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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT00823732
First received: January 15, 2009
Last updated: January 6, 2014
Last verified: January 2014
  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:


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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Principal Investigator: Betty Ferrell, PhD Beckman Research Institute
  More Information

Additional Information:
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 6, 2014
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 August 01, 2014