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Talking to Patients and Clinical Trials

September 4, 2012 | AONN+ Blog | Clinical Trials
Featuring:
Lillie D. Shockney, RN, BS, MAS, HON-ONN-CG
Lillie D. Shockney, RN, BS, MAS, HON-ONN-CG
Editor-in-Chief, JONS; Co-Founder, AONN+; University Distinguished Service Professor of Breast Cancer, Administrative Director, The Johns Hopkins Breast Center; Director, Johns Hopkins Cancer Survivorship Programs; Professor of Surgery and Oncology, JHU School of Medicine; Co-Creator, Work Stride-Managing Cancer at Work

Not only are nurse navigators educating and supporting their patients about their upcoming cancer treatment; they are also becoming involved in clinical trial screening and education. (By the way, this is a great way to get part of your salary covered through clinical trial grants). How information is presented regarding clinical trials can directly influence whether a patient asked for more information and eventually signs on or passes on the opportunity to participate. Below are some points to consider when discussing clinical trial opportunities with patients:

  1. Assure the patient that whether they participate or not they will receive quality of care and be treated with dignity, respect and compassion.
  2. The research study will not involve the patient taking a placebo instead of what is already the standard of care. So if it is a 2 arm study with one of the drugs being a placebo the other drugs in the regimen are already what has been established to be the standard of care. The other arm of the study is to determine if a new drug or dosage of a drug is better than standard of care.
  3. Explain in layman’s terms the purpose for the trial. What is it trying to determine that can benefit patients in the future? Provide examples of previous trials (like sentinel node biopsy) that have been done in the past that have resulted in an improvement in standards of care that this patient is benefitting from now.
  4. Explain if this specific patient will personally reap benefit from the trial or if it is the type of trial that will provide information for only future patients. (Many patients will opt to still do the trial if they see that it may benefit the next generation—their children and grandchildren.)
  5. Discuss what the responsibilities will be of the patient in order to participate in the trial—traveling to the cancer center X # of times for example in addition to their regular appointments. Taking a medication and adhering to the schedule meticulously.
  6. Discuss also if the clinical trial involves unpleasant things—blood draws, MRI, etc.
  7. Provide information regarding how the patient will be compensated for their time and expense (ie, parking coupons, even cash in some cases).
  8. Walk the patient through the written documentation about the trial because it can be very overwhelming to the point that such language can be intimidating making a patient less likely to want to participate. (ie, what does protocol mean double blind study, randomization, etc)
  9. In some cases you may be able to offer to a patient the opportunity to talk to a previous patient who participated in the same study.

Part of your navigator role too is to serve as a patient advocate. If you find while you are initially talking with your patient that he/she is really stressed and not able to focus, then this is not the time to embark on a clinical trials discussion. However don’t let the patient lose this opportunity however to consider participating. Instead confirm that the patient meets the criteria for participation and provide to the research nurse information about the patient for contact in a few days. It has been demonstrated that face to face clinical trial recruitment is far more effective and successful than doing it by phone. So if the patient is scheduled to return to the cancer center in a few days for other appointments or tests this may be a more appropriate time to have the research nurse meet her and talk about the trial for which he/she is a candidate.

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