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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04479696
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

M.D. Anderson Cancer Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Caroline Chung
Principal Investigator Affiliation M.D. Anderson Cancer Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, NIH
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Glioblastoma, WHO Grade II Glioma, WHO Grade III Glioma
Study Website: View Trial Website
Additional Details

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.

Arms & Interventions

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

Other: - Educational Intervention

Receive standard of care verbal and written education materials

Other: - Questionnaire Administration

Ancillary studies

Other: - Survey Administration

Complete optional survey

Other: - Video

Watch NIRS video

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

M D Anderson Cancer Center, Houston, Texas

Status

Recruiting

Address

M D Anderson Cancer Center

Houston, Texas, 77030

Site Contact

Caroline Chung

[email protected]

713-563-2300

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