Survivorship Study of Cancer Patients Who Received Cranial Radiation Therapy

Lung Cancer Clinical Trial

— SPiRiT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04567251
• Other study ID #: Pro00102684
• Status: Recruiting
• Start date: December 28, 2021
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: Duke University
• Contact: Katherine Peters, MD, PhD
• Phone: 919-684-5301
• Email: dukebrain1[@]duke.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Metastases, Adult
• Brain Neoplasms
• Lung Cancer
• Neoplasm Metastasis
• Primary Brain Tumor

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Varian Medical Systems

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

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