Cancer Clinical Research Options for Cancer Survivors

1. Cancer Clinical Research Options for Cancer Survivors Jeannette Mendez, BA, CCRP Cancer Disparities Research Coordinator Mayo Clinic Arizona

2. What is cancer Clinical Research? • Cancer clinical studies are conducted by medical scientists to improve the care and treatment of cancer patients • Cancer clinical studies test new ways to: • Diagnose and treat cancer in people • Prevent or reduce disease or treatment side effects • Prevent or treat a recurrence of cancer • Improve the comfort and quality of life of people with cancer

3. Background • ACS estimated about 30,000 individuals in Arizona received a cancer diagnosis in 2010 • An estimated 20% of all adult cancer patients are medically eligible for a cancer clinical trial • Trial participation in the US remains between 3-5% in the general population and 1% in minority groups.

4. Types of Studies • Screening • Prevention • Treatment • Quality of Life

5. Screening • Test the best way to find cancer, especially in its early stages Genetics Laboratory Imaging

6. Prevention • Test new methods, like medicines, vitamins, minerals, or other supplements that doctors think may lower the risk of a certain type of cancer • Two kinds of prevention clinical studies • Action studies (doing something) • Find out whether actions people take, such as exercising more or quitting smoking, can prevent cancer. • Agent studies (taking something) • Find out whether taking certain medicines, vitamins, minerals or food supplements (or a combination of them) can prevent cancer.

7. Treatment Studies • Test new treatments • new cancer drugs • new ways of doing surgery or radiation therapy • new combinations of treatments • new methods such as gene therapy Are placebos used in cancer treatment clinical trials? Placebos also known as “sugar pills” are rarely used in treatment trials! In fact, it is unethical to not treat a patient during their cancer journey! Patients must minimally receive standard care.

8. Quality of Life • Look at ways to improve comfort and quality of life for cancer patients • Cancer control • Symptom management

9. Phases of a Study • Objective: To establish a drug’s pharmacokinetic profile and safety profile • Protocol is less detailed to allow more design flexibility • Phase I answers: • What is the correct dose? • What are the side effects? • How is the drug metabolized? • Safety/tolerability? • First time in human subjects • Pharmacokinetics / pharmacodynamics • Open label, often single center • Not always performed in the U.S.

10. Case Example #1 • Native American, Female, metastatic breast cancer, Triple Negative, 3 prior chemo regimens, exhausted options at home institution • Would be eligible for studies that allow her indication and can range from phase 1 to 4. • Mayo had 5 options for her at one point excluding phase 1!

11. Case Example #2 • Hispanic, Female, newly diagnosed breast cancer, indicated for masectomy with a mass larger than 2cm. Patient wants other options. • Patient eligible for neo-adjuvant study where she received chemo before surgery, and her tumor shrunk enough for her to have breast conservation surgery saving her from completely removing her breast.

12. Learning about clinical trials • Study Design • Eligibility • Safety • Costs

13. Study Design Each cancer clinical study has a written detailed design, called the protocol, that includes: • background of why the clinical study is needed • the purpose of the study • what drug or drugs are being tested, along with a treatment and follow-up schedule • safety measures to be followed throughout the clinical study program

14. Eligibility • Clinical studies… • are not only for people with the most advanced disease • can also be for people with newly diagnosed or very limited disease • are appropriate for different types of people, depending on the purpose and phase of the study • take into account age, gender, race, stage of disease, other treatments used, and presence of any other illness

15. Safety • Each study is managed according to a strict set of rules intended to protect patients • quality of care • safety of participants • Researchers must explain the purpose, benefits, and risks of a clinical study before a patient gives consent • must be in a language they understand • they can ask questions if anything is unclear • they can have a language interpreter if needed • they may bring an advocate

16. Costs • Costs that are usually covered by the sponsor at no cost to the patient: • research physician and nurse time • cost of the drug being studied • Costs that may not be covered by private or public health insurance are those that a patient would have whether or not he / she was in a clinical trial: • hospitalizations • doctor visits • laboratory tests • drugs that are not part of the study design

17. If trials are successful, What gets in the way? • Cancer patients may not have access to clinical studies • e.g., under-insured or have no insurance, worry about cost Mayo Clinic ADVOCATES-Economic hardship and Pharmacy Assistance Programs • may fear or distrust medical research • I don’t want to be a “guinea pig” Mayo Clinic EDUCATES-The Clinical Trial Process • may face practical obstacles: • Transportation, meals, housing Mayo Clinic provides SUPPORT through an ACS patient navigator.

18. If trials are successful, what gets in the way? • Cancer Patients … • may lack health literacy • may not want to ask their current doctor about studies, or do not want to go against their doctor’s wishes Mayo Clinic provides TRANSLATORS. • may be less likely to participate in clinical studies if • they belong to an ethnic minority, or • they are older / aged Mayo Clinic employs CULTURALLY COMPETENT staff.

19. Critical Barrier in Cancer Clinical Trials • Unaware of the option of participating in clinical trials. Research has consistently shown that most people are not aware that clinical trials could be an option for cancer treatment or prevention. To achieve a balance in health literacy, clinical trial Awareness is vital.

20. A promise for the future If we, as a population understand cancer research trials as a therapy option, then we may extend the life of those we love.

21. Participation in clinical trials: What gets in the way? • Doctors might… • be unaware of available clinical studies • believe that standard therapy is best • be concerned about administrative burdens • be unwilling to “lose control” of a patient’s care • be concerned about how a patient will react tothe suggestion of a clinical study Mayo Clinic educates members of the community on the need for minorities in cancer clinical trials.

22. A Mayo Research Experience • Diagnosis- Patient informed of treatment options. Research always included. • Consent-Patient is informed of study and asked if interested. • Screening- Staff makes sure patient is eligible. This is a safeguard. • Enrollment- Eligible patients enrolled.

23. A Mayo Research Experience Active Treatment- Patient closely monitored by physician and research staff. Completion- Patient completes research therapy Follow Up- Patient is followed through study regulations. #1 priority is the patient’s safety and well being!

24. Research Collaborations Targeting increased minority enrollment in cancer trials, Mayo Clinic currently engages in research with: -Maricopa Integrated Health Systems -Mountain Park Health Center -Phoenix Indian Medical Center -Arizona State University.

25. Minorities in Research • Evidence of genetic variance in responses to cancer drugs! • Lack of minority representation in cancer research causes lack of true efficacy. The solution to end disparity in medicine is to work together. Like the pieces of a jigsaw puzzle, each race’s genetic make-up is unique.

26. Advocating Cancer Trials • Participation in cancer research is key. Clinical Trial Education necessary for this to be achieved. Medicine is the glue that keeps us together and working towards a main goal. By full participation of all, we interlock these jigsaw puzzles and work to advance medicine as a team.

27. Research at your institution…

28. What can we do? • Know your community and it’s resources • Create partnerships and establish relationships • Provide education to the community, its leaders and key stakeholders • Listen to the needs of the community • Be sensitive to the words you use to describe the clinical trials process

29. “The needs of the patient come first”-Mayo Clinic “One must not forget that recovery is brought about not by the physician, but by the sick man himself.  He heals himself, by his own power, exactly as he walks by means of his own power, or eats, or thinks, breathes or sleeps” ~Georg Groddeck

30. Contact Info Jeannette Mendez Cancer Disparities Research Coordinator (480)301-6478 Mendez.jeannette@mayo.edu