Caregiver Burden, Quality of Life, and Symptom Distress at Different Palliative Cancer Care Settings
NCT ID: NCT04186884
Last Updated: 2022-03-03
Study Results
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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COMPLETED
351 participants
OBSERVATIONAL
2019-03-26
2021-11-05
Brief Summary
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Detailed Description
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I. To compare the severity of subjective stress burden (emotional impact) between caregivers of patients seen at the Supportive Care Center (SCC) and those seen at the Palliative Care Unit (PCU) as measured by the Montgomery - Borgatta Caregiver Burden Scale.
SECONDARY OBJECTIVES:
I. To compare objective burden (impact on tangible aspects of life) between caregivers of patients seen at SCC and the PCU.
II. To compare subjective demand burden (impact on the patient-caregiver relationship) between caregivers of patients seen at the SCC and the PCU.
III. To compare caregiver quality of life (measured by the Short-form 36) and symptom distress (measured by the caregiver ESAS \[Edmonton Symptom Assessment System\]) between caregivers of patients seen at the SCC and the PCU.
IV. To examine if there is a correlation between caregiver burden (Montgomery-Borgatta scale), quality of life (Short-form 36 scale) and symptom distress (ESAS caregiver scale).
V. To determine which caregiver and/or patients' factors are associated with caregiver burden, quality of life, and symptom distress.
OUTLINE:
Patients and caregivers visiting SCC for a consult or admitted to PCU complete questionnaires over 35 minutes.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Observational (questionnaires)
Patients and caregivers visiting SCC for a consult or admitted to PCU complete questionnaires over 35 minutes.
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Complete questionnaires
Interventions
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Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Complete questionnaires
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. (SCC Patient) Patients who can identify a primary informal caregiver.
3. (SCC Patient) Diagnosis of advanced cancer defined as locally advanced, recurrent, or metastatic.
4. (SCC Patient) Be able to read and speak English.
5. (SCC Patient) 18 years of age or older.
6. (Caregiver of SCC Patient) Be identified or self-identified as a primary informal caregiver of the patient. The caregiver could be present or verbally agree to participate.
7. (Caregiver of SCC Patient) Be able to read and speak English.
8. (Caregiver of SCC Patient) 18 years of age or older.
9. (Caregiver of SCC Patient) Caregivers who are not able to complete the assessment on the day of patients' first consultation must be willing to engage in a telephone assessment with research staff +/- 3 days after.
10. (PCU Patient) Patients who have been admitted to the PCU at MD Anderson Cancer Center.
11. (PCU Patient) Patients should have a primary informal caregiver during their PCU stay.
12. (PCU Patient) Diagnosis of advanced cancer defined as locally advanced, recurrent, or metastatic.
13. (PCU Patient) Be able to read and speak English.
14. (PCU Patient) 18 years of age or older.
15. (Caregiver of PCU Patient) Be identified by the patient or self-identified as the primary informal caregiver of the patient. The caregiver should be present with the patient during PCU stay.
16. (Caregiver of PCU Patient) Be able to read and speak English.
17. (Caregiver of PCU Patient) 18 years of age or older.
Exclusion Criteria
2. (SCC Patient) Patients with only paid caregivers.
3. (SCC Patient) Patients with cognitive impairment as identified by research staff, treating physician or nurse.
4. (Caregiver of SCC Patient) Refusal to participate in this study. This study requires both patient and caregiver enrollment.
5. (Caregiver of SCC Patient) Patients with no caregivers or patients with only paid caregivers.
6. (PCU Patient) Refusal to participate in this study. This study requires both patient and caregiver enrollment.
7. (PCU Patient) Patients with no caregivers or patients with only paid caregivers.
8. (PCU Patient) Patients with cognitive impairment as identified by research staff, treating physician or nurse.
9. (Caregiver of PCU Patient) Refusal to participate in this study. This study requires both patient and caregiver enrollment.
10. (Caregiver of PCU Patient) Patients with no caregivers or patients with only paid caregivers.
18 Years
ALL
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Kimberson C Tanco
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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University of Texas MD Anderson Cancer Center Website
Other Identifiers
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NCI-2019-01197
Identifier Type: REGISTRY
Identifier Source: secondary_id
2018-0819
Identifier Type: OTHER
Identifier Source: secondary_id
2018-0819
Identifier Type: -
Identifier Source: org_study_id
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