This trial studies how well a simulation-based education and support program works in improving caregiver skills for care of patients with cancer. Participating in an education and support program may help caregivers feel more confident in technical and communication skills needed to care for cancer patients.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04055948.
PRIMARY OBJECTIVES:
I. Evaluate the effect of a caregiver (CG) intervention, as compared to a control group, on CG primary (anxiety) and secondary (depression, health-related quality of life [HRQOL], and fatigue) outcomes.
II. 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).
III. Determine if CG self-efficacy mediates the effect of the intervention on CG anxiety.
IV. 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.
IVa. Examine which social determinants of health (aspects of vulnerability) in caregivers moderate the efficacy of the intervention;
IVb. Explore caregivers’ perspectives and experiences regarding the intervention to understand how the intervention should be modified to better serve vulnerable caregivers.
V. 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.
OUTLINE: Participants are randomized to 1 of 2 groups.
GROUP I: Caregivers participate in 3 30-minute one-on-one teaching sessions in person or by phone at 1, 3, and 6-8 weeks of patient radiation treatment and receive a telephone booster call at 2 weeks post treatment. Participants also receive usual care consisting of 10-15 minute visits weekly with the radiation oncologist and clinic nurse.
GROUP II: Caregivers receive usual care consisting of an educational booklet about care giving. Participants also receive usual care consisting of 10-15 minute visits weekly with the radiation oncologist and clinic nurse.
After completion of study, participants are followed up 4 and 20 weeks post radiation treatment.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationCase Comprehensive Cancer Center
Principal InvestigatorSusan Mazanec
