Survivorship and Palliative Care Model for Lung Cancer

Overseen By Laura A Petrillo, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Must be taking: Targeted therapy

Disqualifiers: Cognitive impairment, Serious mental illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 20 weeks

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new supportive care model called POISE for patients with metastatic Non-small Cell Lung Cancer (NSCLC). Researchers aim to determine if POISE reduces patients' distress about their uncertain future, boosts their confidence in managing cancer, and improves their understanding of what to expect. Participants will either receive POISE care, which includes sessions with a trained palliative care clinician, or continue with their usual care. Ideal candidates for this trial are those treated at the MGH Cancer Center, diagnosed with metastatic NSCLC within the last six months, and currently receiving targeted therapy. As an unphased trial, this study offers patients the chance to contribute to innovative care strategies that could enhance their quality of life.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your current treatment, as the trial involves supportive care rather than changes to your cancer treatment.

What prior data suggests that the POISE supportive care model is safe for patients with metastatic Non-small Cell Lung Cancer?

Research has shown that the POISE treatment is generally safe. Although specific safety data for this exact version is not available, similar supportive care methods typically carry very low risks. To protect participants, the researchers created a safety plan during the development of POISE to ensure adherence to safety protocols.

As a supportive care approach rather than a medication, POISE focuses on reducing distress related to lung cancer and improving quality of life. There have been no reports of serious side effects with this type of care, which involves regular visits with a trained palliative care specialist. This ensures that the care provided is both safe and effective for patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the POISE intervention for lung cancer because it emphasizes a structured palliative care approach, which is distinct from the usual care. Unlike typical treatments that focus mainly on aggressive cancer therapies, POISE integrates regular meetings with specially trained palliative care clinicians. This model aims to provide holistic support through four 60-minute visits, addressing not only physical symptoms but also emotional and social needs. By incorporating personalized care and comprehensive chart reviews, this intervention hopes to enhance the quality of life for patients, making it a promising addition to current lung cancer care strategies.

What evidence suggests that the POISE model is effective for metastatic Non-small Cell Lung Cancer?

Research suggests that the POISE supportive care model, which participants in this trial may receive, could assist patients with advanced lung cancer by providing emotional support and aiding in coping with their diagnosis. Studies have shown that similar programs can boost patients' confidence in managing their illness and help them understand what to expect. Although solid data on POISE's effectiveness is not yet available, the approach aims to ease worries about the future, a significant concern for many patients. Early findings indicate that structured care programs like POISE might improve quality of life and emotional well-being. While specific data on POISE's effectiveness is still being gathered, its focus on comprehensive support shows promise for helping patients through their cancer journey. ^{1 2 3 5 6}

Who Is on the Research Team?

Laura A Petrillo, MD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I can communicate in English or Spanish.

My lung cancer was diagnosed within the last 6 months and has a specific mutation.

I am currently on targeted therapy for my condition.

Exclusion Criteria

I do not have any mental conditions that prevent me from understanding this study.

Prisoners

Pregnant women

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the POISE intervention, consisting of four 60-minute visits with a trained palliative care clinician

20 weeks

4 visits (in-person)

Follow-up

Participants are monitored for psychological distress, uncertainty tolerance, and self-efficacy through surveys and chart reviews

20 weeks

What Are the Treatments Tested in This Trial?

Interventions

• POISE

Trial Overview 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.

How Is the Trial Designed?

Group I: POISE Experimental Treatment 1 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 care Active Control 1 Intervention

Patients randomized to usual care will receive usual oncology care. They may access standard palliative care as clinically indicated.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

American Lung Association

Collaborator

Trials

32

Recruited

11,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A communication-priming intervention significantly improved the completion of 'Goals of Care' forms among 84 patients with advanced lung cancer, indicating that better communication can enhance patient engagement in care planning (RR 1.29, P = 0.004).

Despite the initial success in increasing GOC completion, the improvement was not sustained in follow-up audits, and there was no significant change in palliative care referral rates, highlighting the need for ongoing strategies to maintain these improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing 'Goals of Care' discussion and palliative care referral for patients with advanced lung cancer: an outpatient-based pilot project. Conduit, C., Thompson, M., Thomas, R., et al.[2021]

In a study of 205 patients with advanced non-small cell lung cancer (NSCLC) receiving anti-PD-1/PD-L1 therapy, the incidence of checkpoint inhibitor pneumonitis (CIP) was found to be 19%, significantly higher than the 3%-5% reported in clinical trials.

The study identified tumor histologic type as a potential risk factor for developing CIP, with a median onset time of 82 days and severe outcomes associated with higher-grade CIP, highlighting the need for improved monitoring and management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pneumonitis in Non-Small Cell Lung Cancer Patients Receiving Immune Checkpoint Immunotherapy: Incidence and Risk Factors. Suresh, K., Voong, KR., Shankar, B., et al.[2019]

In a study involving 23 patients with advanced non-small-cell lung cancer, common side effects of osimertinib treatment included coughing, itching, and tiredness, with shortness of breath and diarrhea becoming more prevalent after 4 months.

Despite experiencing side effects, patients reported high satisfaction with osimertinib and found it relatively easy to cope with these side effects, suggesting that the benefits of the treatment may outweigh the challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Experience of Symptoms and Side Effects when Treated with Osimertinib for Advanced Non-Small-Cell Lung Cancer: A Qualitative Interview Substudy. Rydén, A., Blackhall, F., Kim, HR., et al.[2022]

A comprehensive review of 41 randomized controlled trials involving 23,121 patients found that treatments combining chemotherapy with immune checkpoint inhibitors (ICIs) significantly increased the risk of treatment-related adverse events compared to ICI-only regimens.

Among the various ICI treatments, the combination of PD-L1 and CTLA-4 with chemotherapy had the highest risk of immune-related adverse events, with severe cases like myocarditis and pneumonitis showing notably high fatality rates, indicating the need for careful monitoring and management in patients receiving these therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toxicity spectrum of immunotherapy in advanced lung cancer: A safety analysis from clinical trials and a pharmacovigilance system. Yan, YD., Zhao, Y., Zhang, C., et al.[2022]

In a study of 64,950 patients with metastatic lung cancer, timely reporting of palliative care needs (91 to 31 days before death) was linked to a significant reduction in the use of aggressive treatments like chemotherapy and invasive ventilation near the end of life.

Patients who reported palliative care needs late (30 to 8 days before death) or very late (7 to 0 days before death) experienced more aggressive care, highlighting the importance of early palliative care integration for improving quality of life and reducing unnecessary interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Timing of palliative care needs reporting and aggressiveness of care near the end of life in metastatic lung cancer: A national registry-based study. Goldwasser, F., Vinant, P., Aubry, R., et al.[2019]

In a study of 1361 patients undergoing radiation therapy for locally advanced lung cancer, over half (53%) reported significant declines in their quality of life (QoL) by the end of treatment, indicating that treatment can have a substantial impact on patient well-being.

While clinician-reported adverse events (AEs) were linked to declines in QoL, the correlation was only moderate, suggesting that patient-reported outcomes (PROs) are crucial for understanding the full impact of treatment and may help identify when interventions are needed to improve patient experiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association Between Physician- and Patient-Reported Symptoms in Patients Treated With Definitive Radiation Therapy for Locally Advanced Lung Cancer in a Statewide Consortium. Wilkie, JR., Hochstedler, KA., Schipper, MJ., et al.[2022]

In a study of 120 newly diagnosed non-small-cell lung cancer patients, early integration of interdisciplinary palliative care significantly improved quality of life compared to standard oncological care, with better outcomes observed at 24 weeks.

Patients receiving early palliative care also experienced fewer depressive symptoms and improved nutritional status, highlighting the comprehensive benefits of this approach in managing NSCLC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Palliative Care in Patients With Non-Small-Cell Lung Cancer: A Randomized Controlled Trial in Southwest China. Chen, M., Yang, L., Yu, H., et al.[2022]

The Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) has been validated as a reliable tool for assessing symptoms and their impact on quality of life in patients undergoing phase I cancer trials, based on a study of 479 patients.

There were significant correlations between PRO-CTCAE items and measures of psychological distress and quality of life, particularly for mood-related items, indicating that PRO-CTCAE can effectively capture the patient experience in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Patient-Reported Outcomes to Describe the Patient Experience on Phase I Clinical Trials. Sedhom, R., Ferrell, B., Ruel, N., et al.[2022]

Preliminary evidence indicates that online supportive care interventions for individuals living with and beyond lung cancer are feasible and acceptable, although most studies are small pilot projects with limited high-level evidence.

Integrating online supportive care into cancer treatment pathways may enhance quality of life and emotional functioning while reducing symptom distress, highlighting the need for further research to expand these supportive care options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility, acceptability, and efficacy of online supportive care for individuals living with and beyond lung cancer: a systematic review. Curry, J., Patterson, M., Greenley, S., et al.[2022]

Early palliative care for patients with metastatic non-small-cell lung cancer significantly improved quality of life and mood, with higher FACT-L scores (98.0 vs. 91.5) compared to standard care after 12 weeks.

Patients receiving early palliative care experienced less aggressive end-of-life treatment (33% vs. 54%) and had longer median survival (11.6 months vs. 8.9 months), indicating that palliative care can enhance both life quality and longevity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early palliative care for patients with metastatic non-small-cell lung cancer. Temel, JS., Greer, JA., Muzikansky, A., et al.[2023]

In a study of 6982 elderly cancer patients, the median length of palliative radiotherapy was 14 days, while the median duration of hospice care was only 13 days, indicating that many patients received longer radiation treatment than the time they spent in hospice.

Breast and lung cancer patients tended to have longer radiotherapy courses but shorter hospice stays, suggesting that the treatment approach may not align with the patients' end-of-life care needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palliative radiation before hospice: the long and the short of it. Yeung, HN., Mitchell, WM., Roeland, EJ., et al.[2014]

Advancements in lung cancer treatment have improved short-term survival rates, but ongoing surveillance is crucial for managing long-term side effects and recurrence.

Integrating quality palliative care into the treatment plan for lung cancer patients after surgery is essential for maintaining function and enhancing quality of life, with an interdisciplinary approach effectively connecting patients to necessary support services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palliative care in lung cancer. Ferrell, B., Koczywas, M., Grannis, F., et al.[2021]

Palliative care significantly improves the quality of life for patients with advanced lung cancer by effectively managing symptoms and addressing various aspects of suffering, including physical and emotional needs.

Both the American Society of Clinical Oncology (ASCO) and the National Cancer Care Network (NCCN) recommend the early integration of palliative care into standard cancer treatment to enhance overall patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palliative Care in Lung Cancer. Shinde, AM., Dashti, A.[2017]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40812801/

study protocol for a pilot randomised controlled trial Blended palliative and survivorship care intervention (POISE) for patients with metastatic oncogene-driven non-small cell lung cancer: study ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12352232/

study protocol for a pilot randomised controlled trial - PMC Exploratory outcomes include acceptability, emotional coping with prognosis, self-efficacy for chronic disease management, prognostic awareness, quality of life ...

3. bmjopen.bmj.com bmjopen.bmj.com/content/bmjopen/15/8/e098075.full.pdf

driven non- small cell lung cancer The primary outcome measure of this trial is feasibility, which will be defined by ≥60% enrolment among eligible patients, ≥70% completion of ...

4. withpower.com withpower.com/trial/phase-carcinoma-non-small-cell-lung-8-2021-409c4

Survivorship and Palliative Care Model for Lung Cancer This trial tests a supportive care model called POISE for patients with advanced lung cancer. It involves multiple sessions with a palliative care ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04871412

The Thoracic Peri-Operative Integrative Surgical Care ... The Thoracic POISE project has the overarching goal of improving care for thoracic cancer patients by impacting HRQoL, reducing surgical adverse events, ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02845479

The Thoracic Peri-Operative Integrative Surgical Care ... The Thoracic-POISE Project has the overarching goal of improving care for thoracic cancer patients by impacting HRQoL, reducing surgical adverse events, ...