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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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This study assesses the association between digital functional measures of physical and patient-reported standard onocological assessments, like Karnofsky Performance Score (KPS).
This study assess the association between digital functional measures from physical monitoring devices (devices like a watch tracking steps, a heart rate monitor) and patient-reported standard oncological assessments. The study will also test the feasibility of obtaining the measures in clinic and at home from the monitoring devices in participants with cancer. Participants will be asked to spend 1 hour in clinic performing simple tasks such as walking and standing with 7 digital devices recording movement data. The participants will also be asked to fill out survey data regarding their health. At-home data will be collected for 14 days. During this time participants will wear a watch to collect movement and step data, and a lumbar belt to collect movement data.
Primary Objective:
1. Assess the association of 5 main digital physical functional measures (mean steps per day, mean sedentary activity time, light activity time, moderate activity time, and vigorous activity time (in minutes) per day) recorded at home with patient-reported standard oncological assessment (e.g. KPS)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Digital Physical Measures and Survey Assessments | Experimental | Digital physical measure data will be collected in clinic and at home and survey assessments will be collected |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital Physical Measures and Survey Assessments | Other | Data from at home and in clinic visits will assess physical function and survey data will be collected |
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| Measure | Description | Time Frame |
|---|---|---|
| Amount of mean steps per day recorded at home | At-home record of mean steps per day | 18 months |
| Amount of mean sedentary activity time recorded at home | At-home record of minutes per day of mean sedentary activity time | 18 months |
| Amount of Light activity time recorded at home | At-home record of minutes per day of light activity time per day | 18 months |
| Amount of moderate activity time recorded at home | At-home record of minutes per day of moderate activity time | 18 months |
| Amount of vigorous activity time recorded at home | At-home record of minutes per day of vigorous activity time | 18 months |
| Self-Reported Karnofsky Performance Score (KPS) | The validated 1 question Self-reported Karnofsky Performance Score (KPS) score 0 to 100 will be measured. Scores closer to 100 indicate high performance of the patient | 18 months |
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Inclusion Criteria:
Signed and dated informed consent and HIPPA.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNC Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | 27599 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40399391 | Derived | Karahanoglu FI, Jensen CE, Cai X, Santamaria M, Psaltos D, Messere A, Demanuele C, Stone J, Tarachandani A, Adamowicz L, Muss H, Wood WA. Improved functional assessment in cancer patients using home-based digital technologies. Sci Rep. 2025 May 21;15(1):17638. doi: 10.1038/s41598-025-02401-4. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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