What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) include chemotherapy, radiation therapy, targeted therapy, and immunotherapy. Chemotherapy can cause nausea, vomiting, hair loss, fatigue, and increased infection risk. Radiation therapy may lead to skin irritation, fatigue, and damage to nearby organs. Targeted therapies often cause skin rashes, diarrhea, and liver problems. Immunotherapy can result in immune-related side effects such as inflammation of the lungs, liver, or other organs. Palliative care focuses on managing these side effects to improve quality of life.

What prior FDA approvals exist?

The FDA has approved several treatments for Non-Small Cell Lung Cancer (NSCLC) that align with supportive and palliative care models like POISE. Key approvals include immunotherapies such as pembrolizumab (Keytruda) and atezolizumab (Tecentriq), which are used to enhance the body's immune response against cancer cells. Targeted therapies like osimertinib (Tagrisso) and alectinib (Alecensa) have been approved for tumors with specific genetic mutations. Additionally, palliative care interventions, including radiation therapy and endobronchial techniques, are used to manage symptoms and improve quality of life in advanced NSCLC patients.

What other types of research exist?

Promising alternatives to POISE for NSCLC patients include: 1) Integrative therapies such as acupuncture, massage therapy, and Reiki, which have shown benefits in managing pain and anxiety. 2) Pharmaceutical alternatives to morphine, including other opioids and non-opioid analgesics, tailored to individual patient needs. 3) Community-based episodic models of short-term integrated palliative and supportive care (SIPS), which focus on providing comprehensive care based on patient and caregiver feedback. These approaches aim to enhance symptom management and overall quality of life for NSCLC patients.

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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

No Placebo-Only Group

Summary

This trial tests a supportive care model called POISE for patients with advanced lung cancer. It involves multiple sessions with a palliative care specialist to help manage emotional and psychological issues. The goal is to see if this approach reduces patient distress and improves their ability to cope 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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 20 weeks

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Feasibility of POISE

Secondary study objectives

Acceptability

Distress related to prognostic uncertainty

Documentation of Goals and Values

+1 more

Other study objectives

Psychological Distress

Uncertainty tolerance

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 4Eligibility criteria met

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.