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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

242 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-17

Study Completion Date

2025-02-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patient and family caregiver dyads are enrolled in this 2-group, prospective, randomized controlled design to test the effect of a caregiver intervention during radiation therapy.

The study enrolled a total of 242 dyads(484 participants)

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Research Assistant (RA) will be blind to which group CG is assigned.

Study Groups

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Control - Standard of Care

CG(caregivers)/CP(cancer patients) dyads

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention

CG/CP dyads

* 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.

Group Type EXPERIMENTAL

One-on-one teaching sessions

Intervention Type BEHAVIORAL

One-on-one teaching sessions with the caregiver during radiation treatments. (note - intervention sessions 2 \& 3 delivered by phone during COVID-19)

Telephone booster contact

Intervention Type BEHAVIORAL

Telephone booster contact 2 weeks post-treatment.

Interventions

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One-on-one teaching sessions

One-on-one teaching sessions with the caregiver during radiation treatments. (note - intervention sessions 2 \& 3 delivered by phone during COVID-19)

Intervention Type BEHAVIORAL

Telephone booster contact

Telephone booster contact 2 weeks post-treatment.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.

* 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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No