Survivorship Study of Cancer Patients Who Received Cranial Radiation Therapy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Survivorship Study of Cancer Patients Who Received Cranial Radiation Therapy: Focus on Health-Related Quality of Life and Cognition

Conditions
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Brain Metastases, Adult, Primary Brain Tumor, Lung Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Initial radiation must have been completed more than 6 months prior to enrollment. Acceptable radiation therapies include fractionated partial brain irradiation, whole brain irradiation, or stereotactic radiosurgery (for any modality at least a total cumulative dose of 20 Gy) of at least 20 Gy Age ≥ 18 years at the time of entry into the study Karnofsky performance score (KPS) ≥ 70 or Eastern Cooperative Oncology Group (ECOG) grade ≤ 2 No imaging evidence of disease progression within 4 months of enrollment Life expectancy > 6 months per treating neuro-oncology providers Access to a smartphone, tablet, or computer with capability to utilize the mobile symptom-tracking application Subject must be fluent in English Exclusion Criteria: 1. Active psychiatric illness

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Noona® mobile healthcare application<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pro00102684, Katherine Peters, Lung Cancer, Brain metastases, Brain tumor, Radiation, Solid tumor, Cognition, Pediatric Cancer, Cancer Survivor, Survivorship, Noona, Healthcare Mobile Application