Clinical trial · Observational
Caregiver Burden, Quality of Life, and Symptom Distress at Different Palliative Cancer Care Settings
NCT04186884CI-TRIAL-00056858completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Malignant Neoplasm | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Locally Advanced Malignant Neoplasm | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Metastatic Malignant Neoplasm | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Recurrent Malignant Neoplasm | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Observational (questionnaires)
- description
- Patients and caregivers visiting SCC for a consult or admitted to PCU complete questionnaires over 35 minutes.
- interventionNames
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
Primary outcomes (1)
- 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
- description
- 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 (5)
- measure
- Objective burden (impact on tangible aspects of life Questionnaire
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.