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NCT Number: NCT02243748

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

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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Key information

Conditions

Caregiver Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Psychological Impact of Cancer and Its Treatment Recurrent Non-small Cell Lung Cancer Respiratory Tract Diseases Respiratory Tract Neoplasms 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 Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

City of Hope Medical Center, Duarte, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Palliative Therapy

Other

Receive individualized palliative care

Other names: Comfort Care, Palliative Care, Palliative Treatment, Symptom Management

Quality-of-Life Assessment

Other

Ancillary studies

Other names: quality of life assessment

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. Impact of the PCI on symptom control as compared to the usual care group

    Time frame: Up to 3 months

    The demographic and clinical characteristics as well as baseline symptom control scores in the two phases will be compared. A repeated measures mixed model will be utilized for the three repeated measures (0, 1, and 3 months).

  2. Impact of the PCI on patient QOL as compared to the usual care group

    Time frame: Up to 3 months

    The demographic and clinical characteristics as well as baseline QOL scores in the two phases will be compared. A repeated measures mixed model will be utilized for the three repeated measures (0, 1, and 3 months).

  3. Impact of the PCI on psychological distress as compared to the usual care group

    Time frame: Up to 3 months

    The demographic and clinical characteristics as well as baseline psychological distress scores in the two phases will be compared. A repeated measures mixed model will be utilized for the three repeated measures (0, 1, and 3 months).

  4. Impact of the PCI on caregiver burden as compared to the usual care group

    Time frame: Up to 3 months

    The demographic and clinical characteristics as well as baseline caregiver burden scores in the two phases will be compared. A repeated measures mixed model will be utilized for the three repeated measures (0, 1, and 3 months).

  5. Impact of the PCI on caregiver distress as compared to the usual care group

    Time frame: Up to 3 months

    The demographic and clinical characteristics as well as baseline caregiver distress scores in the two phases will be compared. A repeated measures mixed model will be utilized for the three repeated measures (0, 1, and 3 months).

  6. Impact of the PCI on caregiver skills preparation as compared to the usual care group

    Time frame: Up to 3 months

    The demographic and clinical characteristics as well as baseline caregiver skills preparation scores in the two phases will be compared. A repeated measures mixed model will be utilized for the three repeated measures (0, 1, and 3 months).

  7. Impact of the PCI on caregiver QOL as compared to the usual care group

    Time frame: Up to 3 months

    The demographic and clinical characteristics as well as baseline caregiver QOL scores in the two phases will be compared. A repeated measures mixed model will be utilized for the three repeated measures (0, 1, and 3 months).

  8. Effects of the PCI on resource utilization as compared to the usual care group

    Time frame: Up to 3 months

Sponsors and collaborators

Lead sponsor

City of Hope Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)
  • National Institute of Nursing Research (NINR)

Registry information

Official study title

Translation of a Lung Cancer Palliative Care Intervention for Clinical Practice

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Sep 18, 2014
Registry last updated
May 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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