Building Family Caregiver Skills Using a Simulation-Based Intervention for Care of Cancer Patients
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| ClinicalTrials.gov Identifier: NCT04055948 |
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Recruitment Status :
Recruiting
First Posted : August 14, 2019
Last Update Posted : November 15, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cancer | Behavioral: One-on-one teaching sessions Behavioral: Telephone booster contact | Not Applicable |
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 : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 180 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| 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. |
| Masking: | Single (Investigator) |
| Masking Description: | Research Assistant (RA) will be blind to which group CG is assigned. |
| Primary Purpose: | Supportive Care |
| Official Title: | Building Family Caregiver Skills Using a Simulation-Based Intervention for Care of Patients With Cancer |
| Actual Study Start Date : | December 17, 2019 |
| Estimated Primary Completion Date : | April 2023 |
| Estimated Study Completion Date : | October 2023 |
| Arm | Intervention/treatment |
|---|---|
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No Intervention: Control - Standard of Care
- All participants will be screened for health literacy using a 4-item Brief Health Literacy Screening Tool (BRIEF)
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Experimental: Intervention
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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) Behavioral: Telephone booster contact Telephone booster contact 2 weeks post-treatment. |
- 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.
- 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.
- 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.
- 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.
- 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
- 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.
- 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.
- 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
- 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)
- 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)
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04055948
| Contact: Susan Mazanec, PhD | 1-800-641-2422 | CTUReferral@UHhospitals.org |
| United States, Ohio | |
| University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center | Recruiting |
| Cleveland, Ohio, United States, 44106 | |
| Contact: Susan Mazanec, PhD 800-641-2422 CTUReferral@UHhospitals.org | |
| Principal Investigator: | Susan Mazanec, PhD | University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center |
| Responsible Party: | Case Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT04055948 |
| Other Study ID Numbers: |
CASE4Y19 |
| First Posted: | August 14, 2019 Key Record Dates |
| Last Update Posted: | November 15, 2022 |
| Last Verified: | November 2022 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |