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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

361 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2019-04-22

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Phase I (usual care)

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.

Group Type ACTIVE_COMPARATOR

quality-of-life assessment

Intervention Type OTHER

Ancillary studies

questionnaire administration

Intervention Type OTHER

Ancillary studies

Phase II (individualized palliative care)

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.

Group Type EXPERIMENTAL

Palliative Therapy

Intervention Type OTHER

Receive individualized palliative care

quality-of-life assessment

Intervention Type OTHER

Ancillary studies

questionnaire administration

Intervention Type OTHER

Ancillary studies

Interventions

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Palliative Therapy

Receive individualized palliative care

Intervention Type OTHER

quality-of-life assessment

Ancillary studies

Intervention Type OTHER

questionnaire administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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Comfort Care Palliative Care Palliative Treatment Symptom Management quality of life assessment

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No