Training family caregivers of patients with high-grade glioma
Simulation-Based Caregiving Skills Training for Family Members of High Grade Glioma Patients
This study is testing a training program for family caregivers of patients with high-grade glioma to see if it helps them feel more confident and improves the well-being of both the caregivers and the patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT05511324 on ClinicalTrials.gov |
What this trial studies
This project focuses on providing skills training to family caregivers of patients diagnosed with high-grade glioma, who often face significant caregiving challenges without formal training. The study will assess the feasibility and initial efficacy of a caregiving intervention aimed at improving both caregiver and patient psychological health, caregiving efficacy, and reducing patient cancer-related symptoms. The intervention will involve a randomized controlled design with caregiver-patient dyads, utilizing questionnaires and caregiver assessments to gather data on outcomes. Additionally, qualitative methods will be employed to explore caregivers' experiences and identify potential mediators of the intervention's effectiveness.
Who should consider this trial
Good fit: Ideal candidates include family caregivers of patients diagnosed with high-grade glioma who are currently receiving any form of cancer treatment.
Not a fit: Patients with cognitive impairments that hinder their ability to complete self-report surveys may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could enhance the psychological well-being of caregivers and improve the quality of care provided to patients with high-grade glioma.
How similar studies have performed: Other studies have shown promise in caregiver training interventions, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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. Exclusion Criteria: * 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.
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Kathryn Milbury, MA,PHD — M.D. Anderson Cancer Center
- Study coordinator: Kathryn Milbury, MA,PHD
- Email: kmilbury@mdanderson.org
- Phone: (713) 745-2868
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.