What is a supportive care trial?
They’re the kind of studies that focus on things like symptoms and quality of life that may be related to having a cancer diagnosis or to the complications of cancer treatment. A cancer journey can be really complicated, and can have a lot of physical, emotional, and spiritual side effects. So having trials that specifically address those kind of symptoms can help improve and ease someone's trajectory while they're coping with their cancer.
How do supportive care trials differ from other kinds of clinical trials?
There are several ways in which they differ. Not always, but oftentimes, supportive trials may be less specific to a particular cancer diagnosis. They tend to be more inclusive of different kinds of cancers. Often they focus on the more serious cancer diagnoses, because they are associated with more side effects.
Another thing that distinguishes them is that for other kinds of clinical trials, oftentimes they involve a lot of testing and scans, and extensive in-person assessments beforehand. Those are usually minimized in supportive trials. And one of the silver linings of COVID is we've realized that in many supportive care trials, the research activities can be done virtually, so the burden of participating in person often can be minimized.
What are some examples of recent supportive care trials?
Cathy Bradley, who is deputy director of the Cancer Center, just concluded enrollment in a supportive care study focused on caregivers, trying to improve mental health outcomes for people who are helping cancer patients. We know cancer caregivers have a lot of stress and challenges.
We are also one of 20 sites for a very large trial – the Resilience and Equity in Aging, Cancer, and Health (REACH) trial led by the Dana-Farber Cancer Institute – with over 1,000 patients around the country comparing telehealth versus in-person palliative care for patients with advanced lung cancer diagnoses. That study started before the pandemic, then the pandemic happened, and so much clinical care shifted to a telehealth platform during those years. But the trial is persisted, and we’re waiting on results.
I’m leading an ongoing trial of psilocybin-assisted psychotherapy for patients with serious cancer diagnoses to improve anxiety, depression, and existential distress. We're addressing emotional symptoms that can come with having a serious cancer diagnosis. Because this involves an actual drug, we do have some of the more stringent requirements that come along with our more traditional clinical trials at the Cancer Center. That includes blood work and EKGs and testing as part of an early assessment of patients to minimize any kind of serious adverse events. Our trial is being done with full FDA and DEA approval, because we are a federally funded institution.
Are these studies a priority for the CU Cancer Center?
In the CU Cancer Center’s research programs, supportive care is seen as a core component. We know that quality of life, pain, and symptom management can really impact someone's cancer journey. If people are miserable, their time isn’t as meaningful. When we can control symptoms and improve quality of life, people actually live longer.
When we talk to patients, one of the things that I hear over and over again is the importance of quality of life. We can’t just be living longer if we’re not also living better. These studies help us understand how to make that journey better, how to help people have and achieve and maintain that quality of life through a very difficult time.
Supportive care is quite important to cancer prevention and control and to the Cancer Center. It’s also a core component of the Colorado Cancer Plan.
If a patient is interested in participating in a supportive care trial, how do they reach out?
Many of these trials have very specific inclusion and exclusion criteria, but it’s always worthwhile for patients to talk to their oncologist or reach out to our research personnel to see if they might be eligible. We do our best to make sure that all the oncologists, nurses, social workers, and psychologists within the Cancer Center know about our trials. Recruitment is always one of the most challenging aspects of conducting any clinical trial, so we seek out and welcome referrals in all kinds of ways.