Rebecca Shelby, PhD, and Gretchen Kimmick, MD, MS, of Duke Cancer Institute recently launched a clinical trial — I HEAL — the findings of which could lead to significant improvements in clinical care and beneficial outcomes for breast cancer survivors with diabetes.
The trial is evaluating the efficacy of a novel intervention they’ve designed to help breast cancer survivors with Type 2 diabetes better manage their diabetes.
An estimated 20 percent of the 3.1 million breast cancer survivors in the U.S. also have Type 2 diabetes. Shelby, the trial's principal investigator and director of education and training for the Duke Cancer Patient Support Program, calls this a “public health crisis.” These patients, she said, are at high risk for cancer recurrence, serious health complications, and premature death. In addition, they experience more severe, disabling symptoms and psychological distress than breast cancer survivors without diabetes.
“Many breast cancer survivors have a hard time managing their diabetes after cancer,” said Shelby. “We believe that this is because side effects from cancer treatment make it even harder to stay engaged. For many of these women, they either become diabetic after cancer, their diabetes becomes more severe, or they develop diabetes as a result of chemotherapy medications. All of these factors contribute to women having a harder time managing their diabetes post-cancer.”
Kimmick, the physician leader of I HEAL — which stands for “Improving Health Engagement and Lifestyle Management for Breast Cancer Survivors with Diabetes” — noted that “not feeling well and high stress levels may even prevent patients from taking care of their diabetes at all.”
She stressed the importance of diabetes self-management strategies include keeping physically active, following a healthy diet, taking medication as directed and consistently monitoring blood sugar levels.
The I HEAL intervention was fully funded by a Research Scholar’s Grant from the local chapter of the American Cancer Society, which awarded DCI researchers and clinicians more than $1.4 million total in breast cancer research grants and scholarships in fiscal year 2016-17. I HEAL was the largest individual grant.
Shelby and Kimmick began developing the intervention in 2011. The trial is now open and actively recruiting. Two hundred and thirty breast cancer survivors with type 2 diabetes will be recruited through the Duke Cancer Institute and Duke Cancer Network. Participants are diverse in age range and previous experience with diabetes.
Participants will be randomized into two groups: the I HEAL diabetes coping skills training intervention and diabetes education or diabetes education alone. Physical symptoms, psychological distress, diabetes self-management behaviors, and self-efficacy will be assessed at baseline, at three months, six months and 12 months. Physical activity will be assessed using wireless activity trackers and data will be obtained from home blood sugar monitoring devices. The study will conclude in April of 2021.
If I HEAL finds that the study intervention improves the well-being of post treatment breast cancer survivors with type 2 diabetes, research will continue on a wider scale, said Kimmick.
“A broader study would aim to measure I HEAL’s success among a diverse range of populations,” she said. “The study team would then hope to educate an expanded array of providers on the intervention materials and ultimately reach more patients. We hope that better diabetes control will lead to less breast cancer recurrences and better survival.”