Susan McPeak-Sirois, a former cancer patient who co-chairs the Quebec Breast Cancer Foundation’s 20th anniversary fundraising campaign, said in a Montreal Gazette article:
"It's well known that patients in clinical research trials do better than those who aren't."
It made me wonder: What in her experience led to this belief? Do cancer patients who enroll in clinical trials do better than those who don't?
I have read a lot of marketing material for clinical trials and cancer research, but I'd never seen 'better care' listed as one of the benefits of joining a trial. Of course any health care team would provide the same level of care for all their patients, regardless of whether they join a trial, would they not? I am sure that Research Ethics Boards would not approve any patient information that would suggest that by participating in a clinical trial a patient would get better care.
So what would make someone think they would ‘do better’ in a clinical trial?
I had my a-ha moment during a patient's presentation at the Cancer Quality Council of Ontario meeting. The patient spoke about how frustrating it is to wait by the phone to receive calls for test appointments. In his experience, the biggest challenge in getting cancer treatment was time management. His idea of an ideal patient-centered care approach would be to have a ‘specific time frame for treatment…so we could actually plan our lives’. In other words, if you are going to have a cancer journey, why not start out with a good map? I believe that a clinical trial provides that map.
The benefits of a clinical trial
A surveyof patients who completed clinical trials reported that the large majority - 89% - would consider participating in another clinical trial. Why was this percentage so high? Having to stick around after chemotherapy to provide multiple blood samples can't be enjoyable. Additional tumor biopsies are not fun. Going to the center for more visits and to fill out multiple questionnaires does not fit well into a good work/life balance. What positive experiences of a clinical trial would make a patient want to participate again?
If you do a literature search asking 'Do you get better care on a clinical trial?’ there are several academic articles that pop up. Some might suggest that clinical trial patients have better survival outcomes, but there is no definitive answer in any of these articles, However there is one common theme. No study that I've seen says that clinical trial patients do worse. One study’s conclusion even recommended patients to insist on treatment as part of a protocol.
When putting all these ideas together, I started to connect the dots. The difference is two things: structure, and personal touch.
As referenced in the Quality Council presentation, patients want structure in their treatment. Where do clinical trial patients find this structure? In the consent document. The document may be a long read, but it spells out the expected length of time for participation, a description of all the procedures that will be completed, possible side effects, and more.
The clinical trial also follows a protocol, which is like a recipe for the health-care team. The protocol describes, in detail, the plan for conducting the clinical study and how to carry it out. Any deviations from treatments, tests, scans, visits, or timing in the protocol must be well-documented and in some cases reported to an Ethics Board or other oversight groups. No one likes to do extra paperwork, so someone must be making sure all the treatment, tests, and scans are being done, and done on time.
The personal touch comes from the clinical research coordinator (CRC). It has been said that the CRC is the heart and soul of the research study and plays a significant role in the success. This is the person who makes sure all the tests, and scans are being done on time. In most clinical trials, patients spend more time with their CRC than their doctor. Even after patients complete their participation in treatment part of the clinical trial, the CRC will continue to follow up with the patient to monitor their progress.
As for all the extra tests, scans, and questionnaires that a clinical trial participant has to complete, is there a benefit to the patient? I think so. Who would not welcome all the extra requirements if it meant being more closely monitored, and knowing as soon as possible if there is a change in their disease or how their treatment is working?
How to find a clinical trial
Is a clinical trial perceived as better care? Maybe, but sometimes perception is reality. If 89% of clinical trial patients want to participate in another clinical trial, I think it's more than just for altruistic purposes.
Am I biased because I am part of a clinical research team? Yes! However, I have seen the difference and I believe clinical trials provide what many patients are looking for in their treatment. For some people, the structure and additional personal touch of a clinical trial is considered better care.
Ultimately, it is up to each patient to decide whether participating in a clinical trial is right for them. If the ‘better care’ is perceived or real, it is worth considering a clinical trial.
There are many ways to find clinical trial information, but I recommend http://itstartswithme.ca in Canada and the National Cancer Institute website in the U.S. You can also talk to your doctors: ask them if any clinical trials would be appropriate for you.