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| ID | Type | Description | Link |
|---|---|---|---|
| P01CA136396 | U.S. NIH Grant/Contract | View source | |
| P30CA033572 | U.S. NIH Grant/Contract | View source | |
| CHNMC-08035 | |||
| CDR0000631258 | Registry Identifier | NCI PDQ |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 2 Intervention | Active Comparator | 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. |
|
| Phase I Usual Care | No Intervention | GROUP I (usual care): Patients receive standard care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| educational intervention | Other | Undergo individualized interdisciplinary palliative care intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall quality of life and psychological distress | 6 months after study enrollment | |
| Symptom control | 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 | 6 months after study enrollment | |
| Resource use as measured by chart audits | 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 | Week 24 after study enrollment |
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Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Betty Ferrell, PhD | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Comprehensive Cancer Center | Duarte | California | 91010-3000 | United States |
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| medical chart review | Other | Ancillary studies |
|
| questionnaire administration | Other | Ancillary studies |
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| end-of-life treatment/management | Procedure | Undergo end-of-life treatment/management |
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| psychosocial assessment and care | Procedure | Undergo psychosocial assessment and care |
|
| quality-of-life assessment | Procedure | Ancillary studies |
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| management of therapy complications | Procedure | Undergo management of therapy complications |
|
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| assessment of therapy complications | Procedure | Undergo assessment of therapy complications |
|
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
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| ID | Term |
|---|---|
| D018479 | Early Intervention, Educational |
| D013812 | Therapeutics |
| D000067250 | Psychiatric Rehabilitation |
| ID | Term |
|---|---|
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D011314 | Preventive Health Services |
| D012046 | Rehabilitation |
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