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

City of Hope

Status: Completed

Conditions: Stage IIB Non-small Cell Lung Cancer; Stage IIIB Non-small Cell Lung Cancer; Stage IV Non-small Cell Lung Cancer; Stage IIA Non-small Cell Lung Cancer; Psychological Impact of Cancer and Its Treatment; Caregiver; Stage IIIA Non-small Cell Lung Cancer; Recurrent Non-small Cell Lung Cancer

Treatments: Other: questionnaire administration; Other: quality-of-life assessment; Other: Palliative Therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02243748

1R01NR015341-01 (U.S. NIH Grant/Contract)

14206 (Other Identifier)

NCI-2014-01926 (Registry Identifier)

Details and patient eligibility

About

This clinical trial studies a 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. Palliative care programs can provide patients and their caregivers with information on how to manage their symptoms, maintain health and well-being, and access supportive care services. An interdisciplinary palliative care model may effectively link lung cancer patients to the appropriate supportive care services in a timely fashion.

Full description

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.

Enrollment: 361 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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361 participants in 2 patient groups

Phase I (usual care)

Active Comparator group

Description:

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.

Treatment:

Other: questionnaire administration

Other: quality-of-life assessment

Phase II (individualized palliative care)

Experimental group

Description:

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.

Treatment:

Other: questionnaire administration

Other: Palliative Therapy

Other: quality-of-life assessment