University of Maryland Medical System Participates in ASPEN Study to Improve Hormone Therapy Adherence for Younger Breast Cancer Survivors

Researchers at the University of Maryland Medical System are part of the ASPEN Study, a large, multicenter, phase III trial focused on finding ways to improve medication adherence among premenopausal women on endocrine therapy. 

In most cases of breast cancer (75 to 80 percent), breast tumors are estrogen-receptor positive. In those cases, women benefit from an extended course (most often five to ten years) of adjuvant endocrine therapy to prevent recurrence. It’s especially important for younger (premenopausal) women, who are generally at higher risk for recurrence.

However, despite significant therapeutic benefits, there is a high nonadherence rate. One key reason is that endocrine therapy can come with a host of unpleasant side effects that can interfere with an individual’s desire to continue taking the medicine, preventing regular adherence and persistence with the therapy. Side effects can include vaginal symptoms, mood disturbances, hot flashes, muscle aches, and sleep disruption.

The ASPEN Study's Goal

The ASPEN Study focuses on younger women who have gone through breast cancer treatment – a group that is often underrepresented in clinical trial data. The study’s goal is to understand whether conducting active symptom monitoring between follow-up visits can help identify problematic side effects earlier, so they can be addressed before the patient elects to discontinue endocrine therapy. 

“Sometimes, providers only see patients once every three months when they’re on these long-term medications, and even during a visit, we may not ask questions that would prompt patients to bring up side effects,” said medical oncologist Paula Y. Rosenblatt, MD, who is leading the health system’s participation in this trial. “Active symptom monitoring has the potential to make a big difference. Providers gain an ability to home in on symptoms through this kind of more intensive monitoring, and patients feel more empowered to address bothersome side effects.”

The study compares long-term medication adherence in patients who get patient education only with those who receive patient education plus active symptom monitoring. Patients in the active symptom monitoring group will receive weekly texts, emails, or calls for the first 24 weeks they are on adjuvant endocrine therapy to check in and find out how they’re doing on the medication. These weekly communications will collect patient-reported outcomes and quality of life measures, and any areas of concern are relayed back to the patient’s physician for follow-up care. After the first 24 weeks, the check-in frequency shifts to every four weeks for the next 48 weeks.

“The study’s goal is to see whether the additional support provided in the trial can help patients prioritize their quality of life after cancer treatment, address troublesome side effects before they become severe, and stay on the prescribed treatment,” said Mary Alexandra Cook, MD, medical oncologist at University of Maryland Upper Chesapeake Medical Center. “The weekly check-in prompts self-reflection, giving participants space to think about their quality of life, including intangible effects, both physiological and psychological.”

Nationwide, the ASPEN Study is about halfway through the accrual phase, and researchers expect the trial to be open for about 18 months longer.

A simple solution to a big problem

The ASPEN Study is helping to determine how providers can use technology to more effectively monitor how patients are responding to medications in a deliberate, sustained manner. Even though this trial is not testing a groundbreaking new drug, it has the potential to change the lives of many breast cancer survivors for the better.

“These endocrine therapy drugs are awesome medications – associated with a 40-percent reduction in cancer recurrence – but they only work if you use them,” Dr. Rosenblatt said. To get the most benefit for our patients, we need to identify and address barriers to adherence.”

The ASPEN trial is being offered at UM Greenebaum Comprehensive Cancer Center, the Kaufman Cancer Center at UM Upper Chesapeake Medical Center, the Cancer Institute at UM St. Joseph’s Medical Center, and the Cancer Center at UM Shore Regional Health.

Refer a patient and learn more about breast cancer care at the University of Maryland Medical System.