Survivorship Study of Cancer Patients Who Received Cranial Radiation Therapy (SPiRiT)

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

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.

Study Overview

• Status: Terminated
• Conditions: Lung Cancer; Primary Brain Tumor; Brain Metastases, Adult
• Intervention / Treatment: Other: Noona® application

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.

• Study Type: Observational
• Enrollment (Actual): 5
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Varian Medical Systems
• Investigators: Principal Investigator: Katherine Peters, MD, PhD, Duke University

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): December 28, 2021
• Primary Completion (Actual): May 29, 2024
• Study Completion (Actual): May 29, 2024

Study Registration Dates

• First Submitted: September 23, 2020
• First Submitted That Met QC Criteria: September 23, 2020
• First Posted (Actual): September 28, 2020

Study Record Updates

• Last Update Posted (Actual): May 14, 2025
• Last Update Submitted That Met QC Criteria: May 9, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Lung Cancer; Brain tumor; Cognition; Pediatric Cancer; Solid tumor; Survivorship; Radiation; Cancer Survivor; Brain metastases; Katherine Peters; Pro00102684; Noona; Healthcare Mobile Application
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pathologic Processes; Neoplasms by Site; Neoplasms; Neoplastic Processes; Nervous System Neoplasms; Central Nervous System Neoplasms; Neoplasm Metastasis; Brain Neoplasms
• Other Study ID Numbers: Pro00102684

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No