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Clinical Trials/NCT00823732
NCT00823732
Completed
N/A

Palliative Care for Quality of Life and Symptom Concerns in Late Stage Lung Cancer

City of Hope Medical Center1 site in 1 country280 target enrollmentOctober 2008
ConditionsLung Cancer

Overview

Phase
N/A
Intervention
Not specified
Conditions
Lung Cancer
Sponsor
City of Hope Medical Center
Enrollment
280
Locations
1
Primary Endpoint
Overall quality of life and psychological distress
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

RATIONALE: Palliative care may be more effective than standard care in improving quality of life and symptoms in patients with lung cancer.

PURPOSE: This clinical trial is studying the effects of palliative care on quality of life and symptom control in patients with stage IIIB or stage IV non-small cell lung cancer that cannot be removed by surgery.

Detailed Description

OBJECTIVES: * To compare the effects of palliative care intervention (PCI) vs standard care on overall quality of life and psychological distress in patients with unresectable stage IIIB or IV non-small cell lung cancer. * To compare symptom control in these patients. * To compare geriatric assessment outcomes, as measured by OARS Instrumental Activities of Daily Living, MOS Activities of Daily Living, MOS Social Activities Limitation Scale, Hospital Anxiety and Depression Scale scores, and Karnofsky performance scale, in these patients. * To compare the effects of the PCI vs standard care on resource use. * To identify subgroups of patients who benefit most from the PCI in relation to sociodemographic characteristics, treatment factors, and geriatric assessment predictors at week 12. OUTLINE: Patients are assigned to 1 of 2 groups. Group I (usual care): Patients receive standard care. Group II (palliative care intervention): Patients receive an individualized interdisciplinary palliative care intervention comprising sessions, focused on physical, psychological, social, and spiritual well-being, once weekly in weeks 3-6. Patients then receive 4 follow-up phone calls in weeks 9, 13, 17, and 21.

Registry
clinicaltrials.gov
Start Date
October 2008
End Date
October 2014
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
City of Hope Medical Center
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Overall quality of life and psychological distress

Time Frame: 6 months after study enrollment

Symptom control

Time Frame: 6 months after study enrollment

Geriatric assessment outcomes as measured by OARS Instrumental Activities of Daily Living, MOS Activities of Daily Living, MOS Social Activities Limitation Scale, Hospital Anxiety and Depression Scale scores, and Karnofsky performance scale

Time Frame: 6 months after study enrollment

Resource use as measured by chart audits

Time Frame: 6 months after study enrollment

Identification of subgroups of patients who benefit most from the palliative care intervention in relation to sociodemographic characteristics, treatment factors, and geriatric assessment predictors at week 24

Time Frame: Week 24 after study enrollment

Study Sites (1)

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