Advocate Health Care and Aurora Health Care cancer clinics in communities across Illinois and Wisconsin have joined a clinical trial that aims to determine the best way to encourage women with early-stage breast cancer to consistently take prescribed hormone therapy medication.
These clinics will be the first in Illinois and Wisconsin to offer patients the option of participating in this trial.
“For women with early-stage breast cancer, taking daily oral endocrine, or hormone, therapy for five to 10 years following primary treatment has become an effective way to reduce the risk of breast cancer recurrence,” said oncologist Sigrun Hallmeyer, MD, Advocate Aurora Research Institute’s principal investigator for the study. “Unfortunately, hormone therapy can commonly cause side effects that lead many women to stop taking the medication.”
Side effects of hormone therapy include hot flashes, night sweats, joint pain and stiffness, gynecological symptoms, fatigue, and sleep disturbances. Despite the well-established anticancer benefits of long-term hormone therapy, about 50% of women do not follow their prescribed treatment regimen and instead end their hormone treatment early.
Research points to toxicity from hormone therapy as the primary driver of women prematurely ending their treatment. Other reasons include patient-doctor interactions and patient beliefs about medication.
To overcome these obstacles to long-term hormone treatment, doctors can prescribe additional treatments, ranging from acupuncture and cognitive behavioral therapy to antidepressants. However, most women are only seen in clinic every three to six months, so their care team may be unaware of any new side effects they may be experiencing or of how well their current side effects are being managed. And patients may be unaware of the ways in which new side effects could be managed.
This clinical trial will compare the standard approach for adherence to long-term hormone therapy – educational materials plus follow-up visits in the cancer clinic every few months – to an approach of education materials plus active symptom monitoring. This monitoring process will involve a questionnaire about symptoms that can either be conducted via phone, sent via text message or emailed weekly for the first six months and then monthly for the next 12 months.
“Toxicity from hormone therapy can lead to a lower quality of life for many women, so it is understandable why some choose to stop taking their medication,” said Melissa Kadar, Director of the Research Institute’s Center of Excellence in Cancer Research. “This clinical trial is hoping to find ways to better support these women during their treatment so that we can keep their cancer at bay.”
The Research Institute is participating in the study through its inclusion in the National Cancer Institute’s (NCI) Community Oncology Research Program (NCORP), which brings cancer clinical trials to people in their own communities instead of only at major research institutions. This clinical trial is being conducted at all 29 of the Research Institute’s NCORP sites in Illinois and Wisconsin.
The clinical trial, known as S2010, or “Monitoring symptoms to help young women take hormone therapy for stage I-III breast cancer, ASPEN Study,” is coordinated by SWOG Cancer Research Network, a cooperative research group that designs and conducts clinical trials under the sponsorship of NCI.
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