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Clinical Trials/NCT04186884
NCT04186884
Completed
Not Applicable

Caregiver Burden, Quality of Life, and Symptom Distress at Different Palliative Cancer Care Settings

M.D. Anderson Cancer Center1 site in 1 country351 target enrollmentMarch 26, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Advanced Malignant Neoplasm
Sponsor
M.D. Anderson Cancer Center
Enrollment
351
Locations
1
Primary Endpoint
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)
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
March 26, 2019
End Date
November 5, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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.)

Secondary Outcomes

  • Caregiver symptom distress(Day 1, day of enrollment)
  • Subjective demand burden (impact on the patient-caregiver relationship) of caregivers(Day 1, day of enrollment)
  • Caregiver quality of life and symptoms of distress(Day 1, day of enrollment)
  • Objective burden (impact on tangible aspects of life Questionnaire(Day 1, day of enrollment)
  • Factors that are associated with caregiver burden, quality of life, and symptom distress Questionnaires(Day 1, day of enrollment)

Study Sites (1)

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