Palliative Care Interventions for Outpatients Newly Diagnosed With Lung Cancer: Phase II (PCI2)

July 19, 2023 updated by: VA Office of Research and Development
The focus of the study is to test a nurse-led telephone-based palliative care intervention on improving the delivery of care for patients with newly diagnosed lung cancer. The study is a three site randomized control trial to determine the efficacy of the intervention on improving patients' quality of life, symptom burden, and satisfaction of care. Additionally, the study will test an innovative care delivery model to improve patients' access to palliative care. The investigators will also determine the effect of the intervention on patient activation to discuss treatment preferences with their clinician and on clinician knowledge of patients' goals of care.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients meeting entry criteria will be randomized to the intervention arm, palliative care plus usual care, or the usual care arm. Patients randomized to the intervention arm will receive usual oncologic care and phone calls from a nurse. Outcome measures will be collected at baseline and at the end of the patients' primary cancer treatment. The study will be performed at the Puget Sound Health Care System, Birmingham VA and Portland VA. The investigators will recruit individuals (n=138) with lung cancer over 2.5 years. The primary objective is to determine the efficacy of the nurse-led telephone-based palliative intervention on improving patients' quality of life, symptom burden, and satisfaction of care. In addition, using validated instruments, the investigators will assess the effect of the intervention on patient activation to discuss treatment preferences with their clinician and on clinician knowledge of patients' goals of care. The results of this study will inform a future effectiveness/implementation study.

Study Type

Interventional

Enrollment (Actual)

151

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233-1927
        • Birmingham VA Medical Center, Birmingham, AL
    • Oregon
      • Portland, Oregon, United States, 97239
        • VA Portland Health Care System, Portland, OR
    • Washington
      • Seattle, Washington, United States, 98108-1532
        • VA Puget Sound Health Care System Seattle Division, Seattle, WA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Patients diagnosed at the Puget Sound Health Care System, Birmingham VA, or Portland VA with a primary diagnosis of lung cancer that requires more than surgical resection:

  • diagnosed within 8 weeks of recruitment
  • must have telephone access
  • ability to understand English
  • able to participate in informed consent process

Exclusion Criteria:

Patients not eligible to participate in the study include those who are inpatients prior to randomization,

  • those who are under the care of palliative care or hospice at the time of randomization
  • those who have severe mental health disorders
  • those who are unable to speak directly with the nurse over the telephone
  • or those that have the inability to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
This is a nurse-led telephone-based program integrating palliative care into usual oncologic care for patients diagnosed within 2 months of any type and stage of lung cancer, who will receive therapy other than solely surgical resection. The intervention lasts for the duration of patients' primary lung cancer treatment (usually 3-4 months).
Behavioral: Palliative Care
Care delivered by a nurse, including symptom assessment and management, patient education on lung cancer and treatment options, discussion and communication about preferences for care, psychosocial assessment (including referrals to ancillary services), and patient-centered resources. A personalized treatment plan based on the patient's lung cancer stage, treatment, symptoms and psychosocial needs will be developed by the palliative care team (physician, study nurse) with input from the patient and family member. The study nurse will assess patient's symptoms, implement and monitor the treatment plan applying established End-of- Life Nursing Education Consortium (ELNEC) for Veterans protocols.
Other Names:
  • Supportive Care
No Intervention: Usual Care
Subjects randomized to the usual care arm will receive medical oncology, radiation oncology, pulmonary, CT surgery, as indicated by the type and stage of cancer. At the completion of their primary lung cancer treatment, they will be disenrolled from the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Functional Assessment of Cancer Therapy-Lung Total Outcome Index Score at Final Visit
Time Frame: Baseline and 3 Months
Patient Quality of Life including symptoms as measured by the FACT-L (Functional Assessment of Cancer Therapy-Lung Scale). The FACT-L outcome measure reported is the mean change in the TOI subscale (Total Outcome Index) of the instrument, computed as the differences between final and baseline visit scores. The TOI subscale range is 0-84, with a higher score indicating a better quality of life. Among patients with newly diagnosed lung cancer, provision of a telephone-based palliative care intervention will be associated with a change in FACT-L TOI score. The investigators will assess the difference in FACT-L TOI scores between the intervention and control subjects.
Baseline and 3 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Patient Satisfaction of Care at Final Visit
Time Frame: Baseline and 3 Months
Patient satisfaction with care will be assessed by using the FAMCARE-Patient Survey 13 (full unabbreviated scale name). The FAMCARE is a 13 item, 5 point likert-scale validated questionnaire measuring patient satisfaction with cancer care and assessing interactions with health care providers, performance status and symptom burden. Only total score are reported (no subscales). Scores range from 13-65 with scores of 52 > being satisfied with care. In full randomized clinical trials the estimated MID is 5 points from baseline to 12 weeks. Among patients with newly diagnosed lung cancer, provision of a telephone-based palliative care intervention will be associated with a change in FAMCARE-P13 score. The investigators will assess the difference in FAMCARE-P13 scores between the intervention and control subjects.
Baseline and 3 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: Lynn F. Reinke, PhD ARNP, VA Puget Sound Health Care System Seattle Division, Seattle, WA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 5, 2016

Primary Completion (Actual)

December 11, 2019

Study Completion (Actual)

December 11, 2019

Study Registration Dates

First Submitted

December 19, 2016

First Submitted That Met QC Criteria

December 28, 2016

First Posted (Estimated)

January 2, 2017

Study Record Updates

Last Update Posted (Actual)

July 27, 2023

Last Update Submitted That Met QC Criteria

July 19, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NRI 15-456

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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