Customized Neuro-Imaging Referenced Symptom Video for the Reduction of Patient and Caregiver Anxiety Around Radiation Treatment for Brain Tumors

  • STATUS
    Recruiting
  • End date
    Jun 30, 2022
  • participants needed
    102
  • sponsor
    M.D. Anderson Cancer Center
Updated on 25 January 2021
cancer
MRI
brain tumor
malignant brain tumor

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, WHO Grade III Glioma, Anaplastic Glioma, WHO Grade II Glioma, glioblastoma
Treatment questionnaire administration, educational intervention, survey administration, Video
Clinical Study IdentifierNCT04479696
SponsorM.D. Anderson Cancer Center
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

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
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