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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03337399
Recruitment Status : Active, not recruiting
First Posted : November 9, 2017
Last Update Posted : January 25, 2023
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jennifer Temel, MD, Massachusetts General Hospital

Study Description
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Brief Summary:
This research study is evaluating ways to provide palliative care to patients who have recently been diagnosed with lung cancer

Condition or disease Intervention/treatment Phase
Lung Cancer Other: Stepped PC Other: Early Integrated PC Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 510 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Randomized Trial of Stepped Palliative Care Versus Early Integrated Palliative Care in Patients With Advanced Lung Cancer
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : July 1, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Establish that stepped PC is non-inferior to early integrated PC in improving patients' QOL, as measured by the FACT-L [ Time Frame: 24 Weeks ]
    Quality of life as measured by the Functional Assessment of Cancer Therapy-Lung


Secondary Outcome Measures :
  1. Assess whether stepped PC is non-inferior to early integrated PC with respect to patient-clinician communication about EOL care preferences [ Time Frame: up to 5 years ]
    Communication about EOL care preferences as measured by patient self-report of communication about their wishes if they were dying

  2. Assess whether stepped PC is non-inferior to early integrated PC with respect to length of stay in hospice [ Time Frame: up to 5 years ]
    Length of stay in hospice as collected per medical record review

  3. Compare the superiority of stepped PC versus early integrated PC with respect to resource utilization [ Time Frame: up to 5 years ]
    Utilization of PC services as per medical record review

  4. Evaluate whether stepped PC is non-inferior to early integrated PC in improving patients' QOL, as measured by the FACT-L [ Time Frame: up to 48 weeks ]
    Quality of life as measured by the Functional Assessment of Cancer Therapy-Lung


Other Outcome Measures:
  1. Compare the superiority of stepped PC versus early integrated PC with respect to 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

  2. Compare patients' coping as measured by the Brief Cope between stepped PC and early integrated PC [ Time Frame: up to 48 weeks ]
    Coping as measured by the Brief Cope

  3. Compare patients' prognostic understanding as measured by the Perception of Treatment and Prognosis Questionnaire between stepped PC and early integrated PC [ Time Frame: up to 48 weeks ]
    Prognostic understanding as per the Perception of Treatment and Prognosis Questionnaire (PTPQ)

  4. Compare patients' depression as measured by the Patient Health Questionnaire-9 (PHQ-9) between stepped PC and early integrated PC [ Time Frame: up to 48 weeks ]
    Depression as measured by the Patient Health Questionnaire-9 (PHQ-9)

  5. Health care utilization [ Time Frame: up to 5 years ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03337399


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Massachusetts General Hospital
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Jennifer Temel, MD Massachusetts General Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jennifer Temel, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03337399    
Other Study ID Numbers: 17-471
R01CA215188 ( U.S. NIH Grant/Contract )
First Posted: November 9, 2017    Key Record Dates
Last Update Posted: January 25, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jennifer Temel, MD, Massachusetts General Hospital:
Lung Cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases