Clinical trial NCT03007953: Palliative Care Interventions for Outpatients Newly Diagnosed With Lung Cancer: Phase II
Official title: Palliative Care Interventions for Outpatients Newly Diagnosed With Lung Cancer: Phase II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Keywords: Palliative Care
Supportive Care
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2017-01-02
Enrollment: 151
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Functional Assessment of Cancer Therapy-Lung Total Outcome Index Score at Final Visit
timeFrame: Baseline and 3 Months
Secondary outcomes:
measure: Change From Baseline in Patient Satisfaction of Care at Final Visit
timeFrame: Baseline and 3 Months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham VA Medical Center, Birmingham, AL
state: Alabama
city: Portland
country: United States
facility: VA Portland Health Care System, Portland, OR
state: Oregon
city: Seattle
country: United States
facility: VA Puget Sound Health Care System Seattle Division, Seattle, WA
state: Washington
Study officials:
affiliation: VA Puget Sound Health Care System Seattle Division, Seattle, WA
name: Lynn F. Reinke, PhD ARNP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Reinke LF, Meier DE. Research Priorities in Subspecialty Palliative Care: Policy Initiatives. J Palliat Med. 2017 Aug;20(8):813-820. doi: 10.1089/jpm.2017.0303.
citation: Aslakson RA, Reinke LF, Cox C, Kross EK, Benzo RP, Curtis JR. Developing a Research Agenda for Integrating Palliative Care into Critical Care and Pulmonary Practice To Improve Patient and Family Outcomes. J Palliat Med. 2017 Apr;20(4):329-343. doi: 10.1089/jpm.2016.0567.
citation: Reinke LF, Vig EK, Tartaglione EV, Backhus LM, Gunnink E, Au DH. Protocol and pilot testing: The feasibility and acceptability of a nurse-led telephone-based palliative care intervention for patients newly diagnosed with lung cancer. Contemp Clin Trials. 2018 Jan;64:30-34. doi: 10.1016/j.cct.2017.11.013. Epub 2017 Nov 23. No abstract available.
citation: Sullivan DR, Chan B, Lapidus JA, Ganzini L, Hansen L, Carney PA, Fromme EK, Marino M, Golden SE, Vranas KC, Slatore CG. Association of Early Palliative Care Use With Survival and Place of Death Among Patients With Advanced Lung Cancer Receiving Care in the Veterans Health Administration. JAMA Oncol. 2019 Dec 1;5(12):1702-1709. doi: 10.1001/jamaoncol.2019.3105.
citation: Sullivan DR, Ganzini L, Delorit MA, Slatore CG, Vranas KC, Golden SE, Hansen L. Transcending silos and building relationships: A qualitative study of palliative care use and integration in a national health system. [Abstract]. American journal of respiratory and critical care medicine. 2020 Nov 1; 201(B22):A2820.
citation: Sullivan DR, Slatore CG, Stone K, Nugent S, Kern J, Farris M, Roszenweig K, Swanson S, J Wisnivesky JP. Associations between Treatment and Team Composition with Decisional Regret among Patients with Early Stage Lung Cancer. [Abstract]. American journal of respiratory and critical care medicine. 2020 Nov 1; 201(B22):A4726.
citation: Vranas KC, Plinke W, Bourne D, Kansagara D, Lee RY, Kross EK, Slatore CG, Sullivan DR. The influence of POLST on treatment intensity at the end of life: A systematic review. J Am Geriatr Soc. 2021 Dec;69(12):3661-3674. doi: 10.1111/jgs.17447. Epub 2021 Sep 22.
citation: Hedstrom GH, Hooker ER, Howard M, Shull S, Golden SE, Deffebach ME, Gorman JD, Murphy K, Fabbrini A, Melzer AC, Slatore CG. The Chain of Adherence for Incidentally Detected Pulmonary Nodules after an Initial Radiologic Imaging Study: A Multisystem Observational Study. Ann Am Thorac Soc. 2022 Aug;19(8):1379-1389. doi: 10.1513/AnnalsATS.202111-1220OC.