Palliative Care Interventions for Outpatients Newly Diagnosed With Lung Cancer: Phase II (PCI2)

VA Office of Research and Development

Status: Completed

Conditions: Lung Cancer

Treatments: Behavioral: Palliative Care

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT03007953

NRI 15-456

Details and patient eligibility

About

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.

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.

Enrollment: 151 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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151 participants in 2 patient groups

Intervention

Experimental group

Description:

This is a nurse-led telephone-based program integrating palliative care into usual oncologic care for patients diagnosed within 2 months of any type and stage of lung cancer, who will receive therapy other than solely surgical resection. The intervention lasts for the duration of patients' primary lung cancer treatment (usually 3-4 months).

Treatment:

Behavioral: Palliative Care

Usual Care

No Intervention group

Description:

Subjects randomized to the usual care arm will receive medical oncology, radiation oncology, pulmonary, CT surgery, as indicated by the type and stage of cancer. At the completion of their primary lung cancer treatment, they will be disenrolled from the study.