Clinical trial · Interventional
Palliative Care Interventions for Outpatients Newly Diagnosed With Lung Cancer: Phase II
NCT03007953CI-TRIAL-00068273PCI2completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Palliative Care | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention
- description
- 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).
- interventionNames
- Behavioral: Palliative Care
- type
- NO_INTERVENTION
- label
- Usual Care
- description
- 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.
Primary outcomes (1)
- measure
- Change From Baseline in Functional Assessment of Cancer Therapy-Lung Total Outcome Index Score at Final Visit
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
Show eligibility criteria text
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
References
Publications (8)
- RESULTReinke 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
- RESULTAslakson 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
- RESULTReinke 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
- RESULTSullivan 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
- RESULTSullivan 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.
- RESULTSullivan 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.
- RESULTVranas 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.