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Patient-centered, Optimal Integration of Survivorship and Palliative Care

Mass General Brigham logo

Mass General Brigham

Status

Enrolling

Conditions

EGFR Positive Non-small Cell Lung Cancer
Targeted Therapy
ALK-positive Non-small Cell Lung Cancer
Nonsmall Cell Lung Cancer
Survivorship
Stage IV Non-small Cell Lung Cancer
Carcinoma, Non-Small-Cell Lung
Palliative Care

Treatments

Behavioral: POISE

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

70 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

70 participants in 2 patient groups

POISE
Experimental group
Description:
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
Treatment:
Behavioral: POISE
Usual care
No Intervention group
Description:
Patients randomized to usual care will receive usual oncology care. They may access standard palliative care as clinically indicated.

Trial contacts and locations

1

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Central trial contact

Laura A Petrillo, MD

Data sourced from clinicaltrials.gov

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