JEOPARDY! I Can’t Believe It’s Not JEOPARDY!

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What is the purpose of clinical trials? To ask specific scientific questions to find better ways to prevent, detect, or treat diseases or to improve care for people with diseases

JEOPARDY! I Can’t Believe It’s Not JEOPARDY!

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What is the number one reason cancer patients participate in clinical trials? a.The doctor recommended it b. They saw an ad in the newspaper c.They did research on their own/found it on the internet a. The doctor recommended it

RL Comis, D. Colaizzi and J. D. Miller Cancer clinical trials (CCT) awareness and attitudes in cancer of Clinical Oncology, 2006 ASCO Annual Meeting Proceedings Vol 24, No 18S (June 20 Supplement), 2006: 6061

JEOPARDY! I Can’t Believe It’s Not JEOPARDY!

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True or False? Cancer clinical trials are only for people who have no other options left. FALSE There are trials for all kinds of cancers, from the most advanced to the ones found very early.

Fact Clinical trials are not only for those patients with the most advanced disease; many patients get first line treatment through a clinical trial.

At first treatment, in the adjuvant setting, at recurrence… How can we ensure that every patient feels confident to ask, “is there a trial for me?”

JEOPARDY! I Can’t Believe It’s Not JEOPARDY!

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True or False? New approaches being tested in clinical trials are probably more effective than the current or standard treatment. FALSE New methods may or may not be better than current treatment. A Phase 3 study goal is to determine whether there is a difference.

JEOPARDY! I Can’t Believe It’s Not JEOPARDY!

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True or False? The reason clinical trials are done is that no one yet knows if a new treatment… 1.Is safe 2.Is effective 3.Will turn out to be better than the approaches currently being used TRUE These are also the three phases of clinical trials.

There Are 3 Phases of Clinical Trials Phase 1 trials Is it SAFE? Phase 2 trials Does it WORK? Phase 3 trials Is it BETTER than what is used now to treat this cancer?

JEOPARDY! I Can’t Believe It’s Not JEOPARDY!

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True or False? Cancer clinical trials seek to find better types of cancer treatments FALSE There are many types of cancer clinical trials.

Fact: There are Many Types of Clinical Trials Treatment –Even as 1 st line Prevention/ chemoprevention –For primary or secondary cancer Diagnostic Genetics Quality-of-life/ supportive care Screening and early detection

There are different types of cancer clinical trials For people who have cancer –Treatment –Genetics –Quality-of-life/supportive care For people at high risk for getting cancer –Prevention –Genetics For people being screened for cancer Another way to look at it…

JEOPARDY! I Can’t Believe It’s Not JEOPARDY!

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3 percent vs. 70 percent What is the percentage of adult cancer patients participating in cancer clinical trials vs. pediatric cancer patients?

More children 0-14 surviving cancer due to CCTs

Very Few People Participate Less than 3% of all cancer patients receive treatment through a clinical trial (20% eligible) –Participation rate is even lower among people of color, older people, and the medically underserved who tend to have higher cancer mortality rates than the population as a whole.

JEOPARDY! I Can’t Believe It’s Not JEOPARDY!

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True or False? In randomized clinical trials, patients are assigned to different groups by an objective group of scientists and physicians. FALSE Patients are usually assigned through a computer. Neither the patients nor the doctors can choose the group they want.

In Many Clinical Trials, Participants Are Placed into Different Groups All have an equal chance to be assigned to one of two (or more) groups: One gets the most widely accepted treatment The other(s) gets the new treatment being tested, which doctors hope will be better

JEOPARDY! I Can’t Believe It’s Not JEOPARDY!

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True or False? In cancer treatment trials, patients may be given a placebo instead of being appropriately treated for their cancer. FALSE Placebos are never used to substitute for appropriate medical care.

In cancer treatment trials, everyone gets treated –Placebos or “sugar pills” are almost never used instead of appropriate treatment Patients Are Always Treated for Their Cancer

Trial 123 Standard Treatment being studied

Trial 456 Standard & Placebo Standard & “Zing,” a treatment being studied

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True or False? Patients who join clinical trials today aren’t going to benefit from taking part FALSE While it’s not yet known if the new treatment is going to work better than what is currently used, patients can and do benefit from participating.

 Open to many patients, even for first treatment –“The best management for any patient with cancer is in a clinical trial.” (NCCN, 2008) –“Therapies offered through CCTs should ideally be considered the preferred treatment choice for physicians and patients, if they are available” ( Institute of Medicine, 2010) Placebos never used instead of appropriate medical treatment Helping Individual Patients Today: A High Quality Treatment Option

Chance for survival, , all cancers: 50% Chance for survival, , all cancers 68% The only way we will find better ways to treat cancer is through clinical trials… Also important for future patients

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True or False? In general, doctors will always suggest cancer trials as a treatment option for a patient who is eligible. FALSE Both health care providers and patients lack knowledge about clinical trials.

Cancer Clinical Trials  Researchers “have difficulty” in recruitment and retention, especially among minority groups  Up to 30% of phase III trials close early  Referrals (or encouragement) from PCPs, surgeons and non-participating oncologists needs to be better  Poor understanding among patients and members of the public  Distrust, fear and suspicion

Most cancer patients are unaware that clinical trials were a treatment option Minorities may be as willing to participate in research but are less likely to be asked Consider the “narrow window” of opportunity Who is Offered the Opportunity to Participate?

JEOPARDY! I Can’t Believe It’s Not JEOPARDY!

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What is the main purpose of a clinical trial protocol? a.To allow physicians to individualize each patient’s case b.To ensure high-quality patient care c.To describe how the study will be carried out d.None of the above c. To describe how the study will be carried out

JEOPARDY! I Can’t Believe It’s Not JEOPARDY!

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This is something that ACA mandates… along with 36 states What is insurance coverage for patient costs in cancer clinical trials

Health insurance and managed care providers often do not cover the patient care costs associated with a cancer clinical trial. –What they cover varies by health plan and by study. 36 states currently mandate insurance coverage for these trials. Medicare covers many patient care costs in cancer clinical trials. Fact

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The tragedy of the Tuskegee Study brought this right to all persons participating in any clinical trial. a.Randomized study design b.To be informed about risks c.Informed consent form d.Informed consent process

JEOPARDY! I Can’t Believe It’s Not JEOPARDY!

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Why don’t more patients participate in clinical trials? a.Fear b.Don’t know about them c.Fear that it won’t be paid for by insurance d.Mistrust e.All of the above

JEOPARDY! I Can’t Believe It’s Not JEOPARDY!

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Why are there restrictions as to who can participate on clinical trials? a.To protect patients safety b.To ensure study results are accurate and meaningful c.To limit trials to a certain number of participants d.Both a and b d. To protect patients’ safety and to ensure study results are accurate and meaningful

JEOPARDY! I Can’t Believe It’s Not JEOPARDY!

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In the only study of 6000 cancer patients, this is the percentage that were actually informed about the possibility of receiving treatment through a clinical trial. What is 15%

JEOPARDY! I Can’t Believe It’s Not JEOPARDY!

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20% of all cancer patients; 3% of all cancer patients; Who is eligible for CCT participation vs. who participates in CCTs?

JEOPARDY! I Can’t Believe It’s Not JEOPARDY!

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What is the Informed Consent Process The process of providing all relevant information about the trial's purpose, risks, benefits, alternatives, and procedures to a potential participant.

Informed Consent They must be told about… The purpose The procedures The risks and potential benefits Their individual rights

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FALSE 85% of cancer patients surveyed were uninformed that clinical trials were a treatment option; 75% of them would have been willing to participate True or False? In a national study of 6000 cancer patients, 85% were informed that clinical trials were a treatment option, but declined to participate.

400

True or False? Most patients are uninterested in participating in research FALSE

Almost Final Jeopardy Make Your Wager Now…

Name a barrier for clinical trials from the perspective of a) participating oncologist b) cancer patient c) primary care provider; d) non participating oncologist

Awareness Barriers/ Promoters Knowledge Attitudes/Beliefs Self-Efficacy Organizational Environment Health Literac y Opportunity Barriers/Promoters Provider Knowledge Provider Attitudes/Beliefs Eligibility/Exclusions by Design Access Medical Insurance Advanced Disease Co-morbidity Organizational Environment Acceptance/Refusal Barriers/Promoters Perceived Harms/Benefits Trust in Sponsor/Investigator Self-efficacy Altruism Religious Beliefs Personal Experience No Cost Treatment Financial Incentives Timing Opportunity Awareness Acceptance/ Refusal

Final Jeopardy Make Your Wager Now…

Name 3 risks and 3 benefits for patients who choose to take part in clinical trials

Final Jeopardy Possible Answers… BENEFITS Health care provided by leading physicians in the field of cancer research Access to new drugs and interventions before they are widely available Close monitoring of your health care and any side effects If the approach being studied is found to be helpful, patient may be among the first to benefit An opportunity to make a valuable contribution to cancer research

RISKS New drugs and procedures may have unknown side effects or risks New drugs and procedures may be ineffective, or less effective, than current approaches Even if a new approach has benefits, it may not work for all Final Jeopardy Possible Answers…