Helping Patients Find Clinical Trials with ACS ACTS

When Douglas Flora, MD, lost his mother to metastatic breast cancer more than 30 years ago, she was not offered information about clinical trials. They just were not part of her treatment plan.

“My mom never had those options,” he said. "In the 1990s, access to clinical trials in community settings was limited and often discouraged."

Years later, Dr. Flora himself was diagnosed with cancer. Even though more clinical trials were available by then, he wasn’t eligible for them.

“We didn’t have clinical trials available for my cancer stage in my community,” said Dr. Flora, a medical oncologist and executive medical director of the Yung Family Cancer Center at St. Elizabeth Healthcare in Kentucky.

While clinical trials were not in the cards for him or his mother, Dr. Flora dedicates part of his practice to helping patients access trials they might otherwise never know about. An American Cancer Society (ACS) regional board member for Ohio and Kentucky, Dr. Flora helps to promote ACS ACTS™ (Access to Clinical Trials & Support). This program helps patients navigate the clinical trial matching process.

A program designed to remove barriers

Cancer clinical trials are studies of new medicines, procedures, and other treatments that may improve cancer outcomes. These studies are rigorous and required for all cancer treatments before they are approved for use in the U.S. They help scientists and doctors determine if a new treatment is safe and effective. To get the most reliable results, clinical trials should include participants from a wide range of backgrounds.

Clinical trials depend on finding eligible volunteers to participate in the studies. For this to happen, people need to know about a clinical trial, meet the requirements for it, and understand what it means to participate or not participate. But finding enough people to enroll in a study can be hard, often due to:

• Limited access in rural or underserved areas

• Hesitancy to enroll due to mistrust in the medical community or fear of being part of a test or experiment.

• Concern over possibly getting a placebo, even though most clinical trials for cancer do not use placebos unless no standard treatment already exists.

• Lack of awareness of what clinical trials are or that they even exist.

“It’s been a heavy lift,” Dr. Flora said. Patients already dealing with treatment schedules, anxiety, and side effects often lack the time or energy to research trial options, he said.

Also, doctors and researchers face challenges in finding eligible participants. “At my cancer program, a research coordinator could spend an hour screening just one patient’s chart for potential trials. It creates a real bottleneck,” Dr. Flora said.

ACS ACTS was created to ease the burden on patients and health care providers, provide increased access to clinical trials, and offer information on programs and services patients considering a clinical trial may need. The program connects patients, caregivers, and providers with trained ACS cancer information specialists, helping them understand how clinical trials may fit into a treatment journey and explore personalized options.

Through a simple online form, a patient, caregiver, or provider submits basic information, including the type of cancer and support needs they may have. ACS ACTS uses artificial intelligence to analyze the information and provide a list of potential clinical trials.

Throughout the process, ACS ACTS offers resources and free ACS programs, such as Road To Recovery® and Hope Lodge® communities, that help address some of the barriers to participating in clinical trials. The goal is to help ensure that patients have both the opportunity and the support to enroll and stay in a trial.

Expanding equity and addressing mistrust

Participation in cancer clinical trials is lowest among groups that have some of the highest incidence rates. In the U.S., Black people have higher cancer incidence and death rates for several cancers compared to White people. And while Black people make up about 13% of the U.S. population, only about 5% of clinical trial participants are Black.

Dr. Flora said the historical exploitation of Black men and women in medical research has caused mistrust in clinical trials and has contributed to the lack of participation. Others who have higher cancer incidence and death rates are not well represented in trials either, including Native Americans, people who live in rural areas, and older adults.

“If you are Black or Hispanic or if you live in a low-resource area, the enrollment remains very low," he said.

ACS hopes ACTS can boost enrollment among the underserved by improving education and awareness about clinical trials.

For Dr. Flora, ACS ACTS is an opportunity to offer treatment options that were not available to his mother or him. Higher participation in clinical trials can help researchers learn more quickly, which may speed up the development of new treatments.

“I would love to accelerate the enrollments so that these trials can close sooner so that my patients can get access to those drugs sooner,” he said.