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

NCT03007953 | Completed Results DMC

• 1 other identifier: NRI 15-456
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 3

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.

Conditions

Lung Cancer

Keywords

Palliative Care; Supportive Care

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Functional Assessment of Cancer Therapy-Lung Total Outcome Index Score at Final Visit

  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 Outcomes (1)

• Change From Baseline in Patient Satisfaction of Care at Final Visit

  Baseline and 3 Months

Study Arms (2)

Intervention

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

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.

Interventions

Palliative Care BEHAVIORAL

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.

Also known as: Supportive Care

Intervention

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (3)

Birmingham VA Medical Center, Birmingham, AL

Birmingham, Alabama, 35233-1927, United States

Location

VA Portland Health Care System, Portland, OR

Portland, Oregon, 97239, United States

Location

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, 98108-1532, United States

Location

Related Publications (8)

• 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.

  PMID: 28777716 RESULT

• 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.

  PMID: 28379812 RESULT

• 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.

  PMID: 29175560 RESULT

• 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.

  PMID: 31536133 RESULT

• 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.

  RESULT

• 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.

  RESULT

• 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.

  PMID: 34549418 RESULT

• 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.

  PMID: 35167780 RESULT

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Dr. Lynn F. Reinke
• Organization: Department of Veterans Affairs

Lynn.Reinke1@va.gov

206-277-4186

Study Officials

• Lynn F. Reinke, PhD ARNP

  VA Puget Sound Health Care System Seattle Division, Seattle, WA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2016
• First Posted: January 2, 2017
• Study Start: December 5, 2016
• Primary Completion: December 11, 2019
• Study Completion: December 11, 2019
• Last Updated: July 27, 2023
• Results First Posted: October 7, 2021

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)