Building Family Caregiver Skills Using a Simulation-Based Intervention for Care of Cancer Patients

Case Comprehensive Cancer Center (Case CCC)

Status: Enrolling

Conditions: Cancer

Treatments: Behavioral: Telephone booster contact; Behavioral: One-on-one teaching sessions

Study type: Interventional

Funder types: Other

Identifiers

NCT04055948

CASE4Y19

Details and patient eligibility

About

The purpose of this study is to learn whether an education and support program can help caregivers feel more confident in technical and communication skills needed to care for a person with cancer. Patients with cancer and their caregivers face many challenges. These include learning about cancer and its treatment, coping with symptoms from illness and treatment side effects, making adjustments to usual activities, and managing the emotional effects of having a serious illness. This study is testing whether different forms of education and support can help caregivers feel better prepared. To find out if education about caregiving and different kinds of support are effective, study personnel will compare approaches to help find ways to improve the services that are provided to caregivers during cancer treatment. About 180 patients and their caregivers at the Seidman Cancer Center will take part in this study. Participating in research is voluntary and this study is funded by the National Institute of Health.

Full description

This is a 2-group, prospective, randomized controlled design to test the effect of an intervention, as compared to a usual care control group, on family caregivers (CG) outcomes, patient outcomes, and healthcare utilization outcomes during treatment.

The objectives of this study are to:

• 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.
• 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).
• Determine if CG self-efficacy mediates the effect of the intervention on CG anxiety.
• 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.
• 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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria (for patients):

• Diagnosis of stage I, II, III cancers of the rectum, anus, and esophagus; stage III NSCLC; and stage I - IV A/B head/neck (tongue, gum, oral cavity, nasopharynx, oropharynx, hypopharynx, parotid, or larynx).
• Receiving their first course of radiation therapy.
• Has an identified family CG who is willing to participate.

Inclusion Criteria (for CGs):

• Family member or friend of an adult patient described above; and
• Identified by the patient as his/her primary CG, who is providing daily assistance and/or emotional support.

Exclusion Criteria:

• Patients who do not have a caregiver will be excluded.
• CGs of patients who are receiving hospice care will be excluded because of the patient's poor prognosis and multiple issues associated with end-of-life care.
• CGs who are themselves undergoing active cancer treatment will be excluded (hormonal treatment allowed).

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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180 participants in 2 patient groups

Control - Standard of Care

No Intervention group

Description:

- All participants will be screened for health literacy using a 4-item Brief Health Literacy Screening Tool (BRIEF)

Intervention

Experimental group

Description:

* All participants will be screened for health literacy using a 4-item Brief Health Literacy Screening Tool (BRIEF) * Three in-person, one-on-one teaching sessions with the caregiver during radiation treatments, followed by a telephone booster contact 2 weeks post-treatment.

Treatment:

Behavioral: One-on-one teaching sessions

Behavioral: Telephone booster contact