Abstract

TPS12129 Background: Positive treatment outcomes and avoidance of complications are dependent to a large extent on the care provided by family members. However, family caregivers report feeling unprepared to assume the multiple, complex tasks of caregiving, including tracheostomy care, tube feedings, wound and colostomy care, pain management, and emotional support. Despite being a critical extension of the oncology healthcare team, training of caregivers to manage symptoms, deal with communication issues with the care recipients, and take care of their own physical and emotional health as caregivers, is not integrated into clinical practice. The purpose of this clinical trial is to measure the effect of a psychoeducational caregiver intervention that incorporates simulation techniques focused on skill development to improve caregiver and patient outcomes. Simulation, commonly used in training healthcare professionals, is a form of experiential learning that creates events or situations to mimic clinical situations. Use of simulation for skills training in family caregivers of patients with cancer is rarely studied. Methods: This two-group, randomized clinical trial, which opened to accrual in December 2019, will recruit 180 caregivers from University Hospitals Seidman Cancer Center. Patients must be receiving radiation therapy for a diagnosis of stage I - III cancers of the rectum, anus, and esophagus; stage III NSCLC; or stage I – IV A/B head/neck cancer. Adult caregivers must be identified by the patient as their primary caregiver, who is providing daily assistance and/or emotional support. The intervention involves three in-person, one-on-one sessions during radiation treatments. The control group is usual care. Data will be collected at baseline, at the end of radiation treatment, and 4 and 20 weeks post-radiation treatment. The primary outcome is caregiver anxiety at 20 weeks postradiation treatment. Other caregiver outcomes include depression, health-related quality of life [HRQOL], and fatigue. Patient outcomes (HRQOL and interrupted treatment course) and healthcare utilization outcomes (unplanned hospital admission, emergency room visits, and use of intravenous fluids) will be measured. The analysis will consist of linear mixed model repeated measures, mediation and moderation tests, and Poisson regression methods. Clinical trial information: NCT04055948 .

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