I-SPY2 Coordinator Training: Interacting With Patients

1. I-SPY2 Coordinator Training: Interacting With Patients

2. Topics  • Why do patients participate in clinical trials? • Overview of I-SPY2: Interacting with patients • Helping patients decide whether or not to participate in the I-SPY2 clinical trial • Patient support materials and services • Recruitment & retention

3. What is a Clinical Trial? • A research study that carefully tests new ways to prevent, diagnose, or treat diseases like breast cancer • Only patients who choose to take part in them • An important way to advance science and develop better treatments for patients with diseases similar to those of participants in the trial • Patients are typically randomly assigned to receive standard treatment OR standard treatment plus and investigational drug

4. What are the Pros and Cons of Participating in a Clinical Trial? • Treatment at a Comprehensive Cancer Center, by a team of first rate team of clinicians • More, and possibly better attention • Potential to receive a new, beneficial drug • Opportunity to contribute to the advancement of science • Possible need to travel a further distance for your cancer treatment • Possibility of receiving a new drug that provides no additional benefit but may add side effects • Additional visits to the clinic and laboratory procedures Pros Cons

5. The “Right” I-SPY 2 Participants • Patients who reflect the diversity of people affected by breast cancer • Patients who understand the pros and cons of being in a clinical trial • Patients who are comfortable with neoadjuvant treatment • Patients who understand and are likely to comply with the incremental research procedures that will be required by I-SPY2 participants • Patients who understand the investigational nature of incremental drugs

6. The “Wrong” I-SPY 2 Participants • Patients who want to do whatever their clinician suggests, whether or not they understand • Patients who are so emotionally and/or cognitively distressed as to be unable to adequately understand the consequences of participating in a clinical trial

7. Useful Resources About Participation in Clinical Trials • From NCI: http://www.cancer.gov/clinicaltrials/learning/clinical-trials-education-series • From Dana Farber: http://www.dana-farber.org/res/clinical/trials-info/default.html • From ACS: http://www.cancer.org/docroot/ETO/content/ETO_6_3_Clinical_Trials_-_Patient_Participation.asp

8. Topics • Why do patients participate in clinical trials? • Overview of I-SPY2: Interacting with patients • Helping patients decide whether or not to participate in the I-SPY2 clinical trial • Patient support materials and services • Recruitment & Retention Plan 

9. Regularly Remind Patients of the Goals and Objectives of I-SPY2 The purpose of I-SPY2 is to learn: • If patients with breast cancer benefit from adding an investigational agent to their standard chemotherapy before surgery • What effects, good and bad, the combination of therapy has on your cancer • What changes this combination of drugs has on your tumor through Magnetic Resonance Imaging Clinical Trials are the way to advance our understanding of cancer and find better treatments!

10. I-SPY2 Steps Recruit Patients Enroll Patients Treat Patients

11. Recruiting Patients Make Patients Aware of Trial Screening Consent Discussion Yes Interest? No Done I-SPY 2 Brochure I-SPY 2 Patient Website, DVD

12. Enrolling Patients Randomize (Determine Treatment) Treatment Consent Discussion Yes Yes Eligible? Agree? Yes No No Non-Eligibility Discussion I-SPY 2 Patient Website & DVD Decline Questionnaire

13. Topics  • Helping patients decide whether or not to participate in the I-SPY2 clinical trial • Unusual features of the I-SPY2 consenting process • Adjusting to the Emotional and Cognitive Compromise Experienced by Most Newly Diagnosed Breast Cancer Patients • Individualizing the Consent Process • Anticipating and Answering Patient Questions about I-SPY2 • Role Play

14. Key Points Patients Should Know About I-SPY2 • They will receive their chemotherapy prior to surgery (neoadjuvant treatment) • Their surgery will take place in approximately six months. • Chemotherapy will include standard drugs (Taxol, AC, and Herceptin in HER2+). Additionally patients will be randomized to receive on of many investigational drugs, or no additional drugs (~20%) • If a patient is randomized to receive an investigational drug, it will be selected because it is expected to work for their type of cancer • There will be 3 more biopsies and 3 extra MRIs that would not be required if they were not in the trial • Research drugs and procedures will be paid for by trial sponsors, but patients or their insurers will be responsible for standard treatment

15. I-SPY 2 Two Stage Consent Process Treatment Consent Patient On Study Randomized to treatment arm based on stratifying biomarkers Yes Screening Consent Is patient eligible? Patient not on study Not considered good candidate for chemotherapy No

16. Who Can Participate in I-SPY2? • Newly diagnosed patients with stage II or III breast cancer • > 2.5cm tumor • Biomarkers profile that indicates that you are at a high risk of recurrence with standard treatment—based on: • ER/PR • Her2 • MammaPrint

17. Two Step Informed Consent Process:Screening Consent • Provides general description of I-SPY2 • Goals • Patient Schedule • Risks and Benefits • Financial Issues • Does not provide specific information about drugs • Provides specific information about eligibility requirements and screening procedure • Requests patients’ agreement to be screened

18. Two Step Informed Consent Process:Treatment Consent • Follows patient randomization • Provides detailed description of I-SPY2 • Goals • Patient ScheduleSpecific drug side effects • Risks and benefits • Financial issues • Withdrawal process • Requests patients’ agreement to be treated in I-SPY2

19. If a Patient Declines to Sign Either Consent • Thank her for consider the trial • Solicit her concerns • Start open ended question • Then cue her with the categories on the Transcend screen (see next slide) • Try to drill down to get understand specifics • Capture information on the CRF • Ask patient to complete the pre-stamped and addressed “Patient Decline Questionnaire”

20. If a Patient Declines to Sign Either Consent (Continued) • Also, ask her if she would be willing to fill out an anonymous questionnaire describing her concerns • If yes—give her some private time to do so • If not—ask her to take home the questionnaire and consider completing later in the week, and dropping it in the mail

21. Patient Decline Section of Transcend • Did patient sign Consent? • Yes • No – reasons why not (check all that apply) • Patient was found to be ineligible • Patient decided against being in any trial • Treatment Concerns • Neodjuvant therapy • AC • Investigational drug • Too many biopsies • Too many MRIs • Insurance and/or financial Concerns • Logistic concerns • Too many extra clinic visits • Too far from home • Wants to be treated by local doctor • Family and/or job issues • Other

22. Patient Decline Mailer

23. Key Points for Informing Patients who are not Eligible for I-SPY2 • Not being eligible is not a bad thing • It just means that your tumor type is not matched to the investigational drugs • Your tumor is likely to respond well to standard treatment alone • However you may want to participate in a different clinical trial • We will maintain a list of potential trials, using www.breastcancertrials.org

24. Topics • Helping patients decide whether or not to participate in the I-SPY2 clinical trial • Unusual features of the consenting process • Adjusting to the Emotional and Cognitive Compromise Experienced by Most Newly Diagnosed Breast Cancer Patients • Individualizing the Consent Process • Anticipating and Answering Patient Questions about I-SPY2 • Role Play 

25. Exercise – Close Your Eyes and Experience • You’ve just been diagnosed with cancer • You don’t know much about cancer, but you assume it’s a death sentence • You don’t know much about cancer treatment, but you believe it will make you very sick and bald • You are not familiar with the hospital, but and being in it makes you very uncomfortable

26. Exercise – Close Your Eyes and Experience (continued) • You are already close to the edge due to: • Family challenges -- spouse, kids, aging parents • Financial challenges • Work issues • How can you get through this? • Can you just give up? • Are you dreaming? No, but this will interfere with your sleep for some time to come, and likely change the rest of your life, no mater how long that is!

27. Patients • Overwhelmed • Emotional traumatized • Cognitively compromised • Understanding of cancer treatment and treatment trials • Information needs, cognitive style • Methods of coping • Family and financial situation • Age, ethnicity, job status Are All the Same Each is Unique

28. Ways to Compensate for Patients’ Distressed State • Validate patients emotions • Slow down • Engage others • Ask about patients emotional state, needs, feelings • Ask about patients cognitive state, needs, preferences • Require patient to paraphrase, using their own words • Continually solicit feedback and questions from patients and adjust accordingly • Use multiple formats—words, pictures, diagrams, models • Give patient take away material and follow-up phone numbers

29. Improving the Consent Discussion Getting Starting Patient Interaction Closing • Ask the patient to explain the situation • Build on what the patient has told you • Ask the patient about her questions & concerns • Respond to each of the patients issues, one by one • Have the patient paraphrase your responses to ensure understanding • Raise critical issues that the patient has not raised Adapted from CISN (http://cisncancer.org/) • Prepare yourself for the meeting, including emotionally • 5 questions to ask your patient • Empathize with the patient’s predicament • Close with discussion of “next steps” • Provide patient with “take-homes

30. Topics • Helping patients decide whether or not to participate in the I-SPY2 clinical trial • Unusual features of the I-SPY2 consenting process • Adjusting to the Emotional and Cognitive Compromise Experienced by Most Newly Diagnosed Breast Cancer Patients • Individualizing the Consent Process • Anticipating and Answering Patient Questions about I-SPY2 • Role Play 

31. Five Questions to Help Personalize the Consent Process • How much does this patientalready understand about her condition and options? • How much does this patientwant to know about her condition and options? (e.g., Is she a “blinder” or “monitor?) • What are the issues that will be most important to this patient? • What are the best ways to help this patientunderstand what she wants/needs to understand? • What additional support can I offer to this patient? Adapted from CISN (http://cisncancer.org/)

32. 1.How much does this patientalready understand about her condition and options? • Start by asking the patient to explain how she understand her diagnosis and treatment options • Depending on her answer, cover the topics she needs, in the following order: • Her diagnosis • Standard of care • What a clinical trial is • How participating in I-SPY2 would be different from standard of care

33. 2. How much does this patientwant to know about her condition and options? • Some patients want to know everything, including statistics • Cover key concepts first, but let them know how to access more information • Some patients do not want much information • Go over the most critical concepts only • Some patients do not want to know anything; they want their doctor to decide • The decision needs to be the patient, and be based on understanding their options • You must be sure they understand the pros and cons of participating in I-SPY2

34. 3. What are the issues that will be of most important to this patient? Survival Getting through treatment—e.g., side effects Family issues Job issues Logistics, travel Insurance and/or other financial concerns Complementary and/or alternative treatments Other

35. 4. What are the best ways to help this patientunderstand what she wants/needs to understand? • Be sensitive to the patient’s culture • Involve a significant other or translator • Use analogies and metaphors • Provide or avoid mentioning statistics • Providing pictures, flow charts, plus/minus table (see www.ispy2.org ) • Providing take homes (e.g., brochures, DVD) • Other

36. 5. What additional support can I offer to this patient? See www.ispy2.org/locations Psychology referral Social worker referral Patient navigator referral Clergy referral Access to another patients Local support groups Other

37. Topics • Helping patients decide whether or not to participate in the I-SPY2 clinical trial • Unusual features of the I-SPY2 consenting process • Adjusting to the Emotional and Cognitive Compromise Experienced by Most Newly Diagnosed Breast Cancer Patients • Individualizing the Consent Process • Anticipating and Answering Patient Questions about I-SPY2 • Role Play 

38. Likely Patient Treatment Issues • Neoadjuvant treatment—postponing surgery • Chemo side effects • Taking an investigational drug • The particular investigational drug • Not receiving an investigational drug • Extra MRIs and/or biopsies • Other See www.ispy2.org/about Issue Potential Resolution

39. Other Likely Patient Concerns • Mortality • Family issues • Job issues • Insurance concerns • Time, cost, additional inconvenience of extra clinic visits • Distance to trial site • Change of doctor • Other Issue Potential Resolution

40. Topics • Helping patients decide whether or not to participate in the I-SPY2 clinical trial • Unusual features of the I-SPY2 consenting process • Adjusting to the Emotional and Cognitive Compromise Experienced by Most Newly Diagnosed Breast Cancer Patients • Individualizing the Consent Process • Anticipating and Answering Patient Questions about I-SPY2 • Role Play 

41. Role Play a Patient Discussion • Divide into groups of three • Assign roles • Patient • Heath care provider • Observer • Role play for ~6 minutes • Debrief with each team member discussing their feelings and observations • Time permitting, rotate roles and scenarios • Select a scenario • Screening consent • Non-eligible discussion • Treatment consent

42. Topics • Why do patients participate in clinical trials? • Overview of I-SPY2 • Helping patients decide whether or not to participate in the I-SPY2 clinical trial • Patient support materials and services • Recruitment & Retention Plan 

43. What I-SPY2 Patient Support Materials are Available? • Introductory brochure • Patient DVD • User friendly I-SPY2 Patient Website (www.ispy2.org ) • Location specific support (can be found at www.ispy2.org/locations )

44. Navigating the Website

45. Navigating the I-SPY2 Website

46. Navigating the I-SPY2 Website

47. Navigating the I-SPY2 Website

48. Navigating the I-SPY2 Website

49. Navigating the I-SPY2 Website

50. Network of Strength Hotline (formerly Y-ME) • 24x7 toll free hotline (800-221-2141) • Staffed by trained and certified breast cancer survivors • Free to all callers • Spanish speaking counselors • Interpretation available in over 150 languages • E-mail option • Match programs • Patient specific requests (e.g., diagnosis, treatment, demographics) • Male breast cancer matches • Partner’s match program