New Patient-Centric Breast Cancer Trials : The Ottawa Hospital

"These conversations are happening all the time and physicians need to be increasingly aware that this diversity in treatment choices is being questioned by patients."
"Patients have been amazing at embracing the REaCT [Rethinking Clinical Trials] program."
"Cancer is now the biggest single cause of death in Canada. We really need to implement practical changes to help patients."
"Patients are seeing change happen in real time, as opposed to 20 to 30 years from now."
 Dr. Mark Clemons, breast cancer specialist, Ottawa Hospital

"The ideal would be to identify ten major sites in Canada to join us with at least half of their medical oncologists and general surgeons and oncology specialists on board."
"We would be revolutionizing cancer care worldwide."
Dr. Dean Fergusson, clinical trial expert, Ottawa Hospital

"Other women and other people have participated in trials that have led to the treatments that I am undergoing now, so it is the least I can do to pay it forward and do it for other women who will be undergoing treatments a few years from now."
Yasemin Heinbecker, 44, breast cancer patient, Ottawa, Ontario

Cancer patient Yasemin Heinbecker the Ottawa General Hospital Cancer Centre in Ottawa Tuesday January 31, 2017. TONY CALDWELL / POSTMEDIA NETWORK

A fairly new program has been initiated at the Ottawa Hospital, reflecting a thoughtful research initiative of three Ottawa scientists, all of whom are professors at the University of Ottawa, and also working out of the Ottawa Hospital. There is Dr. Mark Clemons, breast cancer specialist, Dr. Dean Fergusson, clinical trial expert, and Dr. John Hilton, oncologist. They put their experience and their expertise together to come up with a new concept, a program they have named REaCT (Rethinking Clinical Trials).

The program is another portal to arrive at a greater understanding of the various options for treatment offered to breast cancer patients. But it also includes patients themselves to take part in the planning of which treatment to select, through the subsequent personal assessment of what had worked most effectively. It is the patients who undergo treatment options, who are best placed to offer their subjective opinion to clarify their perspective for consideration by medical teams to consider.

The program is set up to encourage and take on board patients for a cooperative effort at streamlining treatments best suited for individual and collective acceptance. The data gleaned is used to determine which of the treatment options turns out to be the most effective. At the same time the study asks patients to state their priorities related to the various treatments. As an example, some patients stated their willingness to put up with toxicity as long as the treatment could be carried on outside of a hospital setting.

There was a recognition by medical staff and researchers that the traditional form of clinical trials had become too complex, leaving a mere three percent of cancer patients willing to participate in them. The REaCT program, in the several years it has been actively running, has succeeded in enrolling a greater number of breast cancer patients in clinical trials than all the other trials taking place in Canada combined.

As an example of its acceptance rate, 90 percent of patients invited to participate agree that they will. Breast cancer patients represent the largest cohort for whom chemotherapy is provided. They are also recognized as becoming increasingly well informed with respect to various treatments, sharing experiences in waiting rooms, at doctors' offices and on social media. Their familiarity has led them to a good understanding of how widely treatments vary, taking into account different hospitals, locations and physicians.

One trial, the one where Yasemin Heinbecker has agreed to volunteer herself, examines the varying numbers of injections prescribed for breast cancer patients in an effort to increase the function of their immune system upon beginning chemotherapy. A drug, Filgrastim, is self-injected from the day following chemotherapy onward. The drug's purpose is to prevent infections, through increasing white blood cell counts.

Filgrastim is injected by patients daily, into the abdomen. The procedure can feel painful, its side effects simulating flu symptoms, found to be extremely unpleasant. Its cost, $200 for each injection, rests with the patient, or is paid for through private insurance. The province, through Cancer Care Ontario, pays for the drug when used by patients over the age of 65. Dependent on how much is prescribed, the treatment can end up costing $12,000.

The pharmaceutical company recommends ten daily injections on beginning chemotherapy. Some doctors follow that regimen, while others prescribe seven, some five injections daily. The randomized REaCT trial follows 200 patients using the drug for various lengths of time for the purpose of studying its effectiveness for the end result of determining an optimum number of injections. The end game will be standardization of the treatment protocol.

The inter-professional team working in the Centre consists of radiologists, breast imaging technologists, surgeons, nurses, medical oncologists, family physicians, social workers, and clerical staff. Photo: The Ottawa Hospital Breast Health Centre