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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

Primary Purpose

Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
educational intervention
medical chart review
questionnaire administration
end-of-life treatment/management
psychosocial assessment and care
quality-of-life assessment
management of therapy complications
assessment of therapy complications
Sponsored by
City of Hope Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Lung Cancer focused on measuring stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, recurrent non-small cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • City of Hope Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Phase 2 Intervention

Phase I Usual Care

Arm 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.

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

Outcomes

Primary Outcome Measures

Overall quality of life and psychological distress
Symptom control
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
Resource use as measured by chart audits
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

Secondary Outcome Measures

Full Information

First Posted
January 15, 2009
Last Updated
November 4, 2015
Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00823732
Brief Title
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
Official Title
Palliative Care for Quality of Life and Symptom Concerns in Late Stage Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, recurrent non-small cell lung cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
280 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phase 2 Intervention
Arm Type
Active Comparator
Arm 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.
Arm Title
Phase I Usual Care
Arm Type
No Intervention
Arm Description
GROUP I (usual care): Patients receive standard care.
Intervention Type
Other
Intervention Name(s)
educational intervention
Intervention Description
Undergo individualized interdisciplinary palliative care intervention
Intervention Type
Other
Intervention Name(s)
medical chart review
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
questionnaire administration
Intervention Description
Ancillary studies
Intervention Type
Procedure
Intervention Name(s)
end-of-life treatment/management
Intervention Description
Undergo end-of-life treatment/management
Intervention Type
Procedure
Intervention Name(s)
psychosocial assessment and care
Intervention Description
Undergo psychosocial assessment and care
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment
Intervention Description
Ancillary studies
Intervention Type
Procedure
Intervention Name(s)
management of therapy complications
Other Intervention Name(s)
complications of therapy, management of
Intervention Description
Undergo management of therapy complications
Intervention Type
Procedure
Intervention Name(s)
assessment of therapy complications
Intervention Description
Undergo assessment of therapy complications
Primary Outcome Measure Information:
Title
Overall quality of life and psychological distress
Time Frame
6 months after study enrollment
Title
Symptom control
Time Frame
6 months after study enrollment
Title
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
Title
Resource use as measured by chart audits
Time Frame
6 months after study enrollment
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Betty Ferrell, PhD
Organizational Affiliation
City of Hope Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope Comprehensive Cancer Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010-3000
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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