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Palliative Care

Palliative Care Approaches for Lung Cancer (STEP PC Trial)

N/A

Waitlist Available

Led By Jennifer Temel, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

STEP PC Trial Summary

This trial is testing different methods of providing palliative care to people with lung cancer, to see what works best.

Who is the study for?

This trial is for adults over 18 with advanced lung cancer or mesothelioma, who are not aiming for a cure and were informed of their condition within the last 12 weeks. They should be able to perform daily activities with varying degrees of ease and must understand English or Spanish. Those already in palliative care or hospice, or with certain cognitive/psychiatric conditions cannot join.Check my eligibility

What is being tested?

The study compares two types of palliative care: 'Early Integrated Palliative Care' (EIPC) which starts soon after diagnosis, versus 'Stepped Palliative Care' (SPC), which scales up as needed. The goal is to see which approach better supports patients' quality of life during treatment.See study design

What are the potential side effects?

Since this trial focuses on palliative care approaches rather than medications, it does not have typical drug side effects. However, participants may experience different levels of emotional comfort or distress depending on how well the palliative care meets their personal needs.

STEP PC Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Establish that stepped PC is non-inferior to early integrated PC in improving patients' QOL, as measured by the FACT-L

Secondary outcome measures

Assess whether stepped PC is non-inferior to early integrated PC with respect to length of stay in hospice

Assess whether stepped PC is non-inferior to early integrated PC with respect to patient-clinician communication about EOL care preferences

Compare the superiority of stepped PC versus early integrated PC with respect to resource utilization

+1 more

Other outcome measures

Compare patients' coping as measured by the Brief Cope between stepped PC and early integrated PC

Compare patients' depression as measured by the Patient Health Questionnaire-9 (PHQ-9) between stepped PC and early integrated PC

Compare patients' prognostic understanding as measured by the Perception of Treatment and Prognosis Questionnaire between stepped PC and early integrated PC

+2 more

STEP PC Trial Design

2Treatment groups

Experimental Treatment

Group I: Stepped PCExperimental Treatment1 Intervention

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

Group II: Early Integrated PCExperimental Treatment1 Intervention

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,929 Previous Clinical Trials

13,197,795 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,658 Previous Clinical Trials

40,923,979 Total Patients Enrolled

Jennifer Temel, MDPrincipal Investigator - Massachusetts General Hospital

Massachusetts General Hospital, Massachusetts General Physicians Organization Inc

Washington University School Of Medicine (Medical School)

Brigham & Women'S Hospital (Residency)

11 Previous Clinical Trials

4,914 Total Patients Enrolled

Media Library

Early Integrated PC (Palliative Care) Clinical Trial Eligibility Overview. Trial Name: NCT03337399 — N/A

Lung Cancer Research Study Groups: Early Integrated PC, Stepped PC

Lung Cancer Clinical Trial 2023: Early Integrated PC Highlights & Side Effects. Trial Name: NCT03337399 — N/A

Early Integrated PC (Palliative Care) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03337399 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people have opted to participate in this research endeavor?

"A total of 510 appropriately qualified participants are needed to help conduct this medical experiment. At present, two primary sites - Duke University in Durham and Massachusetts General Hospital in Boston - can be used for patient enrolment."

Answered by AI

Are there any available vacancies for participants in this trial?

"Per clinicaltrials.gov, this medical experiment is presently recruiting participants and has been active since February 1st 2018, with the most recent update made on August 24th 2022."

Answered by AI

Recent research and studies

BMJ OpenJournal

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

Post, Kathryn E, Lauren B Heuer, Arif H Kamal, Pallavi Kumar, Madeleine Elyze, Sarah Griffith, Jacqueline Han, et al.. 2022. “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. BMJ. doi:10.1136/bmjopen-2021-057591.

Journal of Palliative MedicineJournal

Petrillo, Laura A., Areej El-Jawahri, Lauren B. Heuer, Kathryn Post, Emily R. Gallagher, Chardria Trotter, Madeleine Elyze, et al.. 2022. “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”. Journal of Palliative Medicine. Mary Ann Liebert Inc. doi:10.1089/jpm.2022.0049.

clinicaltrials.govStudy

Stepped Palliative Care Versus Early Integrated Palliative Care in Patients With Advanced Lung Cancer

Jennifer Temel, MD 2018. "Stepped Palliative Care Versus Early Integrated Palliative Care in Patients With Advanced Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03337399.