POISE for Stage IV Non-small Cell Lung Cancer

This study is testing a new supportive care program called POISE (Patient-centered, Optimal Integration of Survivorship and palliative carE) for people with advanced (Stage IV) non-small cell lung cancer (NSCLC). You may be eligible if you have NSCLC with specific genetic changes (ALK, EGFR, ROS1, RET) and are currently receiving targeted therapy. The POISE program involves four sessions with a palliative care specialist. Researchers want to see if POISE is practical to deliver and acceptable to patients, and if it helps with distress about the future, confidence in managing cancer, and understanding what to expect. This study plans to enroll about 70 participants.

Study design
This is an interventional study that will first include 10 patients in an open pilot study, followed by 60 patients in a randomized controlled trial. Participants will either receive the POISE program or usual care.
What's involved
You would have four 60-minute visits with a palliative care clinician, complete questionnaires, and have an exit interview. Your medical charts will also be reviewed.
Compensation
Not stated in the trial record.
Follow-up
The primary goals of the study are measured at 20 weeks, which includes completion of sessions and surveys.

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NCT04900935

Patient-centered, Optimal Integration of Survivorship and Palliative Care

Recruiting
NAAges 18+InterventionalSupportive care
Massachusetts General Hospital
~70 participants
Updated 2025-11-24 on ClinicalTrials.gov
What's tested:POISE

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility of POISE - enrollment
Measured over 20 weeks
+2 more outcomes measured
Stage IV Non-small Cell Lung Cancer
Targeted Therapy
Nonsmall Cell Lung Cancer
Carcinoma, Non-Small-Cell Lung
ALK-positive Non-small Cell Lung Cancer
EGFR Positive Non-small Cell Lung Cancer
Palliative Care
Survivorship
1 sites across 1 states
Massachusetts1
  • Laura A Petrillo, MD · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital

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Eligibility criteria

Inclusion

Age 18 or older
MGH Cancer Center patient
Within 6 months of diagnosis of metastatic NSCLC with oncogenic driver mutation (EGFR, ALK, ROS1, RET)
Receiving targeted therapy
Ability to respond in English or Spanish

Exclusion

Cognitive impairment or serious mental illness that limits ability to provide informed consent
Need for urgent palliative care or hospice referral
Pregnant women
Prisoners
  • Feasibility of POISE - enrollment20 weeks

    ≥60% enrollment among eligible patientsamong patients in the POISE group

  • Feasibility of POISE - completion of all sessions among patients in intervention group20 weeks

    ≥70% completion of all sessions in the intervention arm

  • Feasibility of POISE - completion of surveys in both arms20 weeks

    ≥70% completion of all surveys in both arms