Lung Cancer Clinical Trial

Palliative Care Interventions for Outpatients Newly Diagnosed With Lung Cancer: Phase II

Summary

The focus of the study is to test a nurse-led telephone-based palliative care intervention on improving the delivery of care for patients with newly diagnosed lung cancer. The study is a three site randomized control trial to determine the efficacy of the intervention on improving patients' quality of life, symptom burden, and satisfaction of care. Additionally, the study will test an innovative care delivery model to improve patients' access to palliative care. The investigators will also determine the effect of the intervention on patient activation to discuss treatment preferences with their clinician and on clinician knowledge of patients' goals of care.

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Full Description

Patients meeting entry criteria will be randomized to the intervention arm, palliative care plus usual care, or the usual care arm. Patients randomized to the intervention arm will receive usual oncologic care and phone calls from a nurse. Outcome measures will be collected at baseline and at the end of the patients' primary cancer treatment. The study will be performed at the Puget Sound Health Care System, Birmingham VA and Portland VA. The investigators will recruit individuals (n=138) with lung cancer over 2.5 years. The primary objective is to determine the efficacy of the nurse-led telephone-based palliative intervention on improving patients' quality of life, symptom burden, and satisfaction of care. In addition, using validated instruments, the investigators will assess the effect of the intervention on patient activation to discuss treatment preferences with their clinician and on clinician knowledge of patients' goals of care. The results of this study will inform a future effectiveness/implementation study.

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Eligibility Criteria

Inclusion Criteria:

Patients diagnosed at the Puget Sound Health Care System, Birmingham VA, or Portland VA with a primary diagnosis of lung cancer that requires more than surgical resection:

diagnosed within 8 weeks of recruitment
must have telephone access
ability to understand English
able to participate in informed consent process

Exclusion Criteria:

Patients not eligible to participate in the study include those who are inpatients prior to randomization,

those who are under the care of palliative care or hospice at the time of randomization
those who have severe mental health disorders
those who are unable to speak directly with the nurse over the telephone
or those that have the inability to provide informed consent

Study is for people with:

Lung Cancer

Estimated Enrollment:

151

Study ID:

NCT03007953

Recruitment Status:

Completed

Sponsor:

VA Office of Research and Development

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There are 3 Locations for this study

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Birmingham VA Medical Center, Birmingham, AL
Birmingham Alabama, 35233, United States
VA Portland Health Care System, Portland, OR
Portland Oregon, 97239, United States
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle Washington, 98108, United States

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Study is for people with:

Lung Cancer

Estimated Enrollment:

151

Study ID:

NCT03007953

Recruitment Status:

Completed

Sponsor:


VA Office of Research and Development

How clear is this clinincal trial information?

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