Posts Tagged ‘emory clinical trials’

Cancer Clinical Study Leads to Video Tool for Prostate Cancer Patients

At Emory, research plays a key role in the mission to serve our patients and their families. Medical advances and improvements to patient care have been made possible by research and volunteer participation in clinical trials. More than 1,000 clinical trials are offered at Emory, making a difference in people’s lives, today.

Recently, a clinical study initiated by Winship Cancer Institute of Emory University, found that providing prostate cancer patients with a video-based education tool significantly improved their understanding of key terms necessary to making decisions about their treatment.

The breakthrough study was led by three Winship at Emory investigators; Viraj Master, MD, PhD, FACS; Ashesh Jani, MD; and Michael Goodman, MD, MPH; and is the feature cover story of this month’s Cancer, the peer-reviewed journal of the American Cancer Society.

In 2013, Master, Jani and Goodman released an Emory study that showed that prostate cancer patients (treated at Grady Hospital in Atlanta) experienced a severe lack of understanding of prostate key terms. The original study showed only 15 percent of the patients understood the meaning of “incontinence”; less than a third understood “urinary function” and “bowel habits”; and fewer than 50 percent understood the word “impotence.”

In response to their findings, the three principle investigators jumped to find a solution to the problem. The latest study explored using a video-based tool to educate prostate cancer patients on key terminology. The physicians predicted that with a better understanding of terms linked to disease, patients would be able to participate in shared and informed decision-making throughout the prostate cancer treatment process.

About the Prostate Cancer Video Trial:

  • 56 male patients were recruited from two low-income safety net clinics and received a key term comprehension test before and after viewing the educational video.
  • The video software (viewed by participants on iPads) featured narrated animations depicting 26 terms that doctors and medical staff frequently use in talking with prostate cancer patients.
  • Learn more by watching this video:

clinical trials for prostate cancer

Results of the Prostate Cancer Video Trial:

Participants who viewed the educational video demonstrated statistically significant improvements in comprehension of prostate terminology. For instance, before viewing the application, 14 percent of the men understood “incontinence”; afterward, 50 percent of them demonstrated understanding of the term.

“This shows that video tools can help patients understand these critical prostate health terms in a meaningful way. The ultimate goal is to give patients a vocabulary toolkit to further enable them to make shared and informed decisions about their treatment options,” says Viraj Master. “Our next goal is to improve the tool further, and study this tool at different centers.”

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Additional Information about the Prostate Cancer Trial:

The research for this study was made possible by a Winship Cancer Institute multi-investigator pilot grant and the contributions of faculty and students from Winship, the Rollins School of Public Health and the Emory School of Medicine.

This study was led by three Winship at Emory investigators: Viraj Master, MD, PhD, FACS, Winship urologist and director of clinical research in the Department of Urology at Emory University; Ashesh Jani, MD, professor of radiation oncology in the Emory School of Medicine; and Michael Goodman, MD, MPH, associate professor of epidemiology with the Rollins School of Public Health.

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Clinical Trials Responsible for Advances in Medical Treatment

Tamara Mobley, 38 and married with 8 and 12 year old sons, has been battling multiple myeloma for five years now under the care of Dr. Sagar Lonial at the Winship Cancer Institute of Emory University. She went on a clinical trial at Winship in order to get the most advanced drug for treating this blood cancer. Because of that trial, the drug is now FDA-approved and is helping Tamara maintain her active life.

Clinical trials are responsible for most advances in medical treatment, but they can’t take place without volunteer participants like Tamara. Unfortunately, there are still many misconceptions about clinical trials that keep people from participating.

For instance, some believe joining a clinical trial is a last resort in the treatment process, which was not the case for Tamara and many other Winship patients. For Tamara, enrolling in a clinical trial was a good option once her standard cancer drugs stopped working.

In the video below, Fox 5 Atlanta talked to Tamara and Dr. Lonial about the decision to participate in a clinical trial.

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It is important to speak with your physician about participating in a clinical trial. For more information about a specific trial, please contact the lead research coordinator.

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Phase I Trials – Where All Anticancer Drugs Begin

Donald Harvey, MD

R. Donald Harvey, PharmD, FCCP BCOP, director of the Winship Cancer Institute of Emory University’s Phase I Clinical Trials section

Each of the agents we use to treat cancer had a beginning, a first step, in understanding how safe and effective they might be.  As drugs are developed, we ask questions in different ways at each step, or phase, of testing. The National Cancer Institute reminds us that clinical trials are available for all patients at all points in their cancer journey, not just for patients with advanced cancer that is not responding to treatment.

When a drug is first given to patients, it enters testing in a phase I trial, where we ask questions such as:

  • What is the right dose?
  • How should it be given (e.g., by mouth, by vein, under the skin)?
  • What is the right schedule of treatment?
  • What side effects are there and how severe are they?
  • How often do we see side effects?
  • Where did the drug go in the patient? How well was it absorbed? How was it metabolized and/or eliminated? (Pharmacokinetics)
  • What did the drug do to the patient, both in blood and at the site of the cancer? (Pharmacodynamics)

Patients courageous enough to enter phase I trials are asked to do many time-consuming but important things during the trial. Frequently, patients are asked to spend 10-12 hours in our clinical trials unit and/or come in daily up to 14 times during the first treatment period, or cycle. During these visits, blood is drawn, tumor or bone marrow biopsies may be performed and safety tests are conducted, all in an effort to get a complete picture of drug effect, disposition and side effects.

Participation in phase I clinical trials:

To participate in a phase I trial, patients typically have cancer that has not been effectively treated with other therapies, and most trials require patients to be otherwise relatively healthy. Phase I trials usually enroll 10-40 patients, but may be larger or smaller depending on the questions being asked. Two types of phase I trials exist: those where the drug is being given for the first time, or first-in-human trials; and those where there is prior experience and the drug is given in combination with another drug or drugs (also called phase IB trials). In each, the investigational agent is given to small groups of patients, and doses are increased in each group. Both types are critical to the next step of development to define the dose, frequency, and understand what cancer types are most likely to benefit.

Phase I trials help to determine the future of drugs in cancer treatment. Right now, the large number of new agents in early testing indicates great potential in the transformation of therapy. People in good health may choose to participate in clinical trials simply to help researchers find better treatments. Participation in clinical trials is completely voluntary, but you should also speak with your physician before deciding to enroll.

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About Dr. Harvey

R. Donald Harvey, PharmD, FCCP BCOP is director of the Winship Cancer Institute’s Phase I Clinical Trials section, and Associate Professor of Hematology and Medical Oncology at the Emory University School of Medicine. He is a Fellow of the American College of Clinical Pharmacy and a board certified oncology pharmacist. Widely published in peer-reviewed journals, Dr. Harvey’s research interests include the clinical application of pharmacokinetic, pharmacodynamic, and pharmacogenomic data to patient care.