Patient-centered, Optimal Integration of Survivorship and Palliative Care (NCT04900935) | Clinical Trial Compass
RecruitingNot Applicable
Patient-centered, Optimal Integration of Survivorship and Palliative Care
United States70 participantsStarted 2023-09-29
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility of POISE - enrollment
Timeframe: 20 weeks
2
Feasibility of POISE - completion of all sessions among patients in intervention group
Timeframe: 20 weeks
3
Feasibility of POISE - completion of surveys in both arms