Patient-centered, Optimal Integration of Survivorship and Palliative Care

The goal of this study is to develop and test the feasibility of a supportive care model (POISE) for patients with metastatic Non-small Cell Lung Cancer (NSCLC). The main questions are

• is POISE feasible to deliver and acceptable to patients
• what is the effect of POISE on the distress patients feel related to their uncertain future, their confidence in their ability to manage cancer, and their understanding about what to expect Participants in the randomized controlled trial will receive either the new supportive care model, POISE, which consists of four visits with a trained palliative care clinician, or care as usual, and will be asked to complete three surveys.

Study Overview

• Status: Recruiting
• Conditions: Carcinoma, Non-Small-Cell Lung; Nonsmall Cell Lung Cancer; Palliative Care; Survivorship; Targeted Therapy; Stage IV Non-small Cell Lung Cancer; EGFR Positive Non-small Cell Lung Cancer; ALK-positive Non-small Cell Lung Cancer
• Intervention / Treatment: Behavioral: POISE

Detailed Description

This research study involves an intervention consisting of four sessions with palliative care specialists who have been additionally trained to evaluate and address the specific psychosocial issues and health-promoting behaviors of patients with NSCLC.

The research study procedures include:

• Four 60-minute visits with a trained palliative care clinician
• Questionnaires and an exit interview
• Chart Review

It is expected that about 70 participants currently receiving targeted therapy at Massachusetts General Hospital for lung cancer will take part in this research study: 10 patients in an open pilot study, followed by 60 patients in a randomized controlled trial.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laura A Petrillo, MD; Phone Number: (617) 724-4000; Email: lpetrillo2@mgh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Massachusetts General Hospital
      • Contact: Laura A. Petrillo, MD; Phone Number: 617-724-4000; Email: lpetrillo2@mgh.harvard.edu
      • Principal Investigator: Laura A. Petrillo, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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 Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: POISE; 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	Behavioral: POISE; POISE (Patient-centered, Optimal Integration of Survivorship and palliative carE) is a brief, population-specific intervention that consists of four sessions with palliative care specialists who have been additionally trained to evaluate and address the specific psychosocial issues and health-promoting behaviors of patients with long, uncertain cancer trajectories.; Other Names: palliative care intervention
No Intervention: Usual care; Patients randomized to usual care will receive usual oncology care. They may access standard palliative care as clinically indicated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of POISE - enrollment	≥60% enrollment among eligible patientsamong patients in the POISE group	20 weeks
Feasibility of POISE - completion of all sessions among patients in intervention group	≥70% completion of all sessions in the intervention arm	20 weeks
Feasibility of POISE - completion of surveys in both arms	≥70% completion of all surveys in both arms	20 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self efficacy	Self-Efficacy of Management of Chronic Disease 6-Item Scale asks patients to rate their confidence in managing symptoms and activities related to chronic disease on a 1-10 scale, ranging from 1 (not at all confident) to 10 (totally confident).	12 weeks
Self efficacy	Self-Efficacy of Management of Chronic Disease 6-Item Scale asks patients to rate their confidence in managing symptoms and activities related to chronic disease on a 1-10 scale	20 weeks
Documentation of Goals and Values	The investigators will apply a previously developed natural language processing/machine learning (ML) algorithm to palliative care and oncology notes from the study period in order to identify goals of care conversations using an inductive supervised ML classifier. Notes with a predicted probability of greater than 0.5 will be classified as containing goals of care documentation.	20 weeks
Acceptability	4-item measure of satisfaction and comfort with the intervention	20 Weeks
Emotional coping with prognosis and prognostic awareness	Subscale of Prognostic Awareness Impact Scale	12 weeks
Emotional coping with prognosis and prognostic awareness	Subscale of Prognostic Awareness Impact Scale	20 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Uncertainty tolerance	Intolerance of Uncertainty-Short Form is a 12-item questionnaire with descriptions about ability to tolerate uncertainty, using a Likert scale of agreement from 1 to 5, with lower scores indicating low intolerance of uncertainty and high scores indicating high intolerance of uncertainty.	12 weeks
Psychological Distress	Hospital Anxiety and Depression Scale (HADS) is a 14-item questionnaire that contains two 7-item subscales assessing depression and anxiety symptoms during the past week, with higher scores indicating worse anxiety and depression.	12 weeks
Uncertainty tolerance	Intolerance of Uncertainty-Short Form is a 12-item questionnaire with descriptions about ability to tolerate uncertainty, using a Likert scale of agreement from 1 to 5, with lower scores indicating low intolerance of uncertainty and high scores indicating high intolerance of uncertainty.	20 weeks
Psychological Distress	Hospital Anxiety and Depression Scale (HADS) is a 14-item questionnaire that contains two 7-item subscales assessing depression and anxiety symptoms during the past week, with higher scores indicating worse anxiety and depression.	20 weeks
Multidimensional quality of life	Functional Assessment of Cancer Therapy-Lung, a quality of life measure	12 weeks
Multidimensional quality of life	Functional Assessment of Cancer Therapy-Lung, a quality of life measure	20 weeks
Hope and goal setting	Adult Trait Hope Scale	12 weeks
Hope and goal setting	Adult Trait Hope Scale	20 weeks

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Laura A Petrillo, MD, Massachusetts General Hospital

Publications and helpful links

General Publications

• Richard HA, Sarathy R, Rabideau DJ, Feldman J, Cartagena L, Patel H, Sequist LV, Park E, Jackson V, Greer JA, Temel JS, Petrillo LA. Blended palliative and survivorship care intervention (POISE) for patients with metastatic oncogene-driven non-small cell lung cancer: study protocol for a pilot randomised controlled trial. BMJ Open. 2025 Aug 13;15(8):e098075. doi: 10.1136/bmjopen-2024-098075.

Helpful Links

• Protocol paper

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2023
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: May 20, 2021
• First Submitted That Met QC Criteria: May 20, 2021
• First Posted (Actual): May 25, 2021

Study Record Updates

• Last Update Posted (Actual): November 24, 2025
• Last Update Submitted That Met QC Criteria: November 19, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Palliative care; survivorship; Carcinoma, Non-Small-Cell Lung; Targeted Therapy; Nonsmall Cell Lung Cancer; Stage IV Non-small Cell Lung Cancer; ALK-positive Non-small Cell Lung Cancer; EGFR Positive Non-small Cell Lung Cancer; ROS1 Positive Non-Small Cell Lung Cancer; RET Fusion positive Non-Small Cell Lung Cancer
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: 20-722; K08CA263549 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes