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


N/A
18 Years
N/A
Open (Enrolling by invite only)
Both
Lung Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall quality of life and psychological distress

Outcome Time Frame:

6 months after study enrollment

Safety Issue:

No

Principal Investigator

Betty Ferrell, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beckman Research Institute

Authority:

United States: Institutional Review Board

Study ID:

08035

NCT ID:

NCT00823732

Start Date:

October 2008

Completion Date:

Related Keywords:

  • Lung Cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • recurrent non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

City of Hope Comprehensive Cancer CenterDuarte, California  91010