Patient-centered, Optimal Integration of Survivorship and Palliative Care
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: POISE.
- Who it may be relevant to
- Registry conditions: Stage IV Non-small Cell Lung Cancer, Targeted Therapy, Nonsmall Cell Lung Cancer, Carcinoma, Non-Small-Cell Lung. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Behavioral POISE
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.
Primary outcome measures
- Feasibility of POISE - enrollment [Time frame: 20 weeks]
- Feasibility of POISE - completion of all sessions among patients in intervention group [Time frame: 20 weeks]
- Feasibility of POISE - completion of surveys in both arms [Time frame: 20 weeks]
Secondary outcome measures (6)
- Acceptability [Time frame: 20 Weeks]
- Emotional coping with prognosis and prognostic awareness [Time frame: 12 weeks]
- Emotional coping with prognosis and prognostic awareness [Time frame: 20 weeks]
- Self efficacy [Time frame: 12 weeks]
- Self efficacy [Time frame: 20 weeks]
- Documentation of Goals and Values [Time frame: 20 weeks]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Massachusetts General Hospital — Boston
Publications
- Richard HA, Sarathy R, Rabideau DJ, Feldman J, Cartagena L, Patel H, Sequist LV, Park E, Jackson V, Greer JA, Temel JS, Petrillo LA. Blended palliative and survivorship care intervention (POISE) for patients with metastatic oncogene-driven non-small cell lung cancer: study protocol for a pilot randomised controlled trial. BMJ Open. 2025 Aug 13;15(8):e098075. doi: 10.1136/bmjopen-2024-098075. PMID 40812801
Identifiers
NCT: NCT04900935 · 20-722 · K08CA263549