Clinical trial · Interventional
Stepped Palliative Care Versus Early Integrated Palliative Care in Patients With Advanced Lung Cancer
Randomized Trial of Stepped Palliative Care Versus Early Integrated Palliative Care in Patients With Advanced Lung Cancer
NCT03337399CI-TRIAL-00120315STEP PCcompletedN/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)
This research study is evaluating ways to provide palliative care to patients who have recently been diagnosed with lung cancer
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Early Integrated PC | Other | — | UNRESOLVED |
| Stepped PC | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Stepped PC
- description
- * Patients will receive Stepped PC * During step 1, patients will be scheduled to meet with the outpatient PC clinician within four weeks of study enrollment and after they are admitted to the hospital or have a change in their cancer treatment * Patients will complete the Functional Assessment of Cancer Therapy-Lung (FACT-L) to monitor their quality of life every six weeks and if their quality of life deteriorates substantially, they will "step up" to step 2 of the protocol * Patients who transition to step 2 will then meet with the PC clinician at least every four weeks for the remainder of their illness
- interventionNames
- Other: Stepped PC
- type
- EXPERIMENTAL
- label
- Early Integrated PC
- description
- * Patients will receive Early Integrated PC * Patients will meet with the PC clinician within four weeks of enrollment and at least every four weeks throughout their course of illness
- interventionNames
- Other: Early Integrated PC
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosed with advanced non-small cell lung cancer, small cell lung cancer, or mesothelioma, being treated with non-curative intent, and informed of advanced disease within the prior twelve weeks * Eastern Cooperative Oncology Group (ECOG) Performance Status from 0 (asymptomatic) to 2 (symptomatic and in bed \<50% of the day) * The ability to read and respond to questions in English or Spanish * Primary cancer care at one of the three participating sites * Age \> 18 years Exclusion Criteria: * Already receiving outpatient PC or hospice services * Cognitive or psychiatric conditions as determined by the treating oncologist to prohibit study consent or participation
References
Publications (3)
- DERIVEDTemel JS, Jackson VA, El-Jawahri A, Rinaldi SP, Petrillo LA, Kumar P, McGrath KA, LeBlanc TW, Kamal AH, Jones CA, Rabideau DJ, Horick N, Pintro K, Gallagher Medeiros ER, Post KE, Greer JA. Stepped Palliative Care for Patients With Advanced Lung Cancer: A Randomized Clinical Trial. JAMA. 2024 Aug 13;332(6):471-481. doi: 10.1001/jama.2024.10398. PMID 38824442
- DERIVEDPetrillo LA, El-Jawahri A, Heuer LB, Post K, Gallagher ER, Trotter C, Elyze M, Vyas C, Plotke R, Turk YR, Han J, Temel JS, Greer JA. Health-Related Quality of Life and Depression Symptoms in a Cross Section of Patients with Advanced Lung Cancer before and during the COVID-19 Pandemic. J Palliat Med. 2022 Nov;25(11):1639-1645. doi: 10.1089/jpm.2022.0049. Epub 2022 May 19. PMID 35588200
- DERIVEDPost KE, Heuer LB, Kamal AH, Kumar P, Elyze M, Griffith S, Han J, Friedman F, Jackson A, Trotter C, Plotke R, Vyas C, Jackson V, Rabideau DJ, Greer JA, Temel JS. Study protocol for a randomised trial evaluating the non-inferiority of stepped palliative care versus early integrated palliative care for patients with advanced lung cancer. BMJ Open. 2022 Feb 10;12(2):e057591. doi: 10.1136/bmjopen-2021-057591. PMID 35144954