NCT05511324

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

Trial 1 (single-arm study) • Aim 1: Examine the usability of the intervention content and trial assessments in 10 caregiver-patient dyads to refine study procedures as needed. Trial 2 (RCT) Aim 1 (primary aim): Determine the feasibility of implementing a caregiving intervention using a randomized controlled design in 50 caregiver-HGG patient dyads. Aim 2: Evaluate the initial evidence for intervention efficacy relative to a WLC group regarding patient and caregiver psychological symptoms (primary outcome), caregiver caregiving efficacy and role adjustment, and patient cancer-related symptoms and healthcare utilization (secondary outcomes). Aim 3: Understand caregivers' experiences using qualitative methods regarding participation in this study and explore emerging themes as possible intervention mediators/moderators to be examined in future research.

Conditions

• Glioma

Interventions

Type	Name	Description
BEHAVIORAL	Questionnaires	Participants will be asked to complete this assessment on your own time, and it should take about 40 minutes.
BEHAVIORAL	Caregiver Assessment	These sessions will involve simulation-based, caregiving skill training, and your caregiver will be taught skills to help support you (such as feeding, hygiene, mobility, medication administration, and care coordination).

Timeline

• Start date: 2022-10-21
• Primary completion: 2026-08-31
• Completion: 2026-08-31
• First posted: 2022-08-22
• Last updated: 2026-02-19

Locations

1 site across 1 country: United States