Customized Neuro-Imaging Referenced Symptom Video for the Reduction of Patient and Caregiver Anxiety Around Radiation Treatment for Brain Tumors
Part of paid clinical trials in Houston, Texas.
- Sponsor
- M.D. Anderson Cancer Center
- Study ID
- NCT04479696
- Status
- Recruiting
Conditions
- Glioblastoma
- WHO Grade II Glioma
- WHO Grade III Glioma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- Educational Intervention — OTHERReceive standard of care verbal and written education materials
- Questionnaire Administration — OTHERAncillary studies
- Survey Administration — OTHERComplete optional survey
- Video — OTHERWatch NIRS video
Study Details
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 referenced symptom video that describes symptoms and side effects specific to the patients' tumor may result in an early and sustained reduction in anxiety and distress during and after radiation treatment, thereby improving quality of life.
Key Dates
- Start date
- Jun 5, 2019
- Status verified
- Jan 2025
- Primary completion
- Jun 1, 2026
- Completion
- Jun 1, 2026
Study Design
- Enrollment
- 117 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Experimental: Arm I (NIRS)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.
- Active Comparator: Arm II (standard of care)Patients receive standard of care verbal and written education materials.
Primary Outcome Measure
Changes in patient S-Anxiety subscale score of the State-Trait Anxiety Inventory (STAI) [ Time Frame: From baseline to 2 weeks, 6 weeks and 1 month post-radiation therapy (RT) ]
Central Contacts
- Caroline Chung713-745-5422
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | Caroline Chung 713-563-2300 Caroline Chung (PRINCIPAL_INVESTIGATOR) |
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