Recruiting

Palliative CarePatient-centered, Optimal Integration of Survivorship and Palliative Care

Sponsor:

Massachusetts General Hospital

Code:

NCT04900935

Conditions

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

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

POISE

Study Details

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.

Conditions

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

Study ID

NCT04900935

Start date

Sep 29, 2023

Status verified date

Nov, 2025

Completion date

Sep 1, 2027

Anticipated

Primary completion date

Jun 1, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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

no intervention: Usual care

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

Interventions

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.

Primary outcome measure

Feasibility of POISE - enrollment [ Time Frame: 20 weeks ]
Feasibility of POISE - completion of all sessions among patients in intervention group [ Time Frame: 20 weeks ]
Feasibility of POISE - completion of surveys in both arms [ Time Frame: 20 weeks ]

Central Contacts and Locations

Central contacts

Laura A Petrillo, MD

(617) 724-4000 lpetrillo2@mgh.harvard.edu

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Laura A. Petrillo, MD

617-724-4000 lpetrillo2@mgh.harvard.edu

Principal Investigator:

Laura A. Petrillo, MD

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Nov 24, 2025

Last verified

Nov, 2025

Keywords

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
RET Fusion positive Non-Small Cell Lung Cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2025-11-24.