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

Completed

• Conditions: Recurrent Malignant Neoplasm; Metastatic Malignant Neoplasm; Advanced Malignant Neoplasm; Locally Advanced Malignant Neoplasm
• Interventions: Other: Quality-of-Life Assessment; Other: Questionnaire Administration

• Registration Number: NCT04186884
• Lead Sponsor: M.D. Anderson Cancer Center

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.

Study Timeline

• Study Start: 2019-03-26
• Study First Submitted: 2019-03-28
• Study First Submitted QC: 2019-12-02
• Study First Posted: 2019-12-05
• Primary Completion: 2021-11-05
• Study Completion: 2021-11-05
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-02
• Last Update Posted: 2022-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 351

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational (questionnaires)	Quality-of-Life Assessment	Patients and caregivers visiting SCC for a consult or admitted to PCU complete questionnaires over 35 minutes.
Observational (questionnaires)	Questionnaire Administration	Patients and caregivers visiting SCC for a consult or admitted to PCU complete questionnaires over 35 minutes.

Primary Outcome Measures

Name	Time	Method
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)	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 Outcome Measures

Name	Time	Method
Caregiver symptom distress	Day 1, day of enrollment	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
Subjective demand burden (impact on the patient-caregiver relationship) of caregivers	Day 1, day of enrollment	Measured by Montgomery-Borgatta Caregiver Burden Scale using the 4-item subjective demand burden sub-scale questionnaire. (ranges from 0.81 to 0.88)
Caregiver quality of life and symptoms of distress	Day 1, day of enrollment	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)
Objective burden (impact on tangible aspects of life Questionnaire	Day 1, day of enrollment	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
Factors that are associated with caregiver burden, quality of life, and symptom distress Questionnaires	Day 1, day of enrollment	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

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States