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
NCT ID: NCT00823732
Last Updated: 2015-11-06
Study Results
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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COMPLETED
NA
280 participants
INTERVENTIONAL
2008-10-31
2014-10-31
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Phase 2 Intervention
GROUP II (palliative care intervention): Patients receive an individualized interdisciplinary palliative care intervention comprising learner-centered, knowledge-centered, assessment-centered, and community-centered concepts. Patients undergo 4 teaching 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.
educational intervention
Undergo individualized interdisciplinary palliative care intervention
medical chart review
Ancillary studies
questionnaire administration
Ancillary studies
end-of-life treatment/management
Undergo end-of-life treatment/management
psychosocial assessment and care
Undergo psychosocial assessment and care
quality-of-life assessment
Ancillary studies
management of therapy complications
Undergo management of therapy complications
assessment of therapy complications
Undergo assessment of therapy complications
Phase I Usual Care
GROUP I (usual care): Patients receive standard care.
No interventions assigned to this group
Interventions
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educational intervention
Undergo individualized interdisciplinary palliative care intervention
medical chart review
Ancillary studies
questionnaire administration
Ancillary studies
end-of-life treatment/management
Undergo end-of-life treatment/management
psychosocial assessment and care
Undergo psychosocial assessment and care
quality-of-life assessment
Ancillary studies
management of therapy complications
Undergo management of therapy complications
assessment of therapy complications
Undergo assessment of therapy complications
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
City of Hope Medical Center
OTHER
Responsible Party
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Principal Investigators
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Betty Ferrell, PhD
Role: PRINCIPAL_INVESTIGATOR
City of Hope Comprehensive Cancer Center
Locations
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City of Hope Comprehensive Cancer Center
Duarte, California, United States
Countries
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Other Identifiers
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CHNMC-08035
Identifier Type: -
Identifier Source: secondary_id
CDR0000631258
Identifier Type: REGISTRY
Identifier Source: secondary_id
08035
Identifier Type: -
Identifier Source: org_study_id
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