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 Text View

Purpose

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.

Condition	Intervention
Lung Cancer	Other: educational intervention Other: medical chart review Other: questionnaire administration Procedure: end-of-life treatment/management Procedure: psychosocial assessment and care Procedure: quality-of-life assessment Procedure: management of therapy complications Procedure: assessment of therapy complications

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care
Official Title:	Palliative Care for Quality of Life and Symptom Concerns in Late Stage Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Cancer Lung Cancer Palliative Care

U.S. FDA Resources

Further study details as provided by City of Hope Medical Center:

Primary Outcome Measures:

Overall quality of life and psychological distress [ Time Frame: 6 months after study enrollment ] [ Designated as safety issue: No ]
Symptom control [ Time Frame: 6 months after study enrollment ] [ Designated as safety issue: No ]
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 [ Time Frame: 6 months after study enrollment ] [ Designated as safety issue: No ]
Resource use as measured by chart audits [ Time Frame: 6 months after study enrollment ] [ Designated as safety issue: No ]
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 [ Time Frame: Week 24 after study enrollment ] [ Designated as safety issue: No ]

Estimated Enrollment:	326
Study Start Date:	October 2008
Estimated Primary Completion Date:	January 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 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.	Other: educational intervention Undergo individualized interdisciplinary palliative care intervention Other: medical chart review Ancillary studies Other: questionnaire administration Ancillary studies Procedure: end-of-life treatment/management Undergo end-of-life treatment/management Procedure: psychosocial assessment and care Undergo psychosocial assessment and care Procedure: quality-of-life assessment Ancillary studies Procedure: management of therapy complications Undergo management of therapy complications Other Name: complications of therapy, management of Procedure: assessment of therapy complications Undergo assessment of therapy complications
No Intervention: Phase I Usual Care GROUP I (usual care): Patients receive standard care.

Arms

Assigned Interventions

Active Comparator: 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.

Other: educational intervention

Undergo individualized interdisciplinary palliative care intervention

Other: medical chart review

Ancillary studies

Other: questionnaire administration

Ancillary studies

Procedure: end-of-life treatment/management

Undergo end-of-life treatment/management

Procedure: psychosocial assessment and care

Undergo psychosocial assessment and care

Procedure: quality-of-life assessment

Ancillary studies

Procedure: management of therapy complications

Undergo management of therapy complications

Other Name: complications of therapy, management of

Procedure: assessment of therapy complications

Undergo assessment of therapy complications

No Intervention: Phase I Usual Care

GROUP I (usual care): Patients receive standard care.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00823732

Locations

United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000

Sponsors and Collaborators

City of Hope Medical Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Betty Ferrell, PhD

Beckman Research Institute

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	City of Hope Medical Center
ClinicalTrials.gov Identifier:	NCT00823732 History of Changes
Other Study ID Numbers:	08035, P01CA136396, P30CA033572, CHNMC-08035, CDR0000631258
Study First Received:	January 15, 2009
Last Updated:	January 4, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by City of Hope Medical Center:

stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
recurrent non-small cell lung cancer

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms

Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013