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PRMC closed for low accrual
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| Name | Class |
|---|---|
| Varian Medical Systems | INDUSTRY |
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This study represents a survivorship protocol that focuses on cognition and health-related quality of life (HRQoL) in cancer patients that have received prior brain irradiation. The primary purpose of this study is to assess the feasibility of using a digital symptom tracking application focused on HRQoL and cognition in cancer survivors who received brain irradiation.
Patients who may participate in the study are cancer survivors who received cranial irradiation for conditions including, but not limited to: primary brain tumors, brain metastases, patients with lung cancer receiving prophylactic brain irradiation, and long-term survivors of pediatric cancers. Patients will use the Noona® Healthcare Mobile PRO Application to identify real time select HRQoL and cognitive symptoms. Patients will be instructed to log symptoms as often as relevant using their own personal devices, as well as be prompted to fill out the Patient-Reported Outcomes Measurement Information System Global Health Screen (PROMIS Global Health-10 and Edmonton Symptom Assessment Scale) during treatment (weeks 9 and 14). Patient engagement with the application will be tracked to determine feasibility.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Noona® mobile healthcare application | All patients will be instructed to report pre-defined, non-life-threatening cognitive symptoms as often as relevant through the Noona® application for 17 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Noona® application | Other | A digital symptom tracking application focused on Health-Related Quality of Life (HRQOL) and cognition in cancer survivors who received brain irradiation |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of using a digital symptom tracking application focused on HRQoL and cognition in cancer survivors who received brain irradiation | The percentage of patients returning for their Week 15 clinic appointment who initiate PROMIS and ESAS questionnaires via the mobile application at Week 14 | Baseline, 15 weeks |
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Inclusion Criteria:
Exclusion Criteria:
1. Active psychiatric illness
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Cancer survivors who received cranial irradiation including, but not limited to, primary brain tumor, brain metastases, lung cancer receiving prophylactic brain irradiation, long-term survivors of pediatric cancers
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| Name | Affiliation | Role |
|---|---|---|
| Katherine Peters, MD, PhD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
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| Label | URL |
|---|---|
| Duke Health Clinical Trials | View source |
| The Preston Robert Tisch Brain Tumor Center | View source |
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| D008175 | Lung Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D001927 | Brain Diseases |
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| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |