Patient-centered, Optimal Integration of Survivorship and Palliative Care

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

NCT04900935

20-722

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

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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.