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

• ClinicalTrials.gov Identifier: NCT03337399
• Recruitment Status: Active, not recruiting
• First Posted: November 9, 2017
• Last Update Posted: January 25, 2023
• Sponsor: Massachusetts General Hospital
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): Jennifer Temel, MD, Massachusetts General Hospital

Tracking Information

• First Submitted Date: November 6, 2017
• First Posted Date: November 9, 2017
• Last Update Posted Date: January 25, 2023
• Actual Study Start Date: March 1, 2018
• Estimated Primary Completion Date: July 1, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 30, 2017)

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

Original Primary Outcome Measures (submitted: November 6, 2017)

Establish that stepped PC is non-inferior to early integrated PC in improving patients' QOL, as measured by the FACT-L [ Time Frame: up to 24 Weeks ]

Quality of life as measured by the Functional Assessment of Cancer Therapy-Lung

Current Secondary Outcome Measures (submitted: April 25, 2021)

• 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
• 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
• 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
• 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

Original Secondary Outcome Measures (submitted: November 6, 2017)

• 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 2 years ]
  Communication about EOL care preferences as measured by patient self-report of communication about their wishes if they were dying
• Assess whether stepped PC is non-inferior to early integrated PC with respect to length of stay in hospice [ Time Frame: up to 2 years ]
  Length of stay in hospice as collected per medical record review
• Compare the superiority of stepped PC versus early integrated PC with respect to resource utilization [ Time Frame: up to 2 years ]
  Utilization of PC services as per medical record review

Current Other Pre-specified Outcome Measures (submitted: January 22, 2023)

• 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
• 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
• 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)
• 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)
• 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.

Original Other Pre-specified Outcome Measures (submitted: November 6, 2017)

• Compare cost effectiveness of stepped PC versus early integrated PC [ Time Frame: up to 2 years ]
  cost effectiveness will be assessed by data collection from the medical record, hospital cost accounting systems, and patient report as per the EuroQOL
• Establish that stepped PC is non-inferior to early integrated PC in improving patients' depression, as measured by the PHQ-9 Compare depression between patients on stepped PC versus early integrated PC [ Time Frame: up to 24 weeks ]
  Depression will be measured by the Patient Health Questionnaire-9
• Establish that stepped PC is non-inferior to early integrated PC in improving patients' coping as measured by the Brief Cope [ Time Frame: up to 24 weeks ]
  Coping will be measured by the Brief Cope
• Establish that stepped PC is non-inferior to early integrated PC in improving patient's prognostic understanding as measured by the Perception of Treatment and Prognosis Questionnaire [ Time Frame: up to 24 weeks ]
  prognostic understanding will be measured using the Perception of Treatment and Prognosis Questionnaire (PTPQ)

Descriptive Information

• Brief Title: Stepped Palliative Care Versus Early Integrated Palliative Care in Patients With Advanced Lung Cancer
• Official Title: Randomized Trial of Stepped Palliative Care Versus Early Integrated Palliative Care in Patients With Advanced Lung Cancer
• Brief Summary: 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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care
• Condition: Lung Cancer

Intervention

• 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
• 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

Study Arms

• 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
  Intervention: Other: Stepped PC
• 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
  Intervention: Other: Early Integrated PC

Publications *

• Petrillo 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.
• Post 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.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: November 1, 2021): 510
• Original Estimated Enrollment (submitted: November 6, 2017): 480
• Estimated Study Completion Date: December 31, 2023
• Estimated Primary Completion Date: July 1, 2023 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03337399
• Other Study ID Numbers: 17-471; R01CA215188 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Jennifer Temel, MD, Massachusetts General Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Massachusetts General Hospital
• Original Study Sponsor: Same as current
• Collaborators: National Cancer Institute (NCI)

Investigators

• Principal Investigator: Jennifer Temel, MD; Massachusetts General Hospital

• PRS Account: Massachusetts General Hospital
• Verification Date: January 2023