Patient-centered, Optimal Integration of Survivorship and Palliative Care

Study Overview
=================
Brief Summary
-----------------
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.

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 90 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 80 patients in a randomized controlled trial.

Official Title
-----------------
Patient-centered, Optimal Integration of Survivorship and Palliative Care

Conditions
-----------------
Targeted Therapy, Nonsmall Cell Lung Cancer, Stage IV Non-small 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

Intervention / Treatment
-----------------
* Behavioral: POISE


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: There will be two phases of this research study: 1) an open pilot of 10 patients to refine the intervention and study protocol, in which all patients receive the POISE intervention; followed by 2) a randomized controlled trial in which patients are randomized to receive either the POISE intervention or usual care.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: POISE<br>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<br>* 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.<br>* Other names: palliative care intervention;|
| No Intervention: Usual care<br>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 | At least 60% enrollment among eligible patients and 75% completion of all four sessions | 20 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability | >70% of patients reporting that they agree or strongly agree with the four measures of satisfaction and comfort with the intervention | 20 Weeks | 
| Distress related to prognostic uncertainty | 5-item scale with questions such as, I am able to cope with the uncertainties about my prognosis, using a 4-point Likert scale of agreement. | 12 weeks | 
| Distress related to prognostic uncertainty | 5-item scale with questions such as, I am able to cope with the uncertainties about my prognosis, using a 4-point Likert scale of agreement. | 20 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, 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
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, ROS1 Positive Non-Small Cell Lung Cancer, Palliative care, survivorship