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Survivorship and Palliative Care Model for Lung Cancer

N/A
Recruiting
Led By Laura A Petrillo, 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
Receiving targeted therapy
Age 18 or older
Must not have
Cognitive impairment or serious mental illness that limits ability to provide informed consent
Need for urgent palliative care or hospice referral
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 20 weeks
Awards & highlights

Summary

This trial is developing a care model to help people with metastatic lung cancer cope with uncertainty and understand their prognosis and treatment goals, so they can live well with cancer.

Who is the study for?
This trial is for adults diagnosed with metastatic Non-small Cell Lung Cancer (NSCLC) within the last 6 months, who are receiving targeted therapy and can communicate in English or Spanish. It's specifically for patients at MGH Cancer Center. Pregnant women, prisoners, those needing urgent palliative care, or individuals with cognitive impairments that prevent informed consent are excluded.Check my eligibility
What is being tested?
The study is testing a new supportive care model called POISE designed for NSCLC patients. POISE involves four sessions with a trained clinician compared to standard care. The focus is on its feasibility, acceptability, and impact on patient distress about their future, cancer management confidence, and understanding of what to expect.See study design
What are the potential side effects?
Since POISE is a supportive care model rather than a medication or medical procedure, it does not have traditional side effects. However, discussing serious illness may cause emotional discomfort or distress.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am currently on targeted therapy for my condition.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any mental conditions that prevent me from understanding this study.
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I need immediate care to manage my cancer symptoms.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~20 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 20 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility of POISE
Secondary outcome measures
Acceptability
Distress related to prognostic uncertainty
Documentation of Goals and Values
+1 more
Other outcome measures
Psychological Distress
Uncertainty tolerance

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: POISEExperimental Treatment1 Intervention
The intervention will be a structured palliative care intervention in which patients will meet with a palliative care clinician who has been trained on a manual with specific topics to be covered in each of the four visits: Three surveys: baseline, 12-week, and 20-week post-enrollment Four 60-minute visits with a trained palliative care clinician Semi-structured exit interview Chart review
Group II: Usual careActive Control1 Intervention
Patients randomized to usual care will receive usual oncology care. They may access standard palliative care as clinically indicated.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Non-Small Cell Lung Cancer (NSCLC) include chemotherapy, targeted therapies, and immunotherapies. Chemotherapy works by killing rapidly dividing cancer cells, though it can also affect normal cells, leading to side effects. Targeted therapies, such as tyrosine kinase inhibitors, specifically target cancer cell mutations, offering a more precise treatment with potentially fewer side effects. Immunotherapies boost the body's immune system to recognize and attack cancer cells. These treatments are crucial for NSCLC patients as they can improve survival rates and quality of life. The POISE trial's focus on structured palliative care support highlights the importance of managing symptoms and improving patients' overall well-being alongside these treatments.

Find a Location

Who is running the clinical trial?

American Lung AssociationOTHER
31 Previous Clinical Trials
10,883 Total Patients Enrolled
Massachusetts General HospitalLead Sponsor
2,955 Previous Clinical Trials
13,212,588 Total Patients Enrolled
Laura A Petrillo, MDPrincipal InvestigatorMassachusetts General Hospital
1 Previous Clinical Trials
210 Total Patients Enrolled

Media Library

POISE Clinical Trial Eligibility Overview. Trial Name: NCT04900935 — N/A
~60 spots leftby Jan 2027
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