Caregiver Burden, Quality of Life, and Symptom Distress at Different Palliative Cancer Care Settings
3 other identifiers
observational
351
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 26, 2019
CompletedFirst Submitted
Initial submission to the registry
March 28, 2019
CompletedFirst Posted
Study publicly available on registry
December 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 5, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 5, 2021
CompletedMarch 3, 2022
March 1, 2022
2.6 years
March 28, 2019
March 2, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (5)
Objective burden (impact on tangible aspects of life Questionnaire
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
Caregiver symptom distress
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 Arms (1)
Observational (questionnaires)
Patients and caregivers visiting SCC for a consult or admitted to PCU complete questionnaires over 35 minutes.
Interventions
Ancillary studies
Eligibility Criteria
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
You may qualify if:
- ( 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.
- +2 more criteria
You may not qualify if:
- (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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kimberson C Tanco
M.D. Anderson Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 28, 2019
First Posted
December 5, 2019
Study Start
March 26, 2019
Primary Completion
November 5, 2021
Study Completion
November 5, 2021
Last Updated
March 3, 2022
Record last verified: 2022-03