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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

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ClinicalTrials.gov Identifier: NCT02243748
Recruitment Status : Recruiting
First Posted : September 18, 2014
Last Update Posted : October 18, 2017
Sponsor:
Collaborators:
National Cancer Institute (NCI)
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
City of Hope Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
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 Other: Palliative Therapy Other: quality-of-life assessment Other: questionnaire administration Not Applicable

Detailed 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 385 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Translation of a Lung Cancer Palliative Care Intervention for Clinical Practice
Study Start Date : February 2015
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
Other: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment

Other: questionnaire administration
Ancillary studies

Experimental: 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.
Other: Palliative Therapy
Receive individualized palliative care
Other Names:
  • Comfort Care
  • Palliative Care
  • Palliative Treatment
  • Symptom Management

Other: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment

Other: questionnaire administration
Ancillary studies




Primary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02243748


Locations
United States, California
City of Hope Medical Center Active, not recruiting
Duarte, California, United States, 91010
Southern California Permanente Medical Group Recruiting
Irvine, California, United States, 92618
Contact: Tieu O. Phung    800-777-1370      
Principal Investigator: Tieu O. Phung         
Kaiser Permanente-Ontario Vineyard Medical Offices and Ambulatory SurgiCenter Recruiting
Ontario, California, United States, 91761
Contact: Thomas Cuyegkang    888-750-0036      
Principal Investigator: Thomas Cuyegkang         
Kaiser Permanente Department of Research and Evaluation Active, not recruiting
Pasadena, California, United States, 91101
Kaiser Permanente Medical Center Recruiting
Riverside, California, United States, 92505
Contact: Karisa Jahn    951-353-2000      
Principal Investigator: Karisa Jahn         
Sponsors and Collaborators
City of Hope Medical Center
National Cancer Institute (NCI)
National Institute of Nursing Research (NINR)
Investigators
Principal Investigator: Betty Ferrell City of Hope Medical Center
Principal Investigator: Huong Nguyen, MD Kaiser Permanente Department of Research and Evaluation

Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT02243748     History of Changes
Other Study ID Numbers: 14206
NCI-2014-01926 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
14206 ( Other Identifier: City of Hope Medical Center )
1R01NR015341-01 ( U.S. NIH Grant/Contract )
First Posted: September 18, 2014    Key Record Dates
Last Update Posted: October 18, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms