R21CA273782

Simulation-Based Caregiving Skills Training for Family Members of High Grade Glioma Patients - Project Summary/Abstract

Patients with brain tumors experience more debilitating sequelae compared to other cancer patients and thus, often depend on their family members for care and support early on in the disease course. While caregiving-related activities are taxing in general, family caregivers of brain tumor patients face unique challenges related to patient cognitive decline, neurological and motor deficits, and personality changes due to the disease process and treatment.

With the typical rapid disease progression and subsequent patient functional decline, caregivers increasingly assist patients with activities of daily living (e.g., bathing, feeding, dressing) as well as coordination of care, symptom and medication management, and decision-making. Essentially, caregivers provide basic nursing care without skill-based training.

Moreover, despite clear evidence of high caregiver distress and burden, which may impact their ability to care for the patient, caregivers report that their support needs are often unattended to by multi-disciplinary oncology teams. In fact, the neuro-oncology literature generally lacks evidence-based supportive care interventions for this vulnerable population.

To address these critical knowledge gaps, we propose to pilot-test a novel simulation-based caregiving skills intervention to target the unique needs of caregivers. Given interdependence in distress and quality of life in families coping with cancer, we expect that this caregiver-focused intervention will improve not only caregiver but also patient outcomes.

Using a randomized controlled trial (RCT) design, patient-caregiver dyads will be randomized to the intervention or a waitlist control (WLC) arm. The intervention content will be delivered via three modes: education materials (i.e., workbook and video), two simulation-based caregiving skills training sessions, and two psychoeducation sessions addressing coping with caregiving-related role changes. The four manualized sessions will be nurse-led and tailored to the needs of the family's current situation using a needs assessment-driven approach.

Patients and caregivers will complete self-report measures at baseline (prior to randomization) and 6 and 12 weeks later. We will assess patient and caregiver psychological symptoms, caregiver efficacy and role adjustment, and patient cancer-related symptoms as intervention outcomes. Because psychological distress in caregivers is associated with increased preventable healthcare utilization, we will abstract emergency department visits, hospital admissions, and unplanned oncologist visits from patients' medical records.

We will integrate qualitative accounts of the caregivers' experiences with the multi-model intervention components. Feasibility data regarding consent, retention, adherence, and program evaluation will be recorded.

The proposed work will provide rich pilot data that will inform a subsequent larger trial for formal efficacy testing of this innovative intervention seeking to improve cancer-related burden in this vulnerable yet understudied patient-caregiver population.

The Univeristy Of Texas M.D. Anderson Cancer Center

TO IDENTIFY CANCER RISKS AND RISK REDUCTION STRATEGIES, TO IDENTIFY FACTORS THAT CAUSE CANCER IN HUMANS, AND TO DISCOVER AND DEVELOP MECHANISMS FOR CANCER PREVENTION AND PREVENTIVE INTERVENTIONS IN HUMANS. RESEARCH PROGRAMS INCLUDE: (1) CHEMICAL, PHYSICAL AND MOLECULAR CARCINOGENESIS, (2) SCREENING, EARLY DETECTION AND RISK ASSESSMENT, INCLUDING BIOMARKER DISCOVERY, DEVELOPMENT AND VALIDATION, (3) EPIDEMIOLOGY, (4) NUTRITION AND BIOACTIVE FOOD COMPONENTS, (5) IMMUNOLOGY AND VACCINES, (6) FIELD STUDIES AND STATISTICS, (7) CANCER CHEMOPREVENTION AND INTERCEPTION, (8) PRE-CLINICAL AND CLINICAL AGENT DEVELOPMENT, (9) ORGAN SITE STUDIES AND CLINICAL TRIALS, (10) HEALTH-RELATED QUALITY OF LIFE AND PATIENT-CENTERED OUTCOMES, AND (11) SUPPORTIVE CARE AND MANAGEMENT OF SYMPTOMS AND TOXICITIES. SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM: TO EXPAND AND IMPROVE THE SBIR PROGRAM, TO STIMULATE TECHNICAL INNOVATION, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT FUNDING, TO INCREASE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION IN INNOVATION AND ENTREPRENEURSHIP BY WOMEN AND SOCIALLY/ECONOMICALLY DISADVANTAGED PERSONS. SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM: TO STIMULATE AND FOSTER SCIENTIFIC AND TECHNOLOGICAL INNOVATION THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO FOSTER TECHNOLOGY TRANSFER THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT FUNDING, AND FOSTER PARTICIPATION IN INNOVATION AND ENTREPRENEURSHIP BY WOMEN AND SOCIALLY/ECONOMICALLY DISADVANTAGED PERSONS.

93.393 - Cancer Cause and Prevention Research

National Cancer Institute (NCI) [HHS - NIH]

Texas United States

State-Wide

Intervening with Cancer Caregivers to Improve Patient Health Outcomes and Optimize Health Care Utilization (R21 Clinical Trial Optional) (PAR-19-355)

Amendment Since initial award the End Date has been extended from 08/31/24 to 08/31/25 and the total obligations have increased 109% from $202,910 to $424,713.