Basic Trial Information
Trial Description
Summary
Further Trial Information
Eligibility Criteria
Trial Contact Information
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| No phase specified | Educational/Counseling/Training, Natural history/Epidemiology, Supportive care | Enrolling by invitation | 18 and over | NCI, Other | 08035 P01CA136396, P30CA033572, CHNMC-08035, CDR0000631258, NCT00823732 |
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.
Further Study Information
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.
Eligibility Criteria
Criteria:
- Diagnosis of stage IIIb-IV unresectable NSCLC
- Undergoing treatment with chemotherapy, radiation, or combined modalities
- Living within a 50 mile radius of the City of Hope
- No previous cancer within the past 5 years
Trial Lead Organizations/Sponsors
City of Hope Comprehensive Cancer Center
National Cancer Institute| Betty Ferrell | ![]() | Principal Investigator |
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00823732
Information obtained from ClinicalTrials.gov on January 07, 2013
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