Lung Cancer
Conditions
Keywords
stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, recurrent non-small cell lung cancer
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.
Interventions
OTHEReducational intervention
Undergo individualized interdisciplinary palliative care intervention
OTHERmedical chart review
Ancillary studies
OTHERquestionnaire administration
Ancillary studies
PROCEDUREend-of-life treatment/management
Undergo end-of-life treatment/management
PROCEDUREpsychosocial assessment and care
Undergo psychosocial assessment and care
PROCEDUREquality-of-life assessment
Ancillary studies
PROCEDUREmanagement of therapy complications
Undergo management of therapy complications
PROCEDUREassessment of therapy complications
Undergo assessment of therapy complications
Sponsors
National Cancer Institute (NCI)
City of Hope Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | 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 |
Countries
United States
Outcome results
None listed