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

City of Hope

Status

Completed

Conditions

Lung Cancer

Treatments

Procedure: management of therapy complications

Procedure: end-of-life treatment/management

Procedure: quality-of-life assessment

Other: educational intervention

Other: questionnaire administration

Procedure: assessment of therapy complications

Other: medical chart review

Procedure: psychosocial assessment and care

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00823732

CHNMC-08035

CDR0000631258 (Registry Identifier)

P30CA033572 (U.S. NIH Grant/Contract)

08035

P01CA136396 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

280 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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 design

Primary purpose

Supportive Care

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

280 participants in 2 patient groups

Phase 2 Intervention

Active Comparator group

Description:

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.

Treatment: