Grant Number:	5R37CA240707-06 Interpret this number
Primary Investigator:	Mazanec, Susan
Organization:	Case Western Reserve University
Project Title:	Building Family Caregiver Skills Using a Simulation-Based Intervention for Care of Patients with Cancer
Fiscal Year:	2024

Project Summary/Abstract: Patients with head and neck, lung, esophageal, rectal, and anal cancers typically undergo rigorous, intense, combined-modality treatment (radiation, surgery, and/or chemotherapy) and experience high symptom burden, functional impairment, and complex psychosocial issues. Positive treatment outcomes and avoidance of complications are dependent largely on the adequacy of care provided by family members. However, family caregivers (CGs) report feeling unprepared to assume the multiple, complex tasks of caregiving, including tangible help with tracheostomy care, tube feedings, wound and colostomy care, pain management, and ongoing emotional support. Despite being a critical extension of the oncology healthcare team, training of CGs to manage symptoms, deal with communication issues with care recipients, and take care of their own physical and emotional health, is not integrated into clinical practice. This study will measure the effect of a psychoeducational and skills training intervention that incorporates structured simulation or experiential learning to improve CG, patient, and healthcare utilization outcomes. Simulation is effective in training healthcare professionals, but little is known about its effectiveness in training family CGs. The intervention is designed for the period of active cancer treatment and the immediate transition to posttreatment survivorship, a time when the CG and patient are most vulnerable. The specific aims of this 2-group, prospective, randomized controlled trial are to: (1) evaluate the effect of a CG intervention, as compared to a control group, on CG primary (anxiety) and secondary (depression, health-related quality of life [HRQOL], and fatigue) outcomes; (2) measure the effect of the intervention on patient outcomes (HRQOL and interrupted treatment course) and healthcare utilization outcomes (unplanned hospital admission, unplanned emergency room visits, and unplanned use of intravenous fluids); (3) determine if CG self-efficacy mediates the effect of the intervention on CG anxiety; (4) determine if patient illness factors, care demands, and patient and CG demographic factors moderate the relationship between the intervention and CG outcomes; and (5) compare the costs of healthcare utilization between the intervention and control groups. We will recruit 180 CGs from University Hospitals Seidman Cancer Center at the Case Comprehensive Cancer Center. The intervention involves three in-person, one-on-one sessions during radiation treatments, followed by a telephone contact 2 weeks posttreatment. Data will be collected at baseline, at the end of radiation treatment, and 4 and 20 weeks postradiation treatment. The analysis will consist of linear mixed model repeated measures, mediation and moderation tests, and Poisson regression methods. The proposed project addresses National Cancer Institute's Division of Cancer Control and Population Sciences mission of improving the delivery of care to individuals and family members affected by cancer. The study findings will provide crucial information for translating the psychoeducational and simulation methods used in this intervention to other CG populations and clinical settings.





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