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

Official title

Novel Intervention to Reduce Patient and Caregiver Anxiety Around Radiation Treatment for Brain Tumors With a Customized Neuro-Imaging Referenced Symptom Video

Overview

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.

Detailed 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.

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

Primary outcome measures

• 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)]

Secondary outcome measures (4)

• Changes in caregiver S-Anxiety subscale score of the STAI and Distress Thermometer score [Time frame: From baseline to 2 and 6 weeks]
• Change in patient and caregiver S-Anxiety subscale score of the STAI and Distress Thermometer scores [Time frame: From baseline to 1 month post-RT]
• Changes in patient Distress Thermometer score and FACT-Br score [Time frame: From baseline to 2 weeks, 6 weeks, and 1 month post-RT]
• Patient survey [Time frame: Up to 1 month post-RT]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 1 center

• M D Anderson Cancer Center — Houston

Identifiers

NCT: NCT04479696 · 2018-0097 · NCI-2020-03698 · 2018-0097

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗