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| ID | Type | Description | Link |
|---|---|---|---|
| 5P50CA244693-02 | U.S. NIH Grant/Contract | View source | |
| 1K12HL138049-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wearable device deployment | Experimental | Participants will be enrolled in the experimental trial to receive Fitbits and a smartphone app. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wearable device deployment | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 3-month Daily Step Count | The mean number of steps taken per day during week 12 of the intervention. | At study completion, within 3-months of enrollment |
| 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. |
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Aims 1 and 2 Inclusion Criteria:
Aims 1 and 2 Exclusion Criteria:
Aim 3 Inclusion Criteria:
Aim 3 Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jamie M Faro, PhD | University of Massachusetts, Worcester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Massachusetts Chan Medical School | Worcester | Massachusetts | 01605 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | Baseline |
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12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Reem Najjar | UMass Chan Medical School | 7742750890 | Reem.najjar@umassmed.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 21, 2023 | Aug 23, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D002318 | Cardiovascular Diseases |
| D009043 | Motor Activity |
| D003142 | Communication |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| 1-month post-enrollment |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Education level | Count of Participants | Participants |
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| Cancer type | Count of Participants | Participants |
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| Annual Household income | Count of Participants | Participants |
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| Participants |
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| Secondary | 3-month Daily Step Count | The mean number of steps taken per day during week 12 of the intervention. | Number of participants with validated wear-time. | Posted | Mean | Standard Deviation | Steps/day | At study completion, within 3-months of enrollment |
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| 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. | Completed 1-month usability survey. | Posted | Mean | Standard Deviation | units on a scale | 1-month post-enrollment |
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| 31 |
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