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Clinical Trials/NCT04900935
NCT04900935
Recruiting
Not Applicable

Patient-centered, Optimal Integration of Survivorship and Palliative Care

Massachusetts General Hospital1 site in 1 country70 target enrollmentSeptember 29, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stage IV Non-small Cell Lung Cancer
Sponsor
Massachusetts General Hospital
Enrollment
70
Locations
1
Primary Endpoint
Feasibility of POISE - enrollment
Status
Recruiting
Last Updated
5 months ago

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 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.

Registry
clinicaltrials.gov
Start Date
September 29, 2023
End Date
September 1, 2027
Last Updated
5 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Laura Petrillo, M.D.

Principal Investigator

Massachusetts General Hospital

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

Outcomes

Primary Outcomes

Feasibility of POISE - enrollment

Time Frame: 20 weeks

≥60% enrollment among eligible patientsamong patients in the POISE group

Feasibility of POISE - completion of all sessions among patients in intervention group

Time Frame: 20 weeks

≥70% completion of all sessions in the intervention arm

Feasibility of POISE - completion of surveys in both arms

Time Frame: 20 weeks

≥70% completion of all surveys in both arms

Secondary Outcomes

  • Acceptability(20 Weeks)
  • Emotional coping with prognosis and prognostic awareness(20 weeks)
  • Self efficacy(20 weeks)
  • Documentation of Goals and Values(20 weeks)

Study Sites (1)

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