Survivorship Study of Cancer Patients Who Received Cranial Radiation Therapy

NCT04567251 | Terminated

• 1 other identifier: Pro00102684
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Metastases, Adult; Primary Brain Tumor; Lung Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

Other: Noona® application

Interventions

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

Noona® mobile healthcare application

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• \. Active psychiatric illness

Sponsors & Collaborators

• Duke University: lead
• Varian Medical Systems: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Links

• Duke Health Clinical Trials
• The Preston Robert Tisch Brain Tumor Center

MeSH Terms

Conditions

Brain Neoplasms; Lung Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Katherine Peters, MD, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2020
• First Posted: September 28, 2020
• Study Start: December 28, 2021
• Primary Completion: May 29, 2024
• Study Completion: May 29, 2024
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)