Patient-centered, Optimal Integration of Survivorship and Palliative Care

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT04900935
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • POISE — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Sep 29, 2023
Status verified
Nov 2025
Primary completion
Jun 1, 2027
Completion
Sep 1, 2027

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

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.

Primary Outcome Measure

Feasibility of POISE - enrollment [ Time Frame: 20 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02115
Laura A. Petrillo, MD
[email protected]
617-724-4000
Laura A. Petrillo, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Massachusetts General Hospital· Boston, MA

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