Recruiting

Observational Study

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT04479696

Conditions

Glioblastoma

WHO Grade II Glioma

WHO Grade III Glioma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Educational Intervention

Questionnaire Administration

Survey Administration

Video

Study Details

Brief 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.

Conditions

Glioblastoma

WHO Grade II Glioma

WHO Grade III Glioma

Study ID

NCT04479696

Start date

Jun 5, 2019

Status verified date

Jul, 2026

Completion date

Feb 2, 2027

Anticipated

Primary completion date

Feb 2, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

117 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

Interventions

Educational Intervention

Receive standard of care verbal and written education materials

Questionnaire Administration

Ancillary studies

Survey Administration

Complete optional survey

Video

Watch NIRS video

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 and Locations

Central contacts

Caroline Chung

713-745-5422cchung3@mdanderson.org

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Caroline Chung

713-563-2300

Principal Investigator:

Caroline Chung

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Jul 20, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-07-20.