secondary
Cardiopulmonary Fitness
change in fitness, measured by the 6-minute walk test
Time frame: baseline and 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group I (SparkPeople Program) | Cardiopulmonary Fitness | 0.81 meters | Standard Deviation 51.13 |
| Group II (Wait List) | Cardiopulmonary Fitness | 20.07 meters | Standard Deviation 52.81 |
Secondary
Change in Caloric Intake
Changes in caloric intake per day, measured by 24-hour recall
Time frame: baseline and 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group I (SparkPeople Program) | Change in Caloric Intake | -216.65 kcal/day | Standard Deviation 606.09 |
| Group II (Wait List) | Change in Caloric Intake | -173.06 kcal/day | Standard Deviation 805.4 |
Secondary
Change in Caloric Intake
Changes in caloric intake per day, measured by 24-hour recall
Time frame: baseline and 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group I (SparkPeople Program) | Change in Caloric Intake | -62.06 kcal/day | Standard Deviation 589.27 |
| Group II (Wait List) | Change in Caloric Intake | -386.38 kcal/day | Standard Deviation 514.95 |
Secondary
Change in Physical Activity
change in average number of steps per day measured using Fitbit monitor
Time frame: baseline and 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group I (SparkPeople Program) | Change in Physical Activity | 466.36 steps per day | Standard Deviation 2203.49 |
| Group II (Wait List) | Change in Physical Activity | -609.83 steps per day | Standard Deviation 2898.36 |
Secondary
Change in Physical Activity
change in average number of steps per day measured using Fitbit monitor
Time frame: baseline and 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group I (SparkPeople Program) | Change in Physical Activity | -107.07 steps per day | Standard Deviation 2184.94 |
| Group II (Wait List) | Change in Physical Activity | -205.47 steps per day | Standard Deviation 2147.79 |
Secondary
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
Time frame: baseline and 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group I (SparkPeople Program) | Change in Quality of Life | -9.44 units on a scale | Standard Deviation 16.97 |
| Group II (Wait List) | Change in Quality of Life | -4.65 units on a scale | Standard Deviation 24.21 |
Secondary
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
Time frame: baseline and 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group I (SparkPeople Program) | Change in Quality of Life | -5.44 units on a scale | Standard Deviation 18.11 |
| Group II (Wait List) | Change in Quality of Life | -4.35 units on a scale | Standard Deviation 16.69 |
Secondary
Change in Waist Circumference
Change in waist circumference from baseline
Time frame: baseline and 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group I (SparkPeople Program) | Change in Waist Circumference | -3.56 cm | Standard Deviation 4.7 |
| Group II (Wait List) | Change in Waist Circumference | -0.84 cm | Standard Deviation 5.21 |
Secondary
Change in Waist Circumference
Change in waist circumference from baseline
Time frame: baseline and 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group I (SparkPeople Program) | Change in Waist Circumference | -1.98 cm | Standard Deviation 5.39 |
| Group II (Wait List) | Change in Waist Circumference | -0.05 cm | Standard Deviation 5.56 |
Secondary
Change in Weight
Change in weight from baseline
Time frame: baseline and 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group I (SparkPeople Program) | Change in Weight | -2.10 kg | Standard Deviation 2.64 |
| Group II (Wait List) | Change in Weight | -2.26 kg | Standard Deviation 2.16 |
Secondary
Change in Weight
Change in weight from baseline
Time frame: baseline and 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group I (SparkPeople Program) | Change in Weight | -1.71 kg | Standard Deviation 1.88 |
| Group II (Wait List) | Change in Weight | -2.53 kg | Standard Deviation 4 |
Secondary
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)
Time frame: baseline and 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group I (SparkPeople Program) | Self-efficacy, Eating Healthy Foods | 2.14 units on a scale | Standard Deviation 8.17 |
| Group II (Wait List) | Self-efficacy, Eating Healthy Foods | -0.41 units on a scale | Standard Deviation 13.47 |
Secondary
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)
Time frame: baseline and 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group I (SparkPeople Program) | Self-efficacy, Eating Healthy Foods | 5.59 units on a scale | Standard Deviation 12.63 |
| Group II (Wait List) | Self-efficacy, Eating Healthy Foods | -6.59 units on a scale | Standard Deviation 15.36 |
Secondary
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
Time frame: baseline and 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group I (SparkPeople Program) | Social Support for Healthy Nutrition | 0.40 units on a scale | Standard Deviation 0.58 |
| Group II (Wait List) | Social Support for Healthy Nutrition | 0.11 units on a scale | Standard Deviation 0.56 |
Secondary
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
Time frame: baseline and 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group I (SparkPeople Program) | Social Support for Healthy Nutrition | 0.39 units on a scale | Standard Deviation 0.85 |
| Group II (Wait List) | Social Support for Healthy Nutrition | 0.11 units on a scale | Standard Deviation 0.71 |