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

NCT ID: NCT04186884

Last Updated: 2022-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

351 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-26

Study Completion Date

2021-11-05

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Advanced Malignant Neoplasm Locally Advanced Malignant Neoplasm Metastatic Malignant Neoplasm Recurrent Malignant Neoplasm

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Observational (questionnaires)

Patients and caregivers visiting SCC for a consult or admitted to PCU complete questionnaires over 35 minutes.

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Questionnaire Administration

Intervention Type OTHER

Complete questionnaires

Interventions

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Quality-of-Life Assessment

Ancillary studies

Intervention Type OTHER

Questionnaire Administration

Complete questionnaires

Intervention Type OTHER

Other Intervention Names

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Quality of Life Assessment

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kimberson C Tanco

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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M D Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

Related Links

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http://www.mdanderson.org

University of Texas MD Anderson Cancer Center Website

Other Identifiers

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NCI-2019-01197

Identifier Type: REGISTRY

Identifier Source: secondary_id

2018-0819

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA016672

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2018-0819

Identifier Type: -

Identifier Source: org_study_id

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