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Survivorship Study of Cancer Patients Who Received Cranial Radiation Therapy

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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04567251
Acronym
SPiRiT
Enrollment
5
Registered
2020-09-28
Start date
2021-12-28
Completion date
2024-05-29
Last updated
2025-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Metastases, Adult, Lung Cancer, Primary Brain Tumor

Keywords

Pro00102684, Katherine Peters, Lung Cancer, Brain metastases, Brain tumor, Radiation, Solid tumor, Cognition, Pediatric Cancer, Cancer Survivor, Survivorship, Noona, Healthcare Mobile Application

Brief summary

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

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.

Interventions

OTHERNoona® application

A digital symptom tracking application focused on Health-Related Quality of Life (HRQOL) and cognition in cancer survivors who received brain irradiation

Sponsors

Varian Medical Systems
CollaboratorINDUSTRY
Duke University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. 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 2. 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 3. Age ≥ 18 years at the time of entry into the study 4. Karnofsky performance score (KPS) ≥ 70 or Eastern Cooperative Oncology Group (ECOG) grade ≤ 2 5. No imaging evidence of disease progression within 4 months of enrollment 6. Life expectancy \> 6 months per treating neuro-oncology providers 7. Access to a smartphone, tablet, or computer with capability to utilize the mobile symptom-tracking application 8. Subject must be fluent in English

Exclusion criteria

1\. Active psychiatric illness

Design outcomes

Primary

MeasureTime frameDescription
Feasibility of using a digital symptom tracking application focused on HRQoL and cognition in cancer survivors who received brain irradiationBaseline, 15 weeksThe percentage of patients returning for their Week 15 clinic appointment who initiate PROMIS and ESAS questionnaires via the mobile application at Week 14

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026