Clinical trials for new targeted ROS1 cancer therapies offer hope, but they can also create a unique set of fears and considerations for patients. In this article, we will explore common fears ROS1ders may have when they consider participating in trials, and the important factors they should weigh before making this critical decision.
Getting into a clinical trial
Most ROS1 patients who are looking to join a clinical trial are doing so because of progression of the disease while taking a known targeted therapy treatment. Taking the time to find and connect with the trial and await results of testing can be extremely stressful.
There are advantages to participating in clinical trials. The new treatment might be more effective and/or less toxic than other options. Expert teams offering the trial typically provide a higher level of care than other clinic settings. Your relationship with the team could bring additional resources and knowledge.
However, before joining a trial, ask questions to make sure you understand what the trial involves. Take time to understand the risks and assess how many risks you are willing to tolerate.
Is my general health good enough for a trial?
Do I meet the eligibility criteria--for instance, is my type of ROS1+ cancer eligible?
What procedures are required?
Does the trial require a fresh tissue biopsy? If so, am I able to provide it?
What do we know about this treatment? Is there any preclinical data available?
Might participating in this trial disqualify me from participating in a different trial later on? (Some trials limit the number or type of treatments you can receive before enrolling).
Is a trial the best treatment option for my particular cancer?
Financial worries
Medical expenses are a significant source of stress for many ROS1 cancer patients. Participating in clinical trials may or may not result in additional costs depending on the trial, the healthcare system and insurance. Patients should clarify the financial aspects with the trial coordinators and their insurance providers.
Waiting to hear from insurance can be one of the most stressful times in the clinical trial process. Even with private insurance or Medicare, patients may need assistance to manage distress, financial hardship, non-medical expenses, employment rights, or mental health of clinical trials. Visit our Managing Financing page to learn more about financial options.
Time, commitment and travel
Clinical trials require a substantial time commitment for patients. Frequent clinic visits, tests, and potential travel may disrupt daily life and routines. Patients must assess whether they can manage these commitments while still maintaining their quality of life.
Many clinical trial centers are located in specialized research institutions or medical centers considerable distances from your homes. The travel required can be particularly challenging for individuals who are already dealing with the physical and emotional strains of acquired resistance.
Some clinical trials offer financial support or help coordinate travel arrangements, and it's crucial to inquire about these options during the trial enrollment process.
Unknown side effects
Concerns about safety are common. Patients may worry about potential side effects and long-term health consequences.
When assessing your clinical options, differences between trial phases become important. Phase 1 trials involve more risk than Phase 2 trials because the safety of the drug has not yet been established. Phase 2 trials involve more risk than Phase 3 trials because the side effects and efficacy of the drug have not been established in a large group of people.
However, some patients have found a Phase 1 trial for a targeted therapy may still be more tolerable and/or effective treatment than the standard of care for progression (such as long-term chemotherapy), especially if the study drug has already completed Phase 1 or Phase 2 trials in another country.
Choosing to participate in a study is an important personal decision. Talk with your doctor, family members, or friends who might help support your participation and cancer patients who have participated in trials before deciding to join. The ROS1ders’ Facebook community can also connect you to patients who have gone through the experience and can empathize. If your doctor is not familiar with ROS1+ cancer treatments and clinical trials, it might be wise for your doctor (or you) to consult a ROS1 Clinician-Researcher. You can also talk to other ROS1ders in our private Facebook group--many of us have participated in clinical trials.