What Patients Should Know About Cancer Research Studies
Before deciding to join a clinical trial, whether for cancer research or for other health conditions, you should learn as much as possible.
We spoke with Cindy Stoner, BS, CCRP, Oncology Clinical Research Manager at Franciscan Health Indianapolis. As an oncology research manager, Stoner often spends time with the patients at physician visits and she stays in communication with patients and family members between office visits. She discusses some of the new changes in cancer research as well as some of the common questions patients and family members had about participating in cancer research studies and clinical trials.
Q: Why Should I Participate In A Clinical Trial?
A: Participating in a clinical trial or study for cancer research helps bring new treatments closer to reaching patients. A trial may help in the understanding of how well a treatment works for a group of patients, offer access to cutting-edge treatment options and provide you access to a medical team that monitors your disease and your overall health.
"Some would argue you get better care in a trial," Stoner said. "You are closely monitored and have a research coordinator following your care in addition to your regular medical team."
"Clinical trials often give a patient hope when they may feel their treatment options are limited," Stoner said.
Q: Are Cancer Clinical Trials Free?
A: No, clinical trials are not free, but the vast majority of the time, it will not be the patient who pays the costs of participating.
"The cost of any investigational drug or procedure is covered by the study sponsor or research site and is not billed to insurance," said Stoner, who has worked in clinical research since 1998. "The cost of routine care is typically covered by Medicare or private insurance so there shouldn't be an increased cost to the patient who participates in a trial."
Q: Can You Leave A Clinical Trial?
A: Yes, if a patient would like to end his or her participation in a research study or clinical trial, they may do so after talking with the research coordinator and the medical team.
"We're never going to suggest something to be done that's not in their best interest just because they are in a trial," Stoner said. "If it's best for them to come off the trial to pursue other treatments, they come off the trial."
Q: Do You Have To Go To An Academic Medical Center To Join A Research Study?
A: Franciscan Health has cancer research teams at Franciscan Health Mooresville, Franciscan Health Indianapolis and Franciscan Health Michigan City Woodland Cancer Center.
Franciscan Health patients have access to national research studies, such as those supported by the National Cancer Institute.
"Franciscan Health has some trials that large academic medical centers may not have," Stoner said. "We select which studies to participate in based on our patient population. Study sponsors will ask us to participate in trials based on our ability to enroll patients and follow regulations, regardless of whether we are an academic center or community hospital "
Q: Should Cancer Patients Be Concerned About Privacy In Research Studies?
A: "We hear some concerns about privacy when we talk about the molecular testing that’s done to develop targeted therapies, but we take extra measures to protect your privacy," Stoner said.
In addition to the steps taken to protect your PHI (protected health information) as a patient, the research team removes identifying information that could be traced back to you when sharing information with the study sponsors.
"Patients and family members have been concerned about how genetic testing results could affect the patient or their family members' ability to find employment or health insurance if a gene change linked to cancer or other inherited disease is discovered," Stoner said. "There are protections in place such as the Genetic Information NonDiscrimination Act to protect individuals from genetic discrimination."
Q: Are Clinical Trials A Last Resort?
A: Clinical trials can take place at any stage of cancer, from stage 1 through stage 4, and have different objectives. Some trials are observational, and only involve data collection," Stoner said. "This helps contribute to the general knowledge about the disease and its prevalence."
Other trials may look at new treatment options or new ways to use existing treatments. Patients are asked to sign an informed consent document before enrolling in a trial. This consent is required to explain the purpose of the trial, foreseeable risks, and any expected benefits. If a patient has questions about the purpose of the study or their other options for treatment, they should discuss those concerns with their physician.
Q: How Has Cancer Research Changed?
A: "Cancer research has become a lot more patient-specific. We now talk about precision medicine and therapy tailored to an individual," Stoner said. "We can look at a group of patients who respond to a treatment or don't respond to find what they have in common. This helps us make better treatment recommendations for patients in the future."
Q: What Should Family Members Know About Research Studies?
"Don't be afraid to ask questions, discuss with your family, and bring questions back to the doctor and research team," Stoner said. "You should make informed choices."
Learn more about research studies available through Franciscan Health at FranciscanHealth.org/research.