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

NCT04479696 | Recruiting

• 2 other identifiers: 2018-0097NCI-2020-03698
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Changes in patient S-Anxiety subscale score of the State-Trait Anxiety Inventory (STAI)

  Using linear mixed models (LMMs) to evaluate the change in STAI between and within groups. The correlation structure over time will be selected using the Bayesian information criterion. Will calculate correlations between reduction in anxiety and improvement in quality of life (Functional Assessment of Cancer Therapy Scale-Brain \[FACT- Br\]) and distress (Distress Thermometer). Analysis will focus on the between-group comparison of the changes of the patient S-Anxiety subscale score of the STAI from baseline to 2 weeks and from baseline to 6 weeks in to RT. All tests conducted will use a two-sided 0.05 significance level, without adjusting for multiple testing.

  From baseline to 2 weeks, 6 weeks and 1 month post-radiation therapy (RT)

Secondary Outcomes (4)

• Changes in caregiver S-Anxiety subscale score of the STAI and Distress Thermometer score

  From baseline to 2 and 6 weeks

• Change in patient and caregiver S-Anxiety subscale score of the STAI and Distress Thermometer scores

  From baseline to 1 month post-RT

• Changes in patient Distress Thermometer score and FACT-Br score

  From baseline to 2 weeks, 6 weeks, and 1 month post-RT

• Patient survey

  Up to 1 month post-RT

Study Arms (2)

Arm I (NIRS)

EXPERIMENTAL

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.

Other: Educational Intervention; Other: Questionnaire Administration; Other: Survey Administration; Other: Video

Arm II (standard of care)

ACTIVE COMPARATOR

Patients receive standard of care verbal and written education materials.

Other: Educational Intervention; Other: Questionnaire Administration

Interventions

Questionnaire Administration OTHER

Ancillary studies

Arm I (NIRS); Arm II (standard of care)

Survey Administration OTHER

Complete optional survey

Arm I (NIRS)

Video OTHER

Watch NIRS video

Arm I (NIRS)

Educational Intervention OTHER

Receive standard of care verbal and written education materials

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Arm I (NIRS); Arm II (standard of care)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Conditions

Glioblastoma

Interventions

Early Intervention, Educational; Educational Status; Methods; Videotape Recording

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Investigative Techniques; Tape Recording; Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture; Television

Study Officials

• Caroline Chung

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Caroline Chung

CONTACT

713-745-5422; cchung3@mdanderson.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2020
• First Posted: July 21, 2020
• Study Start: June 5, 2019
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 20, 2026

Record last verified: 2025-01

Locations

US (1)