Clinical trial NCT04055948: Building Family Caregiver Skills Using a Simulation-Based Intervention for Care of Cancer Patients
Official title: Building Family Caregiver Skills Using a Simulation-Based Intervention for Care of Patients With Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cancer
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-08-14
Enrollment: 488
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization will be done using the minimization stratified randomization technique (QMinim). Stratification variables will be CG gender, CG age, and patient cancer type.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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.

Eligibility 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).

Primary outcomes:
measure: CG anxiety at 20 weeks post-treatment
timeFrame: 20 weeks post treatment
Secondary outcomes:
measure: CG anxiety at the end of radiation treatment
timeFrame: At end of treatment, average of seven weeks
measure: CG anxiety at 4 weeks post treatment
timeFrame: 4 weeks post treatment
measure: CG depression
timeFrame: at baseline, at end of treatment (average of seven weeks), and at 4 and 20 weeks post treatment
measure: CG HRQOL as measured by PROMIS Global Health Scale Global Physical Health and Global Mental Health domains
timeFrame: at baseline, at end of treatment (average of seven weeks), and at 4 and 20 weeks post treatment
measure: CG fatigue
timeFrame: at baseline, at end of treatment (average of seven weeks), and at 4 and 20 weeks post treatment
measure: Participant HRQOL (cancer patient) as measured by FACT-C
timeFrame: at baseline, at end of treatment (average of seven weeks), and at 4 and 20 weeks post treatment
measure: Participant HRQOL (cancer patient) as measured by FACT-H&N
timeFrame: at baseline, at end of treatment (average of seven weeks), and at 4 and 20 weeks post treatment
measure: Participant HRQOL (cancer patient) as measured by FACT - E
timeFrame: at baseline, at end of treatment (average of seven weeks), and at 4 and 20 weeks post treatment
measure: Participant HRQOL (cancer patient) as measured by FACT-L
timeFrame: at baseline, at end of treatment (average of seven weeks), and at 4 and 20 weeks post treatment
measure: Interrupted treatment
timeFrame: At end of treatment, average of seven weeks
measure: Healthcare utilization cost
timeFrame: at baseline, at end of treatment (average of seven weeks), and at 4 and 20 weeks post treatment
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
state: Ohio
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
name: Susan Mazanec, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mazanec SR, Blackstone E, Daly BJ. Building family caregiver skills using a simulation-based intervention for care of patients with cancer: protocol for a randomized controlled trial. BMC Nurs. 2021 Jun 9;20(1):93. doi: 10.1186/s12912-021-00612-4.