Status:
RECRUITING
Customized Neuro-Imaging Referenced Symptom Video for the Reduction of Patient and Caregiver Anxiety Around Radiation Treatment for Brain Tumors
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Glioblastoma
WHO Grade II Glioma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This trial studies whether a customized video intervention can help to reduce anxiety in brain cancer patients undergoing radiation treatment and their caregivers. A customized neuro-imaging reference...
Detailed Description
PRIMARY OBJECTIVE: I. To determine if provision of a neuro-imaging referenced symptom (NIRS) video intervention for patients starting radiotherapy for newly diagnosed primary brain tumors reduces pat...
Eligibility Criteria
Inclusion
- PATIENT ELIGIBILITY CRITERIA: Adult patients with newly diagnosed glioma (World Health Organization \[WHO\] grade 2-4) who are planned for a 6-week course of radiotherapy after surgery
- PATIENT ELIGIBILITY CRITERIA: Able to complete questionnaires in English
- PATIENT ELIGIBILITY CRITERIA: Has a post-operative diagnostic magnetic resonance imaging (MRI) of the brain with and without contrast acquired within 4 weeks of the start of radiotherapy
- CAREGIVER ELIGIBILITY CRITERIA: Adult caregiver (\>= 18 years) who is accompanying an eligible patient consented to the study
- CAREGIVER ELIGIBILITY CRITERIA: The patient who the caregiver is accompanying is consented for participation on the study
- CAREGIVER ELIGIBILITY CRITERIA: Able and willing to complete questionnaires in English
Exclusion
- PATIENT ELIGIBILITY CRITERIA: Significant cognitive or psychiatric symptoms that prevent the ability to complete the questionnaires as determined by the assessing staff in the pre-intervention evaluation
- PATIENT ELIGIBILITY CRITERIA: Poor performance status (Karnofsky performance status \[KPS\] \< 60) that prevent the ability to complete the questionnaires
- CAREGIVER ELIGIBILITY CRITERIA: Significant cognitive or psychiatric symptoms that prevent the ability to complete the questionnaires as determined by the assessing staff in the pre-intervention evaluation
Key Trial Info
Start Date :
June 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 2 2027
Estimated Enrollment :
117 Patients enrolled
Trial Details
Trial ID
NCT04479696
Start Date
June 5 2019
End Date
February 2 2027
Last Update
June 10 2025
Active Locations (1)
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1
M D Anderson Cancer Center
Houston, Texas, United States, 77030