Stepped Palliative Care Versus Early Integrated Palliative Care in Patients With Advanced Lung Cancer (STEP PC)

May 5, 2025 updated by: Jennifer Temel, MD, Massachusetts General Hospital

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
507

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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
Other: Stepped PC
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
Experimental: 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
Other: Early Integrated PC
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
24 Weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
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).
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)
Length of stay in hospice as collected per medical record review
From hospice enrollment until death during study period (i.e. 12-month follow up)
Palliative Care Resource Utilization
Time Frame: week 24
Mean number of palliative care visits
week 24

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cost-effectiveness
Time Frame: up to 5 years
Cost effectiveness as assessed by data collection from the medical record, hospital cost accounting systems, and patient report as per the EuroQOL
up to 5 years
Patients' Prognostic Understanding
Time Frame: last assessment collected during study or prior to death
Perception of Treatment and Prognosis Questionnaire (PTPQ)
last assessment collected during study or prior to death
Health Care Utilization
Time Frame: prior to death or end of study period
Healthcare utilization as measured the means and proportion of patients who experience emergency department visits, hospital admission, and chemotherapy administration at the end of life between the two groups.
prior to death or end of study period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Massachusetts General Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jennifer Temel, MD, Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 6, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 9, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 15, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 17-471
  • R01CA215188 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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