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Clinical Trials: Finding Your Passion for Research Shannon Benson, RN, MSN Administrator Iowa-Wide Oncology Research Coalition Who is I-WORC? Iowa Oncology Research Association Funded by the National Cancer Institute Established in 1978 8 Sites: Des Moines, Blank, Mason City, Ames, Cedar Rapids x 2, Ottumwa, Moline Organizational Chart NCI Research Bases Community Sites I-WORC Goal for my 45 Minutes with You My personal excitement for research “The work that we do is important for a number of reasons and therefore, it is important to do good work.” My Goal/Purpose for this talk “In our field, we have a chance to be part of something big.” Dr. John A. Clements, M.D. Recipient of the 2008 Pollin Prize In 1953, Dr. John Clements made a discovery about how the lungs work production of synthetic surfactant lowered the mortality rate of RDS in premature babies from over 90% to under 5% At the age of 92, Dr. Clements still comes to work every day. When asked why, he says there's always the chance that a new day will bring a new scientific insight Research Basics Clinical trials are a critical part of the research process ◦ Today’s most effective treatments are based on previous study results The more people who participate, the faster critical research questions can be answered This will lead to better treatment and prevention options for all cancers In the past, clinical trials were seen as the last resort for patients with no other treatment options Studies we Offer Phase 2: How well the treatment works ◦ Less than 100 people ◦ Determining if the agent has an effect on a particular cancer ◦ How the agent affects the human body ◦ In general, phase 2 participants have been treated previously, but the treatment wasn’t effective Phases Continued Phase 3: Comparing a new treatment to the standard treatment ◦ Anywhere from 100 to 1000’s of people ◦ Purpose: to compare a new agent to the standard ◦ Control group vs. investigational group ◦ Majority of studies at IORA ◦ Ex: Ph III Trial of CHOP versus R-CHOP Why research takes extra work? Physicians ◦ Have to follow a protocol Eligibility criteria, how to treat, dose mods, how often to be seen, tests to order ◦ Loss of control ◦ Scrutiny of audits Nurses ◦ Constant communication with research staff Schedulers How I Encourage Our Staff It’s not enough to just be ◦ Smart ◦ Great at Your job (audits ensure this) They also have to be enthusiastic ◦ Portray/model enthusiasm and hope that it is infectious When they feel like it’s just too much, I remind them of why we do what we do A Couple Exciting Studies MATCH COMET S0820/PACES A011401 MATCH Trial National cutting edge Precision Medicine Trial Explores treating patients based on the molecular profiles of their tumors For adults with solid tumor and lymphomas that no longer respond to standard treatment Biopsied tumor tissue will undergo gene sequencing. Gene sequencing will look for changes in 143 genes. If a patients tumor has a genetic abnormality that matches one targeted by a drug used in the trial, the patient will be eligible to join the treatment portion of the MATCH trial COMET COMET: COMmunication and Education in Tumor Profiling an ancillary study to MATCH Can web-based genetic education address gaps in the delivery of precision medicine? COMET cont. Patients report benefits of tumor profiling, but 71% report potential disadvantages (loss of hope, disappointment, unwanted information) Oncologists report less confidence providing psychosocial support and psychosocial counseling about secondary germline testing for potential inherited incidental findings Patients are randomized to usual care alone or usual Care + Self-Guided Online Genetic Education S0820/PACES A Double Blind Placebo-Controlled Trial of Eflornithine and Sulindac to Prevent Recurrence of High Risk Adenomas and Second Primary Colorectal Cancers in Patients with Stage 0-III Colon or Rectal Cancer Primary Objective: to assess whether eflornithine 500 mg or sulindac 150 mg are effective in reducing the 3-year rate of high risk adenomas or second primary colorectal cancers in stage 0, I, II, and III colon or rectal cancer patients Background Among colorectal adenoma patients treated for 3 years with either placebo/placebo or eflornithine/sulindac, a 70% reduction in total adenomas was observed for the intervention group More importantly for the field of cancer prevention was the effect of eflornithine/sulindac on advanced adenomas and multiple adenomas: where >90% reductions were observed (ie, these are the types of adenomas that are more likely to progress to CRC) A011401 Randomized Phase III Trial Evaluating the Role of Weight Loss In Adjuvant Treatment of Overweight and Obese Women with Early Breast Cancer Indirect evidence that purposeful weight loss could lower risk of recurrence Schema 3136 participants Key Eligibility: •Stage II-III breast cancer •HER-2 •BMI ≥ 27 kg/m2 R A N D O M I Z E 2-year telephone-based weight loss intervention + Health education Health Education Alone Research Matters We KNOW it’s extra work Support the research staff Clinical Trial Resources NCI resources ◦ 1-800-4-CANCER ◦ www.cancer.gov/clinicaltrials NIH ◦ www.clinicaltrials.gov Iowa Oncology Research Association ◦ www.iora.org ◦ 515-241-3305 Perspective Our Team Shannon Benson, RN, MSN Administrator IORA, I-WORC 1221 Pleasant St. Suite 450 Des Moines, IA 50309 [email protected] 515-241-3305 Thank you! For your time and attention Any questions