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

Duke University

Status and phase: Enrolling; Phase 3

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

Treatments: Drug: Namzaric®; Drug: Placebo

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04567251

Pro00102684

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

50 participants in 1 patient group

Noona® mobile healthcare application

Description:

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.