Patient-centered, Optimal Integration of Survivorship and Palliative Care

Not Applicable

Recruiting

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

• Registration Number: NCT04900935
• Lead Sponsor: Massachusetts General Hospital

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 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 Timeline

• Study First Submitted: 2021-05-20
• Study First Submitted QC: 2021-05-20
• Study First Posted: 2021-05-25
• Study Start: 2023-09-29
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-15
• Last Update Posted: 2024-11-19
• Primary Completion: 2027-06-01
• Study Completion: 2027-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
POISE	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

Primary Outcome Measures

Name	Time	Method
Feasibility of POISE	20 Weeks	At least 60% enrollment among eligible patients and 75% completion of all four sessions among patients in the POISE group

Secondary Outcome Measures

Name	Time	Method
Distress related to prognostic uncertainty	20 weeks	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.
Acceptability	20 Weeks	\>70% of patients reporting that they agree or strongly agree with the four measures of satisfaction and comfort with the intervention
Self efficacy	20 weeks	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
Documentation of Goals and Values	20 weeks	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.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States