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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Educational Intervention — OTHER
    Receive standard of care verbal and written education materials
  • Questionnaire Administration — OTHER
    Ancillary studies
  • Survey Administration — OTHER
    Complete optional survey
  • Video — OTHER
    Watch 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

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030
Caroline Chung
713-563-2300
Caroline Chung (PRINCIPAL_INVESTIGATOR)

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