ACTIVE_NOT_RECRUITING

Simulation-Based Caregiving Skills Training for Family Members of High Grade Glioma Patients

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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

Family caregivers of patients with a primary brain tumor experience a high caregiving load including assistance with activities of daily living without any formal training. It is not surprising that this vulnerable caregiver population reports high levels of distress along with numerous caregiving-related concerns, which may compromise their ability to provide quality care. This project will examine the feasibility and initial evidence for efficacy of a caregiving skills intervention aiming to improve caregiver and patient psychological health; caregiving efficacy and role adjustment; and reduce patient cancer-related symptoms and healthcare utilization.

Official Title

Simulation-Based Caregiving Skills Training for Family Members of High Grade Glioma Patients

Quick Facts

Study Start:2022-10-21

Study Completion:2026-08-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05511324

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
* FCGs (e.g., spouse/partner, parent, adult child) of patients diagnosed with HGG receiving any form of cancer treatment (including palliative intent) at MDACC. * Patients must have a Karnofsky Performance Status (KPS) of 100 to 50. If the patient's Karnofsky Performance Status drops below 50 both patient and caregiver will be removed from the study. * Both FCGs and patients must be willing to participate and (1) ≥18 years old and able to (2) read and speak English and (3) provide informed consent.	* FCGs who regularly participate in psychotherapy with a licensed professional (self-reported). * Patients with cognitive impairment that would impede ability to complete self-report surveys as documented in the medical record. * Children under the age of 18 will not be included in this trial. First and foremost, it is unlikely that a person under the age 18 is diagnosed with an HGG. * Childhood brain tumors tend to be diagnosed in infancy and the caregiving and symptom management needs are vastly different than in the adult patient population. Additionally, the assessment tools are not validated for minors. * While pregnant caregivers (self-reported) are study eligible, we will also exclude pregnant patients (medical notes). It is unlikely that patients diagnosed with an HGG will be pregnant. Moreover, the current caregiver intervention is not designed to address the care needs of pregnant cancer patients.

Inclusion Criteria

Exclusion Criteria

* FCGs (e.g., spouse/partner, parent, adult child) of patients diagnosed with HGG receiving any form of cancer treatment (including palliative intent) at MDACC.
* Patients must have a Karnofsky Performance Status (KPS) of 100 to 50. If the patient's Karnofsky Performance Status drops below 50 both patient and caregiver will be removed from the study.
* Both FCGs and patients must be willing to participate and (1) ≥18 years old and able to (2) read and speak English and (3) provide informed consent.

* FCGs who regularly participate in psychotherapy with a licensed professional (self-reported).
* Patients with cognitive impairment that would impede ability to complete self-report surveys as documented in the medical record.
* Children under the age of 18 will not be included in this trial. First and foremost, it is unlikely that a person under the age 18 is diagnosed with an HGG.
* Childhood brain tumors tend to be diagnosed in infancy and the caregiving and symptom management needs are vastly different than in the adult patient population. Additionally, the assessment tools are not validated for minors.
* While pregnant caregivers (self-reported) are study eligible, we will also exclude pregnant patients (medical notes). It is unlikely that patients diagnosed with an HGG will be pregnant. Moreover, the current caregiver intervention is not designed to address the care needs of pregnant cancer patients.

Contacts and Locations

Principal Investigator

Kathryn Milbury, MA,PHD

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

Kathryn Milbury, MA,PHD, 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 Date2022-10-21

Study Completion Date2026-08-31

Study Record Updates

Study Start Date2022-10-21

Study Completion Date2026-08-31

Terms related to this study

Additional Relevant MeSH Terms

Glioma