||1R37CA240707-01 Interpret this number
||Case Western Reserve University
||Building Family Caregiver Skills Using a Simulation-Based Intervention for Care of Patients with Cancer
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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