Clinical Trials and Breast Cancer: Improving Lives with mHealth

By October 27, 2015Blog, Clinical 6

October is Breast Cancer Awareness Month, which is an annual campaign to increase awareness of the disease. While most may already be aware of the disease, many forget to take the necessary steps to have a plan to detect the disease in its early stages and encourage others to do the same.

U.S. Breast Cancer Statistics:

  • In the U.S., 1 in 8 women (about 12%) will develop invasive breast cancer over the course of her lifetime.
  • In 2015, an estimated 231,840 new cases of invasive breast cancer are expected to be diagnosed in women, along with 60,290 new cases of non-invasive breast cancer.
  • 2,350 new cases of invasive breast cancer are expected to be diagnosed in men in 2015. A man’s lifetime risk of breast cancer is about 1 in 1,000.
  • A study in 2002 called the Women’s Health Initiative suggested a connection between hormone replacement therapy (HRT) and increased breast cancer. After the study was published the use of HRT decreased and from 2002 to 2003 alone, the incidence rates of breast cancer in the U.S. dropped by 7%.
  • 40,290 women in the U.S. are expected to die from breast cancer this year.

It is important to understand the symptoms and risks associated with breast cancer. A new lump in the breast or underarm can be a sign of cancer. Symptoms also include thickening or swelling of the breast, irritation or dimpling of breast skin, redness or flaky skin around the nipple, unusual discharge, or pain in any area of the breast. You’re more likely to develop breast cancer with long term use of HRT (hormone replacement therapy), a personal history of breast cancer or non-cancerous breast diseases, family history of breast cancer, radiation exposure to the breast/chest, and heavy drinking. If you or a loved one begin to experience symptoms of breast cancer or feel you may be at a high risk, please visit your doctor.

Over the past 30 years, treatment of breast cancer has greatly improved due to research through clinical trials. The first effective treatment of breast cancer, discovered by William Halsted in 1894, involved a radical mastectomy, in which a surgeon removes the full breast, the surrounding lymph nodes, and chest muscles. Although the approach improved cure rates and resulted in fewer recurrences than previous surgical approaches, it resulted in significant side-effects and cosmetic disfigurement that seriously diminished the quality of life for many women. As time progressed, more effective and less invasive treatments became available. In 1971, a limited mastectomy was proven effective to treat early-stage breast cancer in women. Just three years later, in 1974, the first studies of the chemotherapy drug doxorubicin (Adriamycin) in breast cancer demonstrates that the drug can shrink breast tumors in women with advanced disease. Doxorubicin remains a mainstay of treatment for breast cancer today, often in combination with other drugs (such as cyclophosphamide, paclitaxel, or docetaxel).

If you or a loved one has breast cancer, participating in a clinical trial is encouraged. Trials offer the chance to try new treatments and the potential to help others. Traditionally, participating has been easier said than done. Drawbacks, such as trial location and time constraints, have prevented participation or discouraged people from committing to the study. However, with new innovations with mobile health these issues can be resolved.

One reason people may choose not to participate in a clinical trial is due to inconvenience. For example, traditional trial methods ask participants to travel to a designated study site on multiple occasions and keep records of their day using a paper diary method. Not only does this greatly inconvenience the patient, but also has the potential to report false data. The traditional paper diary method is open to flaw and requires patients to set aside time in their day to log their daily habits and activities.

By adopting mobile technology into the clinical environment, these issues can be resolved. Through the use of mobile tech, a remote clinical trial is possible, meaning patients will no longer be required to travel to a study site on a regular basis. Also, by using an eDiary patients are no longer required to take time out of their day to fill out a paper form. If they need to log their food intake or a strange symptom they experience, this can all be done through their mobile device the moment it occurs. In addition, with the popular rise in wearable technology, some of this information is automatically collected. For example, the most basic Fitbit tracker logs steps, activity level, and sleep patterns. This not only results in a happier patient, but also higher frequency and enhanced quality data.

Another problem facing many clinical trials is patient retention. Study participant dropout rates account for approximately 15-40% of enrolled patients in clinical trials. One of the best ways to keep a patient engaged in a trial is through communication and support. According to Jim Kremidas, Lead Investigator at CenterWatch, communication with patients is an “often-ignored barrier to the success of clinical research.” Participants in clinical trials want to receive regular communication and information of a high quality. Many patients would like to be kept informed throughout a trial and receive a summary of the results after the trial has been completed. However, with the traditional trial design, this may be difficult since patients only see their doctor or physician during their site visits, making questions and communication very sporadic. The solution can be found in mobile technology. Patients are able to chat with their doctor if they have any questions or concerns the moment the thought occurs. The familiarity and universal nature of mobile devices makes the technology the perfect solution to integrate into the clinical research landscape and help physicians and patients communicate more effectively. It is already considered an integral part of everyday life and offers one of the fastest and easiest methods of two-way communication with patients in clinical trials. Indeed, the biggest benefit that mHealth offers overall, is the convenience and compatibility in patients’ lifestyles during the trial.

Parallel 6 has developed the Clinical 6 platform, which is completely changing the way patients and physicians are communicating. All contact can now be done through a single mobile application for quick and easy access to medical care and questions. If you would like to learn more about Clinical 6, please visit our website and request a demo.

The integration of mobile health care and breast cancer trials has the potential to revolutionize the way treatment is carried out. Participants will be able to enjoy their trial experience more and have the opportunity to help others through their contribution. There is still a long road ahead as we continue to lose many women to breast cancer every year. However, with the continuing use and improvements through clinical trials there is hope for patients with breast cancer in the near future. If you would like to learn more about breast cancer in clinical trials please visit the National Breast Cancer Foundation, Inc. website for more information or Susan G. Komen’s webpage on clinical research. If you want to donate to support breast cancer research, you can find a list of organizations here.

About Kamei Triebell