Cancer, Cardiovascular Diseases
Conditions
Keywords
Physical activity, Wearable, Communication
Brief summary
The Survivor mobile health (mHealth) study is testing the use of wearable devices (Fitbits) and a smartphone application in cancer survivors. The goal of the program is to increase survivor's physical activity levels. The Fitbit will be synced to the app and participants will receive messages and notifications about their activity levels. Participants will also complete surveys through the app asking how useful it is and ways to improve it. The study team will conduct qualitative interviews at the completion of the 3 months to see how participants liked the program, and ways it can be improved and make it more specific to cancer survivors. The study team will also conduct interviews with providers and clinic staff to assess their perceptions of patient digital health programs and preferences for receiving patient-generated health data.
Interventions
BEHAVIORALWearable device deployment
Participants will receive a Fitbit to be synced with a smartphone app (MyDataHelps). Participants will receive push notifications to complete surveys via the MyDataHelps app. The Fitbit will sync with the app for data collection.
Sponsors
National Cancer Institute (NCI)
National Heart, Lung, and Blood Institute (NHLBI)
University of Massachusetts, Worcester
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
Inclusion criteria
Aims 1 and 2 Inclusion Criteria: 1. Past cancer diagnosis 2. At least 18 years of age 3. Capacity to provide informed consent 4. Medically cleared to perform physical activity (as noted by Physical Activity Readiness Questionnaire form or physician's clearance if needed) 5. Owns a smartphone Aims 1 and 2
Exclusion criteria
1. Is a prisoner 2. Non-English speaking 3. Is unable to provide consent 4. Under 18 years of age 5. No prior cancer diagnosis 6. Does not own a smartphone Aim 3 Inclusion Criteria: 1. Are a current UMass Memorial Cancer Clinic patient navigator, oncologist, radiologist, or cardiologist 2. Consent to participate Aim 3
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Enrollment | Baseline | Feasibility will be determined by a participant meeting all three criteria: 1) Enrollment in trial, 2) completion of baseline measures, and 3) Fitbit sync to app. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 3-month Daily Step Count | At study completion, within 3-months of enrollment | The mean number of steps taken per day during week 12 of the intervention. |
| 1-Month Usability Overall APP Rating | 1-month post-enrollment | Mobile Application Rating Scale (MARS). The Rating scale assesses app quality on four dimensions. All items are rated on a 5-point scale from 1.Inadequate to 5.Excellent. The mean was taken from the overall app usability question and reported. A higher score indicates greater user acceptability of the app. The lowest possible score is a 1, and the highest possible score is a 5. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Wearable Device Deployment Participants will be enrolled in the experimental trial to receive Fitbits and a smartphone app.
Wearable device deployment: Participants will receive a Fitbit to be synced with a smartphone app (MyDataHelps). Participants will receive push notifications to complete surveys via the MyDataHelps app. The Fitbit will sync with the app for data collection. | 31 |
| Total | 31 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Wearable Device Deployment |
|---|---|
| Age, Continuous | 64.7 years STANDARD_DEVIATION 11.1 |
| Annual Household income <$25,000 | 2 Participants |
| Annual Household income $25,000 to $50,000 | 5 Participants |
| Annual Household income $50,001 to $75,000 | 4 Participants |
| Annual Household income >$75,000 | 18 Participants |
| Annual Household income Unknown | 2 Participants |
| Cancer type Blood | 2 Participants |
| Cancer type Breast | 4 Participants |
| Cancer type Colon | 1 Participants |
| Cancer type Gynecologic | 2 Participants |
| Cancer type Kidney | 1 Participants |
| Cancer type Prostate | 9 Participants |
| Cancer type Skin | 2 Participants |
| Cancer type Throat | 2 Participants |
| Cancer type Thyroid | 2 Participants |
| Cancer type Unknown | 6 Participants |
| Education level Advanced college degree | 11 Participants |
| Education level Bachelor's degree | 6 Participants |
| Education level High school or less | 7 Participants |
| Education level Some college | 7 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 24 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 20 Participants |
| Region of Enrollment United States | 31 participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 31 |
| other Total, other adverse events | 0 / 31 |
| serious Total, serious adverse events | 0 / 31 |
Outcome results
Primary
Feasibility of Enrollment
Feasibility will be determined by a participant meeting all three criteria: 1) Enrollment in trial, 2) completion of baseline measures, and 3) Fitbit sync to app.
Time frame: Baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Wearable Device Deployment | Feasibility of Enrollment | 30 Participants |
Secondary
1-Month Usability Overall APP Rating
Mobile Application Rating Scale (MARS). The Rating scale assesses app quality on four dimensions. All items are rated on a 5-point scale from 1.Inadequate to 5.Excellent. The mean was taken from the overall app usability question and reported. A higher score indicates greater user acceptability of the app. The lowest possible score is a 1, and the highest possible score is a 5.
Time frame: 1-month post-enrollment
Population: Completed 1-month usability survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Wearable Device Deployment | 1-Month Usability Overall APP Rating | 3.79 units on a scale | Standard Deviation 0.82 |
Secondary
3-month Daily Step Count
The mean number of steps taken per day during week 12 of the intervention.
Time frame: At study completion, within 3-months of enrollment
Population: Number of participants with validated wear-time.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Wearable Device Deployment | 3-month Daily Step Count | 6687 Steps/day | Standard Deviation 3183 |