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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

Be older than 18 years old

Must not have

PATIENT ELIGIBILITY CRITERIA: Poor performance status (Karnofsky performance status [KPS] < 60) that prevent the ability to complete the questionnaires

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to 2 weeks, 6 weeks, and 1 month post-rt

Awards & highlights

No Placebo-Only Group

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.

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.

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

Select...

I have a newly diagnosed brain tumor and am set for radiotherapy after surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am unable to complete daily tasks without assistance.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to 2 weeks, 6 weeks, and 1 month post-rt

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Anxiety

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 2Eligibility criteria met