Lung CancerSTEP PCNCT03337399
Stepped Palliative Care Versus Early Integrated Palliative Care in Patients With Advanced Lung Cancer
A study testing Stepped PC and Early Integrated PC in people with Lung Cancer, run by Massachusetts General Hospital at 3 sites in United States.
Trial summary
This research study is evaluating ways to provide palliative care to patients who have recently been diagnosed with lung cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Stepped PC and Early Integrated PC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 507 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Feb 2018to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Already receiving outpatient PC or hospice services
- Cognitive or psychiatric conditions as determined by the treating oncologist to prohibit study consent or participation
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Duke University
Durham, North Carolina, 27710
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Randomized Trial of Stepped Palliative Care Versus Early Integrated Palliative Care in Patients With Advanced Lung Cancer
This research study is evaluating ways to provide palliative care to patients who have recently been diagnosed with lung cancer
Read the detailed description
Patients with serious cancers, like advanced lung cancer, often experience physical symptoms, such as pain or shortness of breath. In addition, both patients and their loved ones (family and friends) often feel worried or sad about their cancer diagnosis.
Research has shown that early involvement of a team of clinicians that specialize in lessening (or "palliating") many of these distressing physical and emotional symptoms and in helping patients and their family cope with a serious illness improves patients' and their loved ones' experience with their cancer. This team is called "palliative care," and consists of physicians and advanced practice nurses (or "nurse practitioners") who work closely and collaboratively with your oncology team to care for the participant and the participant's loved ones. Research shows that when the palliative care team works closely with the oncology team to care for patients with advanced cancer, they may have better symptom control, quality of life, and mood and their loved ones feel less distressed.
This study will compare two different strategies for scheduling participant's visits with the palliative care clinician. The first strategy is to schedule the participant to meet with the palliative care clinician regularly each month. The investigators call this strategy "early integrated palliative care".
The second strategy is to schedule the participant to meet with the palliative care clinician after the participant is admitted to the hospital or if the participant's oncology team needs to change the participant cancer treatment, as these are times when the participant is likely to have health issues that the palliative care clinician can help with. The investigators will also monitor the participant's quality of life regularly. If the study team determines that the participant quality of life worsens, the investigators will increase the frequency of the participant's visits with the palliative care clinician to monthly appointments. The investigators call this strategy "stepped palliative care" because the investigators step up the frequency of the participant palliative care visits if the participant's quality of life worsens during the participant cancer treatment.
No matter which strategy the participant is taking part in, the participant will still be able to request additional palliative care visits outside of the study schedule if the participant feel they need them.
- Conditions
- Lung Cancer
- Being tested
- Stepped PC, Early Integrated PC
- Keywords
- Lung Cancer
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stepped PCOther
Palliative Care is involvement of a team of clinicians that specialize in lessening (or "palliating") many of these distressing physical and emotional symptoms and in helping patients and their family cope with a serious illness improves patients' and their loved ones' experience with their cancer
Early Integrated PCOther
Palliative Care is involvement of a team of clinicians that specialize in lessening (or "palliating") many of these distressing physical and emotional symptoms and in helping patients and their family cope with a serious illness improves patients' and their loved ones' experience with their cancer
| Study group | Role | What they receive |
|---|---|---|
| Stepped PC | Experimental | * 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 Receives: Other: Stepped PC |
| Early Integrated PC | Experimental | * 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 Receives: Other: Early Integrated PC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-reported Quality of Life
Quality of life as measured by the Functional Assessment of Cancer Therapy-Lung Range 0-136 with higher scores indicating better quality of life
Measured: 24 Weeks
Secondary outcomes (3)
Proportion of Patients Who Self-report Discussing Their End of Life Care Preferences With Their Clinicians
Compare the proportion of patients who report that they discussed their end-of-life care preferences with their clinicians based on a single item from the perceptions of prognosis and treatment questionnaire (PTPQ). The PTPQ includes an item that measures patient report of communication about their wishes if they were dying (yes vs. no).
Measured: 48 weeks (or last assessment prior to death if before 48 weeks)
Length of Stay in Hospice
Length of stay in hospice as collected per medical record review
Measured: From hospice enrollment until death during study period (i.e. 12-month follow up)
Palliative Care Resource Utilization
Mean number of palliative care visits
Measured: week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2017
- Study start1 Feb 2018
- Primary completion1 Jul 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 507 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Jennifer Temel, MD, Massachusetts General Hospital
- Investigators
- Jennifer Temel, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03337399
- Sponsor's protocol ID
- 17-471
- Other IDs
- R01CA215188
- Acronym
- STEP PC
- Status last verified
- Jul 2026
- First submitted
- 6 Nov 2017
- Last updated
- 3 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Temel 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.
PubMed 38824442Petrillo 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.
PubMed 35588200Post 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.
PubMed 35144954
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Stepped Palliative Care Versus Early Integrated Palliative Care in Patients With Advanced Lung Cancer
- ClinicalTrials.gov ID
- NCT03337399
- Acronym / sponsor ID
- STEP PC / 17-471
- Conditions
- Lung Cancer
- Keywords
- Lung Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 507 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 9 Nov 2017 (actual)
- Results
- Posted 3 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is evaluating ways to provide palliative care to patients who have recently been diagnosed with lung cancer
Detailed description
Patients with serious cancers, like advanced lung cancer, often experience physical symptoms, such as pain or shortness of breath. In addition, both patients and their loved ones (family and friends) often feel worried or sad about their cancer diagnosis.
Research has shown that early involvement of a team of clinicians that specialize in lessening (or "palliating") many of these distressing physical and emotional symptoms and in helping patients and their family cope with a serious illness improves patients' and their loved ones' experience with their cancer. This team is called "palliative care," and consists of physicians and advanced practice nurses (or "nurse practitioners") who work closely and collaboratively with your oncology team to care for the participant and the participant's loved ones. Research shows that when the palliative care team works closely with the oncology team to care for patients with advanced cancer, they may have better symptom control, quality of life, and mood and their loved ones feel less distressed.
This study will compare two different strategies for scheduling participant's visits with the palliative care clinician. The first strategy is to schedule the participant to meet with the palliative care clinician regularly each month. The investigators call this strategy "early integrated palliative care".
The second strategy is to schedule the participant to meet with the palliative care clinician after the participant is admitted to the hospital or if the participant's oncology team needs to change the participant cancer treatment, as these are times when the participant is likely to have health issues that the palliative care clinician can help with. The investigators will also monitor the participant's quality of life regularly. If the study team determines that the participant quality of life worsens, the investigators will increase the frequency of the participant's visits with the palliative care clinician to monthly appointments. The investigators call this strategy "stepped palliative care" because the investigators step up the frequency of the participant palliative care visits if the participant's quality of life worsens during the participant cancer treatment.
No matter which strategy the participant is taking part in, the participant will still be able to request additional palliative care visits outside of the study schedule if the participant feel they need them.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stepped PC | Experimental | Other: Stepped PC* 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 |
| Early Integrated PC | Experimental | Other: Early Integrated PC* 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Already receiving outpatient PC or hospice services
- Cognitive or psychiatric conditions as determined by the treating oncologist to prohibit study consent or participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stepped PCPalliative Care is involvement of a team of clinicians that specialize in lessening (or "palliating") many of these distressing physical and emotional symptoms and in helping patients and their family cope with a serious illness improves patients' and their loved ones' experience with their cancer | Other | Stepped PC |
| Early Integrated PCPalliative Care is involvement of a team of clinicians that specialize in lessening (or "palliating") many of these distressing physical and emotional symptoms and in helping patients and their family cope with a serious illness improves patients' and their loved ones' experience with their cancer | Other | Early Integrated PC |
Primary outcome
Patient-reported Quality of Life
Time frame: 24 Weeks
Quality of life as measured by the Functional Assessment of Cancer Therapy-Lung Range 0-136 with higher scores indicating better quality of life
3 secondary outcomes
Proportion of Patients Who Self-report Discussing Their End of Life Care Preferences With Their Clinicians
Time frame: 48 weeks (or last assessment prior to death if before 48 weeks)
Length of Stay in Hospice
Time frame: From hospice enrollment until death during study period (i.e. 12-month follow up)
Palliative Care Resource Utilization
Time frame: week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38824442Temel 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.
- Derived from this study: PubMed 35588200Petrillo 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.
- Derived from this study: PubMed 35144954Post 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Temel, MD principal investigator
Massachusetts General Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stepped PC and Early Integrated PC in people with Lung Cancer, run by Massachusetts General Hospital at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-reported Quality of Life (time frame: 24 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03337399, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.