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

Lung Cancer Clinical Trial

Official title:

Palliative Care for Quality of Life and Symptom Concerns in Late Stage Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00823732
• Other study ID #: 08035
• Secondary ID: P01CA136396P30CA
• Status: Completed
• Phase: N/A
• First received: January 15, 2009
• Last updated: November 4, 2015
• Start date: October 2008
• Est. completion date: October 2014

Study information

• Verified date: November 2015
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Other:
• educational intervention
Undergo individualized interdisciplinary palliative care intervention
• medical chart review
Ancillary studies
• questionnaire administration
Ancillary studies

Procedure:
• end-of-life treatment/management
Undergo end-of-life treatment/management
• psychosocial assessment and care
Undergo psychosocial assessment and care
• quality-of-life assessment
Ancillary studies
• management of therapy complications
Undergo management of therapy complications
• assessment of therapy complications
Undergo assessment of therapy complications

Locations

Country	Name	City	State
United States	City of Hope Comprehensive Cancer Center	Duarte	California

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall quality of life and psychological distress		6 months after study enrollment	No
Primary	Symptom control		6 months after study enrollment	No
Primary	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		6 months after study enrollment	No
Primary	Resource use as measured by chart audits		6 months after study enrollment	No
Primary	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		Week 24 after study enrollment	No