Accrual Strategies &Maintaining Compliance in Cancer Prevention Protocols

1. Accrual Strategies &Maintaining Compliance in Cancer Prevention Protocols

2. Prevention is so much better then cure because it saves the labor of being sick. Thomas Adams 16th Century

4. Prevention is still in its infancy in cancer clinical trials in the United States. It obviously has a lot of potential as does the new born infant It will require your help and guidance as it grows

5. What is now proved was once only imagined William Blake

6. Change your thoughts and you change the world Norman Vincent Peale

7. If you think you can or you think that you can’t (as it relates to life), you are probably right. We have to get rid of negative thoughts when we move into new areas.

8. Knowledge advances by steps, and not by leaps Lord Macaulay

9. Are you afraid of change?

10. Implementing Research • The number one need of all people (including patients and participants) is acceptance • The number one fear of all peopleis rejection

11. Protocol Barriers It is much easier to follow one’s usual course of practice than to bother with evaluating, educating, and placing the patient on a clinical trial. We have to recognize that your payoff as a health care provider is often that you feel safe when you don’t attempt change, and threatened when you do.

12. By taking the line of least resistance, you reward yourself with apparent comfort and relief from the anxiety that comes from reaching for something else. You will stay in your comfort zone. Fear of the new

13. Accruals • If you are having trouble getting patients on clinical trials, you need to look and see if it is the message or the messenger that may be the problem.

14. A recent Harris poll discovered • The primary reason that women and men do not join clinical trials is because it is not offered to them by a doctor.

15. Accrual Barriers Llewellyn-Thomas et. al., reported that 100 cancer patients who received supplemental education about clinical trials were more likely to go on trial then those who did not. Soc Sci Med 32:35-42

16. Accrual to Treatment Trials • Nationally 3% adults/70-80% children • Comprehensive cancer centers 12% • Some centers 20-30%

17. Accrual • Clinical research: • boosts a centers’ reputation • ACOS criteria • attracts patients seeking access to state-of-the-art therapy (market share) • Physician barriers • Patient barriers

18. Accruals • Problems in prevention trials • There may not be a long term relationship with the physician, therefore, no history and no trust • The thought process that “clinical trials are only for the very sick” • The concept of experimentation

19. Accrual Patients still typically depend on physician expertise for treatment selection. Physician attitudes toward research substantially influences all clinical trial accrual rates. If the patient dose not have a history or relationship with the doctor then there are more obstacles.

20. Accrual to Treatment Trials • Physician’s impact on treatment choice • the majority of patients want “all” information • 69% want to participate in treatment decisions • 25% want the MD to make all the decisions • mostly older people

21. Accrual • Physicians impact on decision to go on a cancer prevention trial • Is a topic that has not been well studied • If a physician has an impact then it will be with the physician that they have developed a relationship with • Patients trust their physician but they may not trust physicians in general

22. Accrual • It is assumed that patients will want “all” information so that they can be involved in the decision making process

23. Accruals • Physicians • If this concept is correct then the physicians who will have the greatest impact in informing and potentially accruing to prevention trials will be the Family Physician, Internist, and Gynecologist.

24. Patients trust their physician and if that physician believes in and recommends treatment with the national trials, the patients will generally go on-study.

25. Developing Trust • Compassion • Recognizing their beliefs, humans are very spiritual beings • Letting them know that you will listen and answer any questions they have • Letting them know that you will be there for them

26. Developing Trust • Give them the time that they deserve. • Don’t look rushed even if you are. • Act as if they are the only patient that you have that day. • Remember that non-verbal language is real.

27. So They Understand • Use terms and concepts that they can relate to. • Don’t talk down to them. • Don’t be arrogant. • Be variable.

28. Physician Barriers • Tracking open protocols this is my personal problem • Complexity of the trials - communicate this to Research Bases • Time involved • Protected time for clinical trials • Paperwork required

29. Clinical Research Nurse • Empower the nurse to get the patients on studies, some trials can be nurse directed • Chart review • Eligibility verification/confirmation • Physician notification • Patient education • Trial documentation

30. Considerations • Make sure you have the infrastructure in place • appropriate staff • selection of trials • Commitment of key physicians

31. Considerations • Enroll the right patients - need compliance • Quality of clinical trials and data is important

32. Communications Patients generally want information, if they are part of a prevention trial then communications become critical as they are a key player and so need to be kept informed. Failure to inform them is not only unethical but it will destroy any trust that you ever hope to build

33. Communications Failure to keep the participants involved will destroy you credibility

34. Patient Perspectives • Receive medical benefits from the clinical trials • Benefit from increased monitoring and care • Peace of mind • Motivated by a desire to help others or a desire to help the investigators.

35. Protocol Barriers • How the protocol is presented • Body language of staff • Tone of voice • Enthusiasm • Conviction that the protocol is the “state-of-the-art” treatment • Talk over the patient and not listening

36. Beliefs • Lack of interest • If you have a lack of interest then you will not put patients on trials. • You may see a decrease in referrals from physicians • Patients will not be referred to go on specific trials • Their colleagues may be able to change their beliefs and practice.

37. Protocol Barriers • When physicians do not feel they can recommend treatment, they should not become investigators • Inappropriate attitudes include: • “I know what the trial will show and if it doesn’t, the results are not believable.” • “I believe one treatment is preferable and expect that this trial will show it.”

38. Protocol Barriers Appropriate attitudes include: “I do not know which treatment is superior and that is the reason I am participating in this trial.”

39. As oncologists we owe society our best effort to cure and prevent cancer, that means placing all patients on clinical trials.

40. Personal Satisfaction There is a lot of satisfaction in putting patients on studies that changes the way we treat our patients. It is humbling when the studies we are using change our biases.

41. If Cancer Control trials are to succeed then you need a champion for the trials in the community. You need someone who will remind others of the trial. When you see a patient with a cancer you think of treatment but you don’t always think of symptom management trials, nor do you think of ancillary studies.

42. Champion • Who do you find as the champion • Try to find someone who is interested • Someone who is not so overburdened that they can not function • Someone you can work with • Someone who is willing to help you

43. Cancer Control trials, although important, represent the new kid on the block. As such it will take longer for some physicians to accept. As new Oncologists come on line then I expect Cancer Control to be seen as important as Treatment trials.

44. Implementing Research • Physician buy in • This is critical, you can not have hubris or ego getting in the way. • There must be agreement that clinical trials represent the “state of the art”. If you can not get physician buy in then don’t bother with clinical trials as it will not work well at your institution.

45. Implementing Research • Physician buy in • If you can get a cadre of physicians who believe in clinical trials you do have the ability to infect the remaining physicians. • It is critical that you believe in the clinical trials process. Then with time and community support you can change some of those who are not participating.

46. Implementing Research • Physician buy in • How to do it. • Be a vocal advocate for the scientific based process • Be critical of non-scientific data • Be honest and humble about the knowledge that we do have • Believe that one clinical trial does not change clinical practice

47. Implementing Research • Physician buy in • How to do it • Be vocal at tumor conferences about what is going on at your clinical research bases • “Walk the walk” don’t just “talk the talk”. There are a lot of people who talk a good show but who don’t produce. Show your commitment.

48. Implementing Research • Physician buy in • How to do it • Don’t refer your patients to physicians who talk your patients out of going onto protocols. • Be willing to educate the physicians who refer patients to you about the value of clinical trials.

49. Implementing Research • Data Management • Make sure that you have adequate support • Make sure that your team understand the importance of research • Have the Clinical Research personnel under your control so that you will have a say in what they do

50. Implementing Research • Data Management • Physicians need to give the physical support that is needed. When CRP come to you don’t make them wait, answer their question so they can get on helping you. • It is generally said that if you have a task and you can get it off your desk in 5 minutes you ought to get it done now.