Stage IV Non-small Cell Lung CancerNCT04900935
Patient-centered, Optimal Integration of Survivorship and Palliative Care
A study testing POISE in people with Stage IV Non-small Cell Lung Cancer and Targeted Therapy, run by Massachusetts General Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage IV Non-small Cell Lung Cancer, Targeted Therapy, Nonsmall Cell Lung Cancer
- What is being tested?
- POISE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Sep 2023to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Cognitive impairment or serious mental illness that limits ability to provide informed consent
- Need for urgent palliative care or hospice referral
- Pregnant women
- Prisoners
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02115
Laura A. Petrillo, MD, 617-724-4000, lpetrillo2@mgh.harvard.edu
Laura A. Petrillo, MD
About this study
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.
Read the 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.
- Conditions
- Stage IV Non-small Cell Lung Cancer, Targeted Therapy, Nonsmall Cell Lung Cancer, Carcinoma, Non-Small-Cell Lung, ALK-positive Non-small Cell Lung Cancer, EGFR Positive Non-small Cell Lung Cancer
- Being tested
- POISE
- Keywords
- Stage IV Non-small Cell Lung Cancer, Targeted Therapy, Nonsmall Cell Lung Cancer, Carcinoma, Non-Small-Cell Lung, ALK-positive Non-small Cell Lung Cancer, EGFR Positive Non-small Cell Lung Cancer, ROS1 Positive Non-Small Cell Lung Cancer, Palliative care, survivorship, RET Fusion positive Non-Small Cell Lung Cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POISEBehavioural
Also called palliative care intervention
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 group | Role | What they receive |
|---|---|---|
| POISE | Experimental | 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 Receives: Behavioral: POISE |
| Usual care | No intervention | Patients randomized to usual care will receive usual oncology care. They may access standard palliative care as clinically indicated. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of POISE - enrollment
≥60% enrollment among eligible patientsamong patients in the POISE group
Measured: 20 weeks
Feasibility of POISE - completion of all sessions among patients in intervention group
≥70% completion of all sessions in the intervention arm
Measured: 20 weeks
Feasibility of POISE - completion of surveys in both arms
≥70% completion of all surveys in both arms
Measured: 20 weeks
Secondary outcomes (6)
Acceptability
4-item measure of satisfaction and comfort with the intervention
Measured: 20 Weeks
Emotional coping with prognosis and prognostic awareness
Subscale of Prognostic Awareness Impact Scale
Measured: 12 weeks
Emotional coping with prognosis and prognostic awareness
Subscale of Prognostic Awareness Impact Scale
Measured: 20 weeks
Self efficacy
Self-Efficacy of Management of Chronic Disease 6-Item Scale asks patients to rate their confidence in managing symptoms and activities related to chronic disease on a 1-10 scale, ranging from 1 (not at all confident) to 10 (totally confident).
Measured: 12 weeks
Self efficacy
Self-Efficacy of Management of Chronic Disease 6-Item Scale asks patients to rate their confidence in managing symptoms and activities related to chronic disease on a 1-10 scale
Measured: 20 weeks
Documentation of Goals and Values
The investigators will apply a previously developed natural language processing/machine learning (ML) algorithm to palliative care and oncology notes from the study period in order to identify goals of care conversations using an inductive supervised ML classifier. Notes with a predicted probability of greater than 0.5 will be classified as containing goals of care documentation.
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2021
- Study start29 Sep 2023
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stage IV Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There will be two phases of this research study: 1) an open pilot of 10 patients to refine the intervention and study protocol, in which all patients receive the POISE intervention; followed by 2) a randomized controlled trial in which patients are randomized to receive either the POISE intervention or usual care.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Laura Petrillo, M.D., Massachusetts General Hospital
- Investigators
- Laura A Petrillo, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04900935
- Sponsor's protocol ID
- 20-722
- Other IDs
- K08CA263549
- Status last verified
- Nov 2025
- First submitted
- 20 May 2021
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 40812801
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-centered, Optimal Integration of Survivorship and Palliative Care
- ClinicalTrials.gov ID
- NCT04900935
- Acronym / sponsor ID
- 20-722
- Conditions
- Stage IV Non-small Cell Lung Cancer, Targeted Therapy, Nonsmall Cell Lung Cancer, Carcinoma, Non-Small-Cell Lung, ALK-positive Non-small Cell Lung Cancer, EGFR Positive Non-small Cell Lung Cancer
- Keywords
- Stage IV Non-small Cell Lung Cancer, Targeted Therapy, Nonsmall Cell Lung Cancer, Carcinoma, Non-Small-Cell Lung, ALK-positive Non-small Cell Lung Cancer, EGFR Positive Non-small Cell Lung Cancer, ROS1 Positive Non-Small Cell Lung Cancer, Palliative care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 29 Sep 2023 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 25 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- There will be two phases of this research study: 1) an open pilot of 10 patients to refine the intervention and study protocol, in which all patients receive the POISE intervention; followed by 2) a randomized controlled trial in which patients are randomized to receive either the POISE intervention or usual care.
| Arm | Type | Receives |
|---|---|---|
| POISE | Experimental | Behavioral: POISEThe 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 intervention | –Patients randomized to usual care will receive usual oncology care. They may access standard palliative care as clinically indicated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Cognitive impairment or serious mental illness that limits ability to provide informed consent
- Need for urgent palliative care or hospice referral
- Pregnant women
- Prisoners
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| POISEAlso: palliative care interventionPOISE (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. | Behavioural | POISE |
Primary outcome
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
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Background: PubMed 40812801Richard 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.
- Protocol paperLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laura A Petrillo, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing POISE in people with Stage IV Non-small Cell Lung Cancer and Targeted Therapy, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura A Petrillo, MD ((617) 724-4000, lpetrillo2@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of POISE - enrollment (time frame: 20 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04900935, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.