Improving Patient and Caregiver Understanding of Risks and Benefits of Immunotherapy for Advanced… (NCT04670445) | Clinical Trial Compass
UnknownNot Applicable
Improving Patient and Caregiver Understanding of Risks and Benefits of Immunotherapy for Advanced Cancer
United States210 participantsStarted 2021-01-23
Plain-language summary
The purpose of this study is to refine and pilot test educational material developed to educate and support patients receiving immunotherapy for advanced cancer.
The intervention is an educational video and question prompt list (QPL) to promote communication between patients, caregivers, and the oncology team about the risks and benefits of immunotherapy.
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:
* All participants (Patients and Caregivers)-Table 1
* Age 18 or older
* Ability to read and respond in English
* Patient Inclusion Criteria (in addition to Table 1)
* Receiving care in the MGH Cancer Center
* Diagnosis of advanced (stage IV) melanoma or advanced, incurable lung cancer, including stage IV non-small cell lung cancer (NSCLC), unresectable stage III NSCLC, extensive-stage small cell lung cancer.
* Plan to initiate immunotherapy with an ICI (pembrolizumab, nivolumab, ipilimumab, atezolizumab or combination), per clinician documentation in the electronic health record or study staff communication with clinician
* Caregiver Inclusion Criteria (in addition to Table 1)
* Identified as "a supportive person involved in their cancer care" by a patient enrolled in the study
Exclusion criteria
* Major psychiatric condition or comorbid illness that prohibits participation in the study
* Cognitive impairment that prohibits provision of informed consent or participation in the study
* 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 - enrollment
Timeframe: Day 1
2
Feasibility, defined as completion of study activities
Timeframe: Baseline to 72 hours
3
Change in participant knowledge, using the Immunotherapy Knowledge Assessment
Timeframe: Baseline to 72 hours
4
Change in participant knowledge, using the Immunotherapy Knowledge Assessment