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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04055948
• Other study ID #: CASE4Y19
• Status: Recruiting
• Phase: N/A
• Start date: December 17, 2019
• Est. completion date: June 30, 2025

Study information

• Verified date: September 2023
• Source: Case Comprehensive Cancer Center
• Contact: Susan Mazanec, PhD
• Phone: 1-800-641-2422
• Email: CTUReferral[@]UHhospitals.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Cancer

Intervention

Behavioral:
• 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)
• Telephone booster contact
Telephone booster contact 2 weeks post-treatment.

Locations

Country	Name	City	State
United States	MetroHealth Medical Center	Cleveland	Ohio
United States	University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CG anxiety at 20 weeks post-treatment	Difference in CG anxiety between the intervention and control groups at 20 weeks post-radiation treatment.; CG anxiety will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Short Form 7a. This 7-item questionnaire assesses self-reported fear, worry, anxiety, tension, nervousness, and restlessness in the family caregiver over the last 7 days.; This outcome will be reporting the average T-score for anxiety as measured by the PROMIS scale. Raw scores range from 7 to 35. Each participant's raw score on the scale will be converted to a standardized T-score that has a mean of 50 and a standard deviation of 10. A higher T-score represents greater anxiety. For example, a T-score of 60 is one standard deviation worse anxiety than average.	20 weeks post treatment
Secondary	CG anxiety at the end of radiation treatment	Difference in CG anxiety between the intervention and control groups at the end of radiation treatment; CG anxiety will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Short Form 7a. This 7-item questionnaire assesses self-reported fear, worry, anxiety, tension, nervousness, and restlessness in the family caregiver over the last 7 days.; This outcome will be reporting the average T-score for anxiety as measured by the PROMIS scale. Raw scores range from 7 to 35. Each participant's raw score on the scale will be converted to a standardized T-score that has a mean of 50 and a standard deviation of 10. A higher T-score represents greater anxiety. For example, a T-score of 60 is one standard deviation worse anxiety than average.	At end of treatment, average of seven weeks
Secondary	CG anxiety at 4 weeks post treatment	CG anxiety between the intervention and control groups at 4 weeks post treatment.; CG anxiety will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Short Form 7a. This 7-item questionnaire assesses self-reported fear, worry, anxiety, tension, nervousness, and restlessness in the family caregiver over the last 7 days.; This outcome will be reporting the average T-score for anxiety as measured by the PROMIS scale. Raw scores range from 7 to 35. Each participant's raw score on the scale will be converted to a standardized T-score that has a mean of 50 and a standard deviation of 10. A higher T-score represents greater anxiety. For example, a T-score of 60 is one standard deviation worse anxiety than average.	4 weeks post treatment
Secondary	CG depression	CG depression will be measured with the PROMIS Depression Short Form 8b. This 8-item questionnaire assesses caregiver self-reported negative mood (sadness, guilt), views of self (worthlessness), and social cognition (loneliness), as well as decreased positive affect and engagement. It assesses depression over the last 7 days.; This outcome will be reporting the average T-score for depression as measured by the PROMIS scale. Raw scores range from 8 to 40. Each participant's raw score on the scale will be converted to a standardized T-score that has a mean of 50 and a standard deviation of 10. A higher T-score represents greater depression. For example, a T-score of 60 is one standard deviation worse depression than average.	at baseline, at end of treatment (average of seven weeks), and at 4 and 20 weeks post treatment
Secondary	CG HRQOL as measured by PROMIS Global Health Scale Global Physical Health and Global Mental Health domains	The PROMIS Global Health Scale will be scored as two separate domains - Global Physical Health and Global Mental Health. These domains are not combined for a total score. Raw scores range from 4 to 20. Each participant's raw score on the scale will be converted to a standardized T-score that has a mean of 50 and a standard deviation of 10. A higher T-score represents better health (Global Physical Health or Global Mental Health) than the general population. For example, a T-score of 60 is one standard deviation better health than average	at baseline, at end of treatment (average of seven weeks), and at 4 and 20 weeks post treatment
Secondary	CG fatigue	CG fatigue will be measured with the PROMIS Fatigue Short Form 7a, a 7-item questionnaire that evaluates the self-reported experience of fatigue (frequency, duration, intensity) and the impact of fatigue on daily activities. It assesses fatigue over the last 7 days.; This outcome will be reporting the average T-score for fatigue. Raw scores range from 7 to 35. Each participant's raw score on the scale will be converted to a standardized T-score that has a mean of 50 and a standard deviation of 10. A higher T-score represents greater fatigue. For example, a T-score of 60 is one standard deviation worse fatigue than average.	at baseline, at end of treatment (average of seven weeks), and at 4 and 20 weeks post treatment
Secondary	Participant HRQOL (cancer patient) as measured by FACT-C	Participant HRQOL will be measured using the disease-specific versions of FACT-G that include common subscales (physical, social, emotional, and functional well-being) plus cancer-specific questions. The effect of the intervention on HRQOL across diagnoses will be analyzed using the common subscales. The symptom experience with each diagnostic group will be described using the cancer-specific subscale.; Participants rate their response to each item on a 5-point Likert-type scale. After reverse-scoring negatively worded questions, items are summed. Higher scores indicate better quality of life.; The FACT - Colorectal (FACT-C, Version 4) is a 37-item questionnaire that measures self-reported HRQOL in patients with colorectal cancer over the last 7 days.	at baseline, at end of treatment (average of seven weeks), and at 4 and 20 weeks post treatment
Secondary	Participant HRQOL (cancer patient) as measured by FACT-H&N	Participant HRQOL will be measured using the disease-specific versions of FACT-G that include common subscales (physical, social, emotional, and functional well-being) plus cancer-specific questions. The effect of the intervention on HRQOL across diagnoses will be analyzed using the common subscales. The symptom experience with each diagnostic group will be described using the cancer-specific subscale.; Participants rate their response to each item on a 5-point Likert-type scale. After reverse-scoring negatively worded questions, items are summed. Higher scores indicate better quality of life.; The FACT - Head & Neck Scale (FACT-H&N, Version 4) is a 39-item questionnaire that assesses self-reported HRQOL in patients with head & neck cancer over the last 7 days	at baseline, at end of treatment (average of seven weeks), and at 4 and 20 weeks post treatment
Secondary	Participant HRQOL (cancer patient) as measured by FACT - E	Participant HRQOL will be measured using the disease-specific versions of FACT-G that include common subscales (physical, social, emotional, and functional well-being) plus cancer-specific questions. The effect of the intervention on HRQOL across diagnoses will be analyzed using the common subscales and will describe the symptom experience within each diagnostic group using the cancer-specific subscale.; Participants rate their response to each item on a 5-point Likert-type scale. After reverse-scoring negatively worded questions, items are summed. Higher scores indicate better quality of life.; The FACT - Esophageal (FACT-E)	at baseline, at end of treatment (average of seven weeks), and at 4 and 20 weeks post treatment
Secondary	Participant HRQOL (cancer patient) as measured by FACT-L	Participant HRQOL will be measured using the disease-specific versions of FACT-G that include common subscales (physical, social, emotional, and functional well-being) plus cancer-specific questions. The effect of the intervention on HRQOL across diagnoses will be analyzed using the common subscales and will describe the symptom experience within each diagnostic group using the cancer-specific subscale.; Participants rate their response to each item on a 5-point Likert-type scale. After reverse-scoring negatively worded questions, items are summed. Higher scores indicate better quality of life.; The FACT - Lung (FACT-L)	at baseline, at end of treatment (average of seven weeks), and at 4 and 20 weeks post treatment
Secondary	Interrupted treatment	Interrupted Radiation Treatment Course, defined as the total number of missed treatment days due to patient or caregiver reasons, will be determined from the patient's radiation therapy treatment record. Number of days of each episode of absence from treatment will also be recorded.	At end of treatment, average of seven weeks
Secondary	Healthcare utilization cost	Healthcare utilization includes unplanned hospital admission, unplanned emergency room visits, and unplanned IV fluid use for treatment of dehydration.; These variables will be combined to compute a "healthcare utilization cost" for each participant. Medicare reimbursement rates will be used to estimate costs regardless of the age or insurance of the participant. Using the DRG, diagnosis and procedure codes we will determine what Medicare "would have paid" for those services, and will use that as a proxy for cost. Cost of IV fluids will be estimated using wholesale acquisition cost. Mean differences between the intervention and control groups will be analyzed using a two sample t-test for independent means.	at baseline, at end of treatment (average of seven weeks), and at 4 and 20 weeks post treatment