Actively Recruiting
Led by Massachusetts General Hospital · Updated on 2025-11-24
70
Participants Needed
1
Research Sites
13 weeks
Total Duration
M
Massachusetts General Hospital
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
Researchers are evaluating a supportive care model called POISE for patients with metastatic Non-small Cell Lung Cancer (NSCLC) who have oncogenic driver mutations and are receiving targeted therapy. This study aims to see if POISE is feasible to deliver, acceptable to patients, and how it affects patients' distress about their uncertain future, confidence in managing cancer, and understanding of what to expect. The POISE intervention includes four 60-minute sessions with specially trained palliative care clinicians who address psychosocial issues and promote health behaviors. Participants in the randomized controlled trial will either receive POISE or continue with usual oncology care, which may include standard palliative care if needed. The study involves an open pilot phase with 10 patients followed by a randomized phase with 60 patients. Participants will complete three surveys at baseline, 12 weeks, and 20 weeks after enrollment, and undergo chart reviews and an exit interview. Researchers will measure feasibility by enrollment rates and session and survey completions, along with acceptability, emotional coping, prognostic awareness, self-efficacy, and documentation of goals and values over 12 to 20 weeks. The total participation period is about 20 weeks.
CONDITIONS
Patient-centered, Optimal Integration of Survivorship and Palliative Care
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote) for eligibility assessment
Duration - Approximately 12 weeks
Participants receive four 60-minute sessions with a trained palliative care clinician to address psychosocial issues and health-promoting behaviors related to metastatic NSCLC.
4 visits with a palliative care clinician
Duration - Up to 20 weeks post-enrollment
Participants complete questionnaires at baseline, 12 weeks, and 20 weeks post-enrollment, and participate in a semi-structured exit interview. Chart reviews are also conducted.
3 questionnaire timepoints and 1 exit interview
Total: 1 location
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
L
Laura A Petrillo, MD
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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Heather A Richard, Roshni Sarathy, Dustin J Rabideau...
https://pubmed.ncbi.nlm.nih.gov/40812801