Palliative Care Intervention in Improving Symptom Control and Quality of Life in Patients With Stage II-IV Non-small Cell Lung Cancer and Their Family Caregivers

PRIMARY OBJECTIVES:

I. Adapt a Palliative Care Intervention (PCI) tested in a National Cancer Institute (NCI)
funded Program Project (P01) for dissemination to other oncology settings.

II. Determine the impact of the PCI on patient outcomes including symptom control, quality of
life (QOL), and distress as compared to the usual care group.

III. Determine the impact of the PCI on family caregivers (FCG) outcomes including caregiver
burden, caregiver distress, skills preparation and QOL as compared to the usual care group.

IV. Test the effects of the PCI on patient resource utilization as compared to the usual care
group.

OUTLINE: Participants are enrolled sequentially to 1 of 2 phases.

PHASE I: Participants receive usual care. This phase will aid in identifying usual care
patterns in each site and provide an audit of system utilization as well as finalization of
the educational materials for Phase II.

PHASE II: Participants receive individualized palliative care comprised of tailored
educational sessions designed for each patient and FCG that have been modified based on
patterns observed in Phase I. The first patient teaching session will cover physical and
psychological areas and the second will cover social and spiritual areas. These sessions will
be completed within 2 weeks of accrual. A third teaching session is held with the FCG alone
to give the FCG the opportunity to discuss their perspectives and focus on their needs.
Patients will be asked to identify topics they want included and which if any should be
omitted which provides for tailoring of the content to the patient's needs and preferences.

In both groups, participants are followed up for 3 months.

Inclusion Criteria:

Patient eligibility criteria for entry into the project include:

- Diagnosis of stages II-IV non-small cell lung cancer (NSCLC)

- Undergoing treatment with surgery, chemotherapy, radiation, or combined modalities

- In Phase 2, subjects are also required on accrual to be referred to Palliative Care

FCG eligibility criteria include:

- Designated by the patient as a person closely involved in their care

- Age 18 years and older

All subjects must have the ability to understand and the willingness to sign a written
informed consent