RECRUITING

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

Conditions

Glioblastoma WHO Grade II Glioma WHO Grade III Glioma

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2019-06-05

Study Completion:2027-02-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04479696

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Caroline Chung

CONTACT

713-745-5422

cchung3@mdanderson.org

Principal Investigator

Caroline Chung

PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Study Locations (Sites)

M D Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

Caroline Chung, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-06-05

Study Completion Date2027-02-02

Study Record Updates

Study Start Date2019-06-05

Study Completion Date2027-02-02

Terms related to this study

Additional Relevant MeSH Terms

Glioblastoma
WHO Grade II Glioma
WHO Grade III Glioma