Research trials opening up for Cape patients

If you were suffering from a serious illness, like dementia or breast cancer, and you were offered a chance for an experimental treatment or the chance to help find a cure, would you do it?

That might be your dilemma if you consider participating in a clinical trial. Now, more people on Cape Cod may be offered the option. Cape Cod Healthcare is developing new ways for local patients to participate in clinical trials, both on and off the Cape.

But first, why even consider it?

“Patients are often asking me, ‘What more can we do? Taking what’s currently approved for Alzheimer’s treatment is not enough for my family. I want to be part of the story of a cure,’” said Hyannis Neurologist Sean Horrigan, DO, of Neurologists of Cape Cod. “Most of the patients that want to do clinical trials, they’re really motivated to make their lives more meaningful than just living with the illness.”

Cape patients who want to participate in clinical trials often have had to do it through teaching hospitals in Boston or Providence. That’s still true for Alzheimer’s trials, Dr. Horrigan said. However, things are changing, particularly for oncology patients, according to Elizabeth Sampson, RN, oncology research program manager for Cape Cod Healthcare.

“Our goal as a program is really to increase the number of treatment trials that we can offer to the community here on Cape Cod,” said Sampson, who was hired in March 2022 with the purpose of opening more trials to Cape oncology patients.

Two Basic Types

There are two basic types of trials – observational trials and treatment studies, Dr. Horrigan said. Observational trials might require that patients and their families be monitored for a particular illness, or that they be willing to share the results of routine blood work to track the progress of a disease. Treatment studies offer a chance to receive an experimental drug or treatment.

For now, neurologists are referring patients with dementia for trials at major medical centers off Cape. Oncologists refer patients to Boston institutions and have been providing tissue samples for researchers. But opportunities are expanding locally for oncology patients, according to Sampson and medical oncologist Thomas Openshaw, MD, MS, who is the medical director of the CCHC oncology research program.

Besides the current collaboration with Dana-Farber, the local program now has the ability to open trials from the National Cancer Institute. The program is also participating with pharmaceutical companies and was recently selected as a site for clinical trials for two new breast cancer drugs.

It’s a long process to evaluate a trial and see if it’s appropriate for Cape patients, Dr. Openshaw said.

“The first step is for Elizabeth Sampson and me to take a look at the trial and then, if we think it might be valuable to our community, we forward it to a member of the practice who sees patients with that diagnosis. They look through the protocol and see if it’s treatment that we should make available to them.”

The team then decides whether to make the study available at our cancer center, based on the eligibility requirements of the study and our patients’ needs, he said. For now, they are looking at medical oncology trials but hope to eventually offer radiation oncology trials, as well.

“Probably 2 to 3 percent of patients that we see end up on Dana-Farber studies,” Dr. Openshaw said. “Really our goal is to increase that significantly with the availability of trials locally. It’ll make it much easier for patients.”

Doctors will not suggest a study that is too risky or limits patients’ options, Sampson said. In most cases, a clinical trial is in addition to the usual standard of treatment.

“The doctor who is managing your care will always advise you about the risks and benefits of a treatment trial,” she said.

A patient may decide to not participate or withdraw from a trial due to risks, treatment fatigue or another reason. “This decision will not affect their medical care. They will continue to receive medical treatment for their diagnosis,” Sampson said.

The Steps Involved

The first step in finding out if a clinical trial is appropriate for you is to consult with your doctor. Then, Sampson said, it’s time for some practical thinking about what the study requires based on the answers to questions, such as:

• What are the protocol requirements? Will there be imaging? Bloodwork? Medication? How difficult will it be for the patient to meet the requirements?
• Will this involve more time for infusion therapies, or visits to the doctor or hospital? Does the patient have the energy, resources and patience to stick with the study?
• How long is the study? Some studies may conclude in a few months; others might require participants to be followed for years.
• What are the direct risks and benefits to a participant? Some trials are purely observational, with no clear benefit to the patient, Sampson said.
• Who is the main point of contact and is there a review board or other independent contact? Each oncology study is reviewed by the NCI Investigational Review Board (IRB). For any study opened at Cape Cod Hospital, there is participation by the Cape Cod Hospital IRB, as well. Each study opened at Davenport-Mugar Cancer Center has a physician in charge and will have its own contact person, but the appropriate review board should be mentioned in the consent form, Sampson said. Boards are there to make sure studies are carried out appropriately and that patients are not coerced or exploited.

For the patient, clinical trials are all about calculated risk and motivation, Dr. Horrigan said. “Believe you me, I think just living with [dementia] is heroic and brave in and of itself,” he said. “But I do have some people who will say, ‘I really want to do more, and I want to be part of the story to find a cure.’”