Ignite Creation Date:
2024-05-06 @ 3:14 PM
Last Modification Date:
2024-10-26 @ 1:45 PM
Study NCT ID:
NCT04567251
Status:
RECRUITING
Last Update Posted:
2024-05-17
First Post:
2020-09-23
Brief Title:
Survivorship Study of Cancer Patients Who Received Cranial Radiation Therapy
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Survivorship Study of Cancer Patients Who Received Cranial Radiation Therapy Focus on Health-Related Quality of Life and Cognition
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPiRiT
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None