NCT04055948

Building Family Caregiver Skills Using a Simulation-Based Intervention for Care of Cancer Patients

Building Family Caregiver Skills Using a Simulation-Based Intervention for Care of Patients With Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 484 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to learn whether an education and support program can help caregivers feel more confident in technical and communication skills needed to care for a person with cancer. Patients with cancer and their caregivers face many challenges. These include learning about cancer and its treatment, coping with symptoms from illness and treatment side effects, making adjustments to usual activities, and managing the emotional effects of having a serious illness. This study is testing whether different forms of education and support can help caregivers feel better prepared. To find out if education about caregiving and different kinds of support are effective, study personnel will compare approaches to help find ways to improve the services that are provided to caregivers during cancer treatment. About 180 patients and their caregivers at the Seidman Cancer Center will take part in this study. Participating in research is voluntary and this study is funded by the National Institute of Health.

Detailed description

This is a 2-group, prospective, randomized controlled design to test the effect of an intervention, as compared to a usual care control group, on family caregivers (CG) outcomes, patient outcomes, and healthcare utilization outcomes during treatment. The objectives of this study are to: * Evaluate the effect of a CG intervention, as compared to a control group, on CG primary (anxiety) and secondary (depression, HRQOL, and fatigue) outcomes. * Measure the effect of the intervention, as compared to a control group, on patient outcomes (HRQOL and interrupted treatment course), and healthcare utilization outcomes (unplanned hospital admissions, unplanned emergency room visits, and unplanned use of intravenous \[IV\] fluids). * Determine if CG self-efficacy mediates the effect of the intervention on CG anxiety. * Determine if patient illness factors, care demands (hours per week spent caregiving), and patient and CG demographic factors moderate the relationship between the intervention and CG outcomes. * Compare the costs of healthcare utilization (unplanned hospital admission, unplanned emergency room visits, and unplanned use of IV fluids) between the intervention and control groups.

Conditions

• Cancer

Interventions

Type	Name	Description
BEHAVIORAL	One-on-one support/educational sessions	One-on-one support/educational sessions with the caregiver during radiation treatments (note - intervention sessions 2 \& 3 delivered by phone during COVID-19 and remained an option after the pandemic).
BEHAVIORAL	Telephone booster contact	Telephone booster contact 2 weeks post-treatment.

Timeline

• Start date: 2019-12-17
• Primary completion: 2025-02-01
• Completion: 2025-02-01
• First posted: 2019-08-14
• Last updated: 2026-03-30
• Results posted: 2026-03-09

Locations

2 sites across 1 country: United States