Customized Neuro-Imaging Referenced Symptom Video for the Reduction of Patient and Caregiver Anxiety Around Radiation Treatment for Brain Tumors
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- STATUS
- Recruiting
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- participants needed
- 102
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- sponsor
- M.D. Anderson Cancer Center
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 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.
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 patient anxiety during radiation compared to standard of care information.
SECONDARY OBJECTIVES:
I. To determine if provision of a NIRS video intervention for patients starting radiotherapy for newly diagnosed primary brain tumors reduces caregiver anxiety during radiation compared to standard of care information.
II. To determine if any changes in patient or caregiver anxiety early during radiation are sustained after the completion of radiation.
III. To investigate whether changes in anxiety are associated with changes in quality of life and distress in patients.
IV. To investigate whether patients perceive the NIRS intervention to have been helpful in understanding possible tumor and treatment symptoms.
OUTLINE: Patients and their caregivers are randomized to 1 of 2 arms.
ARM I (NIRS VIDEO): Patients receive standard of care verbal and written education materials. Patients also receive a customized NIRS video which includes a description of each 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.
ARM II (STANDARD OF CARE EDUCATION): Patients receive standard of care verbal and written education materials.
After completion of radiation treatment, patients are followed up at 1 month.
Details
| Condition | Glioblastoma Multiforme, Glioblastoma Multiforme, WHO Grade II Glioma, WHO Grade III Glioma |
|---|---|
| Age | 18-100 years |
| Treatment | Questionnaire Administration, Survey Administration, Educational intervention, Video |
| Clinical Study Identifier | NCT04479696 |
| Sponsor | M.D. Anderson Cancer Center |
| Last Modified on | 19 February 2024 |
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Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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