Patient-centered, Optimal Integration of Survivorship and Palliative Care
2 other identifiers
interventional
70
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 20, 2021
CompletedFirst Posted
Study publicly available on registry
May 25, 2021
CompletedStudy Start
First participant enrolled
September 29, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2027
November 24, 2025
November 1, 2025
3.7 years
May 20, 2021
November 19, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Feasibility of POISE - enrollment
≥60% enrollment among eligible patientsamong patients in the POISE group
20 weeks
Feasibility of POISE - completion of all sessions among patients in intervention group
≥70% completion of all sessions in the intervention arm
20 weeks
Feasibility of POISE - completion of surveys in both arms
≥70% completion of all surveys in both arms
20 weeks
Secondary Outcomes (6)
Acceptability
20 Weeks
Emotional coping with prognosis and prognostic awareness
12 weeks
Emotional coping with prognosis and prognostic awareness
20 weeks
Self efficacy
12 weeks
Self efficacy
20 weeks
- +1 more secondary outcomes
Other Outcomes (8)
Uncertainty tolerance
12 weeks
Uncertainty tolerance
20 weeks
Psychological Distress
12 weeks
- +5 more other outcomes
Study Arms (2)
POISE
EXPERIMENTALThe 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
Usual care
NO INTERVENTIONPatients randomized to usual care will receive usual oncology care. They may access standard palliative care as clinically indicated.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Cognitive impairment or serious mental illness that limits ability to provide informed consent
- Need for urgent palliative care or hospice referral
- Pregnant women
- Prisoners
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Massachusetts General Hospitallead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02115, United States
Related Publications (1)
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: 40812801BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Laura A Petrillo, MD
Massachusetts General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Masking of participants and care providers is not possible in this clinical intervention. However, we will mask the outcomes assessor to minimize bias.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 20, 2021
First Posted
May 25, 2021
Study Start
September 29, 2023
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
September 1, 2027
Last Updated
November 24, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication
- Access Criteria
- Contact the Partners Innovations team at http://www.partners.org/innovation
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.