- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04186884
Caregiver Burden, Quality of Life, and Symptom Distress at Different Palliative Cancer Care Settings
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVE:
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- M D Anderson Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria
- ( SCC Patient) Patients visiting the SCC for a first consultation.
- (SCC Patient) Patients who can identify a primary informal caregiver.
- (SCC Patient) Diagnosis of advanced cancer defined as locally advanced, recurrent, or metastatic.
- (SCC Patient) Be able to read and speak English.
- (SCC Patient) 18 years of age or older.
- (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.
- (Caregiver of SCC Patient) Be able to read and speak English.
- (Caregiver of SCC Patient) 18 years of age or older.
- (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.
- (PCU Patient) Patients who have been admitted to the PCU at MD Anderson Cancer Center.
- (PCU Patient) Patients should have a primary informal caregiver during their PCU stay.
- (PCU Patient) Diagnosis of advanced cancer defined as locally advanced, recurrent, or metastatic.
- (PCU Patient) Be able to read and speak English.
- (PCU Patient) 18 years of age or older.
- (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.
- (Caregiver of PCU Patient) Be able to read and speak English.
- (Caregiver of PCU Patient) 18 years of age or older.
Exclusion Criteria
- (SCC Patient) Refusal to participate in this study. This study requires both patient and caregiver enrollment.
- (SCC Patient) Patients with only paid caregivers.
- (SCC Patient) Patients with cognitive impairment as identified by research staff, treating physician or nurse.
- (Caregiver of SCC Patient) Refusal to participate in this study. This study requires both patient and caregiver enrollment.
- (Caregiver of SCC Patient) Patients with no caregivers or patients with only paid caregivers.
- (PCU Patient) Refusal to participate in this study. This study requires both patient and caregiver enrollment.
- (PCU Patient) Patients with no caregivers or patients with only paid caregivers.
- (PCU Patient) Patients with cognitive impairment as identified by research staff, treating physician or nurse.
- (Caregiver of PCU Patient) Refusal to participate in this study. This study requires both patient and caregiver enrollment.
- (Caregiver of PCU Patient) Patients with no caregivers or patients with only paid caregivers.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Observational (questionnaires)
Patients and caregivers visiting SCC for a consult or admitted to PCU complete questionnaires over 35 minutes.
|
Ancillary studies
Other Names:
Complete questionnaires
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Severity of subjective stress burden (emotional impact) in caregivers of patients seen at the Supportive Care Center (SCC) and at the Palliative Care Unit (PCU)
Time Frame: Day 1, day of enrollment
|
Measured by the Montgomery-Borgatta Caregiver Burden Scale.
(4-item sub-scale questionnaire to measure the degree caregivers perceive their tasks and evaluates emotional effects of caregiving has a (Cronbach Alpha ranging from 0.68 to 0.82.)
|
Day 1, day of enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective burden (impact on tangible aspects of life Questionnaire
Time Frame: Day 1, day of enrollment
|
Measured by Montgomery-Borgatta Caregiver Burden Scale using the 6-item objective burden sub-scale questionnaire.
The sub-scale measure objective effects of caregiving in the caregivers life (i.e.:amount of time for personal privacy, recreational activities, time available to work, etc.) has a. Cronbach Alpha ranging from 0.87 to 0.90
|
Day 1, day of enrollment
|
Subjective demand burden (impact on the patient-caregiver relationship) of caregivers
Time Frame: Day 1, day of enrollment
|
Measured by Montgomery-Borgatta Caregiver Burden Scale using the 4-item subjective demand burden sub-scale questionnaire.
(ranges from 0.81 to 0.88)
|
Day 1, day of enrollment
|
Caregiver quality of life and symptoms of distress
Time Frame: Day 1, day of enrollment
|
Will compare caregiver quality of life (measured by the Short-form 36) and caregiver symptom distress (measured by the caregiver Edmonton Symptom Assessment System [ESAS]) between caregivers of patients seen at the SCC and the PCU between caregivers of patients seen at the SCC and the PCU.(Cronbach
Alpha ranges from 0.70 to 0.94)
|
Day 1, day of enrollment
|
Caregiver symptom distress
Time Frame: Day 1, day of enrollment
|
Will examine the correlation between caregiver burden (Montgomery-Borgatta scale), quality of life (Short-form 36 scale) and symptom distress (ESAS caregiver scale).
Explore if caregivers with higher burden will also have worse quality of life and higher symptom distress
|
Day 1, day of enrollment
|
Factors that are associated with caregiver burden, quality of life, and symptom distress Questionnaires
Time Frame: Day 1, day of enrollment
|
Explore the effect of patients'caregivers' demographics, comorbidities (Charlson Comorbidity Index), duration of care since diagnosis, strength of religious faith and engagement (Santa Clara Strength of Religious Faith Questionnaire), trust in medical profession (Trust in the Medical Profession Questionnaire with caregiver burden, quality of life, patients' demographics and/or symptom distress, clinical characteristics (comorbidities, performance status, symptom distress scores, delirium severity prognosis) on each of caregivers' burden, quality of life, and symptom distress.
Responses are summed and scores range from 5-25, with higher scores indicating higher trust
|
Day 1, day of enrollment
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Kimberson C Tanco, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-0819 (Other Identifier: M D Anderson Cancer Center)
- P30CA016672 (U.S. NIH Grant/Contract)
- NCI-2019-01197 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
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 Metastatic Malignant Neoplasm
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingAdvanced Malignant Solid Neoplasm | Metastatic Malignant Solid Neoplasm | Metastatic Malignant Neoplasm in the Liver | Metastatic Malignant Neoplasm in the LungUnited States
-
National Cancer Institute (NCI)Active, not recruitingAdvanced Malignant Solid Neoplasm | Metastatic Malignant Solid Neoplasm | Metastatic Malignant Neoplasm in the Liver | Unresectable Solid NeoplasmUnited States, Canada
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)CompletedMetastatic Malignant Neoplasm | Unresectable Malignant Neoplasm | Advanced Malignant NeoplasmUnited States
-
National Cancer Institute (NCI)RecruitingAdvanced Malignant Solid Neoplasm | Unresectable Malignant Solid Neoplasm | Metastatic Malignant Solid NeoplasmUnited States
-
National Cancer Institute (NCI)Active, not recruitingAdvanced Malignant Solid Neoplasm | Unresectable Malignant Solid Neoplasm | Metastatic Malignant Solid NeoplasmUnited States
-
National Cancer Institute (NCI)CompletedAdvanced Malignant Solid Neoplasm | Unresectable Malignant Solid Neoplasm | Metastatic Malignant Solid NeoplasmUnited States
-
National Cancer Institute (NCI)Active, not recruitingAdvanced Malignant Solid Neoplasm | Refractory Malignant Solid Neoplasm | Unresectable Malignant Solid Neoplasm | Metastatic Malignant Solid NeoplasmUnited States
-
M.D. Anderson Cancer CenterActive, not recruitingRefractory Malignant Solid Neoplasm | Unresectable Malignant Solid Neoplasm | Metastatic Malignant Solid NeoplasmUnited States
-
M.D. Anderson Cancer CenterWithdrawnLocally Advanced Malignant Solid Neoplasm | Recurrent Malignant Solid Neoplasm | Metastatic Malignant Solid Neoplasm | Metastatic Malignant Neoplasm in the Bone
-
National Cancer Institute (NCI)Active, not recruitingRefractory Malignant Solid Neoplasm | Unresectable Malignant Solid Neoplasm | Metastatic Malignant Solid NeoplasmUnited States
Clinical Trials on Quality-of-Life Assessment
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)CompletedUnspecified Adult Solid Tumor, Protocol Specific | Malignant NeoplasmUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)RecruitingChildhood Malignant NeoplasmUnited States, Canada, Puerto Rico, Australia, New Zealand
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedOvarian Clear Cell Cystadenocarcinoma | Ovarian Endometrioid Adenocarcinoma | Ovarian Seromucinous Carcinoma | Ovarian Serous Cystadenocarcinoma | Stage IV Ovarian Germ Cell Tumor | Ovarian Sarcoma | Malignant Ovarian Epithelial Tumor | Ovarian Carcinosarcoma | Ovarian Brenner Tumor | Ovarian Mucinous... and other conditionsUnited States
-
Wake Forest University Health SciencesWithdrawnLung Metastases | Extensive Stage Small Cell Lung Cancer | Recurrent Small Cell Lung Cancer | Recurrent Non-small Cell Lung Cancer | Stage IV Non-small Cell Lung Cancer | Recurrent Malignant Mesothelioma | Advanced Malignant Mesothelioma
-
City of Hope Medical CenterNational Cancer Institute (NCI)Recruiting
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingHematopoietic and Lymphoid Cell Neoplasm | Malignant Solid Neoplasm | COVID-19 InfectionUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingHematopoietic and Lymphoid Cell Neoplasm | Malignant Solid Neoplasm | COVID-19 InfectionUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingHematopoietic and Lymphoid Cell Neoplasm | Malignant Solid Neoplasm | Neuropathy | COVID-19 InfectionUnited States
-
M.D. Anderson Cancer CenterActive, not recruitingCervical Carcinoma | Endometrial Carcinoma | Vaginal Carcinoma | Malignant Female Reproductive System Neoplasm | Vulvar CarcinomaUnited States
-
Academic and Community Cancer Research UnitedNational Cancer Institute (NCI)Active, not recruitingMetastatic Colorectal Carcinoma | Stage IV Colorectal Cancer AJCC v8 | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC v8 and other conditionsUnited States