- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04055948
Building Family Caregiver Skills Using a Simulation-Based Intervention for Care of Cancer Patients
Building Family Caregiver Skills Using a Simulation-Based Intervention for Care of Patients With Cancer
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Susan Mazanec, PhD
- Phone Number: 1-800-641-2422
- Email: CTUReferral@UHhospitals.org
Study Locations
-
-
Ohio
-
Cleveland, Ohio, United States, 44109
- Recruiting
- MetroHealth Medical Center
-
Contact:
- Peter M Laye, MD
- Phone Number: 216-778-5470
-
Principal Investigator:
- Peter M Laye, MD
-
Cleveland, Ohio, United States, 44106
- Recruiting
- University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
-
Contact:
- Susan Mazanec, PhD
- Phone Number: 800-641-2422
- Email: CTUReferral@UHhospitals.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control - Standard of Care
- All participants will be screened for health literacy using a 4-item Brief Health Literacy Screening Tool (BRIEF)
|
|
Experimental: Intervention
|
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 2 weeks post-treatment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CG anxiety at 20 weeks post-treatment
Time Frame: 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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CG anxiety at the end of radiation treatment
Time Frame: At end of treatment, average of seven weeks
|
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
|
CG anxiety at 4 weeks post treatment
Time Frame: 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
|
CG depression
Time Frame: at baseline, at end of treatment (average of seven weeks), and at 4 and 20 weeks post treatment
|
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
|
CG HRQOL as measured by PROMIS Global Health Scale Global Physical Health and Global Mental Health domains
Time Frame: at baseline, at end of treatment (average of seven weeks), and at 4 and 20 weeks post treatment
|
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
|
CG fatigue
Time Frame: at baseline, at end of treatment (average of seven weeks), and at 4 and 20 weeks post treatment
|
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
|
Participant HRQOL (cancer patient) as measured by FACT-C
Time Frame: at baseline, at end of treatment (average of seven weeks), and at 4 and 20 weeks post treatment
|
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
|
Participant HRQOL (cancer patient) as measured by FACT-H&N
Time Frame: at baseline, at end of treatment (average of seven weeks), and at 4 and 20 weeks post treatment
|
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
|
Participant HRQOL (cancer patient) as measured by FACT - E
Time Frame: at baseline, at end of treatment (average of seven weeks), and at 4 and 20 weeks post treatment
|
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
|
Participant HRQOL (cancer patient) as measured by FACT-L
Time Frame: at baseline, at end of treatment (average of seven weeks), and at 4 and 20 weeks post treatment
|
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
|
Interrupted treatment
Time Frame: At end of treatment, average of seven weeks
|
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
|
Healthcare utilization cost
Time Frame: at baseline, at end of treatment (average of seven weeks), and at 4 and 20 weeks post treatment
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Susan Mazanec, PhD, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CASE4Y19
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cancer
-
University of Michigan Rogel Cancer CenterRecruitingCancer Liver | Cancer Brain | Cancer Head &Neck | Cancer PelvisUnited States
-
Cellworks Group Inc.RecruitingCancer | Relapsed Cancer | Refractory CancerUnited States
-
Vanderbilt-Ingram Cancer CenterNational Institutes of Health (NIH)Active, not recruitingAdvanced Cancer | Relapsed Cancer | Refractory CancerUnited States
-
UNC Lineberger Comprehensive Cancer CenterHyundai Hope On WheelsRecruitingCancer | Pediatric Cancer | Survivorship | Cancer MetastaticUnited States
-
MiRXES Pte LtdRecruitingBreast Cancer | Gastric Cancer | Colorectal Cancer | Pancreatic Cancer | Esophageal Cancer | Ovarian Cancer | Prostate Cancer | Thoracic Cancer | Liver CancerSingapore
-
Sidney Kimmel Cancer Center at Thomas Jefferson...CompletedStage I Breast Cancer | Stage I Uterine Corpus Cancer | Stage II Uterine Corpus Cancer | Stage III Uterine Corpus Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage... and other conditionsUnited States
-
Massachusetts General HospitalNational Comprehensive Cancer NetworkCompletedGastric Cancer | Pancreatic Cancer | Esophageal Cancer | Rectal Cancer | Colon Cancer | Hepatobiliary CancerUnited States
-
Johns Hopkins UniversityNational Cancer Institute (NCI); National Institute on Minority Health and...Enrolling by invitationCancer | Advanced Cancer | End Stage Cancer | MalignancyUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)CompletedStage III Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IV Gastric Cancer | Stage IVA Colorectal Cancer | Stage IVA Pancreatic Cancer | Stage IVB Colorectal Cancer | Stage IVB Pancreatic Cancer | Stage IIIA Gastric Cancer | Stage IIIB Gastric Cancer | Stage IIIC Gastric... and other conditionsUnited States
-
Case Comprehensive Cancer CenterCompletedStage IIA Rectal Cancer | Stage IIB Rectal Cancer | Stage IIC Rectal Cancer | Stage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal Cancer | Stage IIIA Colon Cancer | Stage IIIB Colon Cancer | Stage IIIC Colon Cancer | Recurrent Colon Cancer | Recurrent Rectal Cancer | Stage IVA Colon Cancer | Stage IVA Rectal Cancer and other conditionsUnited States
Clinical Trials on One-on-one teaching sessions
-
Beth Israel Deaconess Medical CenterUnknown
-
Boston Medical CenterCompletedCirrhosis | AscitesUnited States
-
Heinrich HussleinCompleted
-
Case Comprehensive Cancer CenterNational Institute on Minority Health and Health Disparities (NIMHD)CompletedCancer Survivor | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage IIIC Breast CancerUnited States
-
Centre de Recherche de l'Institut Universitaire...Active, not recruitingUrinary Incontinence | Urinary Stress IncontinenceCanada
-
University of PittsburghNational Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health...CompletedOverweight and ObesityUnited States
-
Oregon Health and Science UniversityNational Cancer Institute (NCI); National Institute of Arthritis and Musculoskeletal...CompletedCardiovascular Diseases | Cancer | Physical Activity | NutritionUnited States
-
The Reading Hospital and Medical CenterCompletedAttitude of Health PersonnelUnited States
-
Universidad de ZaragozaCompletedCaregiver | Disabled Persons
-
VA Office of Research and DevelopmentCompletedStroke | Aphasia | Dyslexia, AcquiredUnited States