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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 has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT00823732
First received: January 15, 2009
Last updated: October 1, 2014
Last verified: October 2014

January 15, 2009
October 1, 2014
October 2008
October 2014   (final data collection date for primary outcome measure)
  • 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 ]
  • Overall quality of life and psychological distress [ Designated as safety issue: No ]
  • Symptom control [ 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 [ Designated as safety issue: No ]
  • Resource use as measured by chart audits [ 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 12 [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00823732 on ClinicalTrials.gov Archive Site
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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
Palliative Care for Quality of Life and Symptom Concerns in Late Stage Lung Cancer

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:

  • 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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Lung Cancer
  • 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
  • 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.
    Interventions:
    • 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
  • No Intervention: Phase I Usual Care
    GROUP I (usual care): Patients receive standard care.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
280
Not Provided
October 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00823732
08035, P01CA136396, P30CA033572, CHNMC-08035, CDR0000631258
Yes
City of Hope Medical Center
City of Hope Medical Center
National Cancer Institute (NCI)
Principal Investigator: Betty Ferrell, PhD Beckman Research Institute
City of Hope Medical Center
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP