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Educational Video for Brain Cancer

N/A
Recruiting
Led By Caroline Chung
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
CAREGIVER ELIGIBILITY CRITERIA: Adult caregiver (>= 18 years) who is accompanying an eligible patient consented to the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to 2 weeks, 6 weeks, and 1 month post-rt
Awards & highlights

Study Summary

This trial studies a customized video intervention to see if it can reduce anxiety for brain cancer patients undergoing radiation treatment and their caregivers.

Who is the study for?
This trial is for adult patients with newly diagnosed glioma (grades 2-4) who are about to start a 6-week radiotherapy post-surgery and can fill out questionnaires in English. It also includes their adult caregivers who can do the same. Those with significant cognitive or psychiatric issues, or poor performance status (KPS < 60), cannot participate.Check my eligibility
What is being tested?
The study tests if a personalized video explaining symptoms and side effects related to the patient's brain tumor can reduce anxiety for both patients and caregivers during radiation treatment, potentially improving quality of life.See study design
What are the potential side effects?
Since this intervention involves educational materials rather than medical treatments, traditional physical side effects are not expected. However, there may be emotional reactions to the content of the videos.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a newly diagnosed brain tumor and am set for radiotherapy after surgery.
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I am an adult caregiver (18+) for a patient in this study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to 2 weeks, 6 weeks, and 1 month post-rt
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to 2 weeks, 6 weeks, and 1 month post-rt for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Anxiety
Secondary outcome measures
Change in patient and caregiver S-Anxiety subscale score of the STAI and Distress Thermometer scores
Anxiety
Changes in patient Distress Thermometer score and FACT-Br score
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (NIRS)Experimental Treatment4 Interventions
Patients receive standard of care verbal and written education materials. Patients also receive a customized video which includes a description of each of their tumor, functional areas of the brain affected, and possible symptoms from the tumor and radiation treatment based on the neuro-imaging features. Patients and their caregivers watch the video together or separately over 1.5-3 minutes before the end of the first week of radiation treatment. Within 2 weeks after watching the NIRS video, patients complete an optional survey over 5-10 minutes.
Group II: Arm II (standard of care)Active Control2 Interventions
Patients receive standard of care verbal and written education materials.

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,966 Previous Clinical Trials
1,804,679 Total Patients Enrolled
2 Trials studying Gliomas
20 Patients Enrolled for Gliomas
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,932,221 Total Patients Enrolled
5 Trials studying Gliomas
292 Patients Enrolled for Gliomas
Caroline ChungPrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
172 Total Patients Enrolled

Media Library

Video 2023 Treatment Timeline for Medical Study. Trial Name: NCT04479696 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people have been accepted as participants in this experiment?

"This is correct. As per information from clinicaltrials.gov, this medical experiment was first posted on June 5th 2019 and is still recruiting participants. 102 volunteers are expected to be enrolled at 1 particular location for the study's duration."

Answered by AI

Is this opportunity for participation still accessible?

"Affirmative. Clinicaltrials.gov attests that this research study, initially posted on June 5th 2019, is presently recruiting participants. Approximately 102 volunteers must be enlisted from 1 medical centre."

Answered by AI
~37 spots leftby Feb 2027