Clinical trial NCT04186884: Caregiver Burden, Quality of Life, and Symptom Distress at Different Palliative Cancer Care Settings
Official title: Caregiver Burden, Quality of Life, and Symptom Distress at Different Palliative Cancer Care Settings
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Advanced Malignant Neoplasm
Locally Advanced Malignant Neoplasm
Metastatic Malignant Neoplasm
Recurrent Malignant Neoplasm
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-12-05
Enrollment: 351
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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.

Eligibility criteria: Inclusion Criteria

1. ( SCC Patient) Patients visiting the SCC for a first consultation.
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

1. (SCC Patient) Refusal to participate in this study. This study requires both patient and caregiver enrollment.
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.

Primary outcomes:
measure: 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)
timeFrame: Day 1, day of enrollment
Secondary outcomes:
measure: Objective burden (impact on tangible aspects of life Questionnaire
timeFrame: Day 1, day of enrollment
measure: Subjective demand burden (impact on the patient-caregiver relationship) of caregivers
timeFrame: Day 1, day of enrollment
measure: Caregiver quality of life and symptoms of distress
timeFrame: Day 1, day of enrollment
measure: Caregiver symptom distress
timeFrame: Day 1, day of enrollment
measure: Factors that are associated with caregiver burden, quality of life, and symptom distress Questionnaires
timeFrame: Day 1, day of enrollment
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Kimberson C Tanco
role: PRINCIPAL_INVESTIGATOR
References: