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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2019-01197 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2018-0819 | Other Identifier | M D Anderson Cancer Center | |
| P30CA016672 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This trial studies caregiver burden, quality of life, and symptom distress of patients and their informal (unpaid) caregivers at different palliative care settings. Cancer caregiving may affect a caregiver's life physically, emotionally, socially, and financially. Studying caregiver burden may help investigators learn about caregivers' opinions on stress of caregiving, and about the factors related to caregiver burdens.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational (questionnaires) | Patients and caregivers visiting SCC for a consult or admitted to PCU complete questionnaires over 35 minutes. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quality-of-Life Assessment | Other | Ancillary studies |
|
| 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) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Objective burden (impact on tangible aspects of life Questionnaire | 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 |
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Inclusion Criteria
Exclusion Criteria
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Patients visiting the SCC for a first consultation or patients admitted to the PCU at MD Anderson Cancer Center and primary informal caregiver of patient
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| Name | Affiliation | Role |
|---|---|---|
| Kimberson C Tanco | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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| Questionnaire Administration | Other | Complete questionnaires |
|
| Day 1, day of enrollment |
| Subjective demand burden (impact on the patient-caregiver relationship) of caregivers | 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 | 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 | 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 | 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 |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
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