Customized video to reduce anxiety for brain tumor patients and caregivers during radiation treatment
Novel Intervention to Reduce Patient and Caregiver Anxiety Around Radiation Treatment for Brain Tumors With a Customized Neuro-Imaging Referenced Symptom Video
This study tests if a personalized video can help reduce anxiety for brain tumor patients and their caregivers during radiation treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 117 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT04479696 on ClinicalTrials.gov |
What this trial studies
This trial investigates whether a customized neuro-imaging referenced symptom video can alleviate anxiety in patients with newly diagnosed brain tumors and their caregivers undergoing radiation treatment. Participants are randomized into two groups: one receiving standard care information and the other receiving the customized video intervention. The study aims to assess the impact of the video on anxiety levels during and after radiation, as well as its effects on quality of life and distress. The intervention is designed to provide tailored information about the patient's specific tumor and treatment-related symptoms.
Who should consider this trial
Good fit: Ideal candidates include adult patients with newly diagnosed gliomas (WHO grade 2-4) who are scheduled for a 6-week course of radiotherapy after surgery.
Not a fit: Patients with significant cognitive or psychiatric symptoms that hinder their ability to complete questionnaires may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce anxiety and improve the quality of life for brain tumor patients and their caregivers during a challenging treatment process.
How similar studies have performed: Other studies have shown promising results using educational interventions to reduce anxiety in cancer patients, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Caroline Chung — M.D. Anderson Cancer Center
- Study coordinator: Caroline Chung
- Email: cchung3@mdanderson.org
- Phone: 713-745-5422
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.