I-SPY2 Coordinator Training: Interacting With Patients
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Transcript of I-SPY2 Coordinator Training: Interacting With Patients
1. Why do patients participate in clinical trials?
2. Overview of I-SPY2: Interacting with patients
3. Helping patients decide whether or not to participate in the I-SPY2 clinical trial
4. Patient support materials and services
5. Recruitment & retention
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
Pros Cons
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
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
5
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
6
◦ 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
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
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!
Recruit Patients
Enroll Patients
Treat Patients
I-SPY 2 Brochure
Make Patients Aware of
Trial
Screening Consent
Discussion
Interest?
Done
Yes
No
I-SPY 2 Patient
Website, DVD
Randomize(Determine Treatment)
Eligible?
Agree?Treatment Consent
Discussion
No
Yes
Non-Eligibility
Discussion
Decline Questionnair
e
No
Yes
Yes
I-SPY 2 Patient
Website & DVD
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
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
Screening Consent
Patient not on study
Not considered good candidate for chemotherapy
Treatment Consent
Patient On StudyRandomized to
treatment arm based on stratifying biomarkers
No
Yes
Is patient eligible?
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
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
Follows patient randomization Provides detailed description of I-SPY2
◦ Goals◦ Patient Schedule
Specific drug side effects◦ Risks and benefits◦ Financial issues◦ Withdrawal process
Requests patients’ agreement to be treated in I-SPY2
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”
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
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
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
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
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
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!
Are All the Same Each is Unique
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
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
Getting Starting
•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
• 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/)
ClosingPatient
Interaction
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
1. How much does this patient already understand about her condition and options?
2. How much does this patient want to know about her condition and options? (e.g., Is she a “blinder” or “monitor?)
3. What are the issues that will be most important to this patient?
4. What are the best ways to help this patient understand what she wants/needs to understand?
5. What additional support can I offer to this patient? Adapted from CISN
(http://cisncancer.org/)
1. How much does this patient already 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
2. How much does this patient want 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
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
4. What are the best ways to help this patient understand what she wants/needs to understand?
Be sensitive to the patient’s cultureInvolve a significant other or translatorUse analogies and metaphorsProvide or avoid mentioning statisticsProviding pictures, flow charts, plus/minus table (see www.ispy2.org )
Providing take homes (e.g., brochures, DVD)
Other
5. What additional support can I offer to this patient?
Psychology referral Social worker referral Patient navigator referral Clergy referral Access to another patients Local support groups Other
See www.ispy2.org/locations
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
Issue Potential Resolution
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
Mortality Family issues Job issues Insurance concerns Time, cost, additional
inconvenience of extra clinic visits
Distance to trial site Change of doctor Other
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
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 scenarioo Screening consento Non-eligible discussiono Treatment consent
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
Introductory brochure Patient DVD User friendly I-SPY2
Patient Website (www.ispy2.org )
Location specific support (can be found at www.ispy2.org/locations )
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
A select group of experienced peer counselors will be specifically trained about I-SPY2 (primarily based on www.ispy2.org )
One of the counselors will be Spanish speaking
Once assigned to a patient, the counselor will periodically (approximately once a month) call to check on patient
Provide participants with an opportunity to discuss their diagnosis and treatment issues with trained peer counselors:◦ Validation of emotions and support for dealing
with them◦ Questions about treatment or trial
Help patients anticipate next steps in treatment
Encourage participants to comply with trial requirements and raise concerns with their health care provider
During the treatment consent, patients will be provided with “Network of Strength Counselor Request”◦ If a patient fills out and returns the self-
addressed/pre stamped form, she will be assigned an I-SPY2 Peer Counselor
◦ Patients who do not wish a specially assigned counselor may still call the hotline (800-221-2141) any time (24x7)
Peer Support Facing a cancer diagnosis can be traumatic and making treatment decisions can be challenging, including whether or not to participate in a clinical trial. Many women in your situation find it helpful to speak with someone who has already gone through this experience. The Breast Cancer Network of Strength (formerly Y-ME) was founded in 1978 to provide peer-to-peer support to meet the needs of newly diagnosed breast cancer patients. They run a 24-hour, 7-days a week hotline (800-221-2141) that is staffed by trained and certified breast cancer survivors to provide emotional support, information and help people affected by breast cancer. Spanish and English counselors are available to answer calls at all times, and interpreters are available for callers who are not English or Spanish speakers. This service is available to anyone at any time, even if you do not join the I-SPY 2 TRIAL.Are you enrolling in the I-SPY 2 TRIAL?If you are enrolling in the I-SPY 2 TRIAL, you can have a Breast Cancer Network of Strength counselor who has been trained to know about the trial assigned to you. She will call you and schedule regular call, approximately once per month, as you are undergoing your treatment. The counselor can help you talk about the emotions you are feeling with your diagnosis and treatment, discover useful ways to coping, identify questions you have for your doctors, and help answer questions about I-SPY 2 study procedures.Just provide the following information, fold and place in the mail.
Patient’s Name:Preferred Phone Number:Call Time Preferences:EmailTrial Site:Enrollment Date”Biomarker Profile:Treatment Arm:
To be completed by Network of Strength StaffNetwork of Strength Counselor:Assignment Date:
-
Shortly After Enrolled
After Completion of Taxol
Prior to Surgery
After First Treatment
Following Surgery
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
The single largest reason for patients NOT participating in clinical trials is that they were not ASKED◦ Local surgeons/oncologists will be key to making
patients aware of the opportunity to participate in I-SPY2
◦ Make sure local and referring surgeons/oncologists are aware of I-SPY 2 and have access to patient support materials
◦ Identify their objections and help us remedy them
Ensure that I-SPY2 participants reflect the diversity of people diagnosed with breast cancer
Ensure patients who are enrolled in I-SPY2 have adequate emotional support, so they comply with all requirements and complete the trial
Goal: Summing over trial sites, I-SPY2 patients should reflect the diversity of US women affected by breast cancer
Actions:◦ Travel reimbursement for research visits◦ Proactive recruitment of trial sites that over
represent minorities◦ Identify potential affiliate and/or satellite
hospitals that might partner with main I-SPY2 sites
◦ Proactive recruitment of patients from under represented minorities Targeted advocacy organizations (e.g., ICC) Targeted community outreach Targeted publications
Actions Continued:◦ Develop and deliver culturally sensitive and
targeted workshops on participation in clinical trials in general and I-SPY2 in particular
◦ Ensure that all of our patient materials are culturally sensitive and include pictures that reflect diverse populations
◦ Translate the Informed Consent and Recruiting Brochure into Spanish and/or other languages
◦ Identify language translation services that are available at each site
◦ Identify potential affiliate and/or satellite hospitals that might partner with main I-SPY2 sites
Quarterly by Trial Site◦ Which sites are exceeding expectations? What
can we learn from them?◦ Which sites are failing to meet expectations?
How can we remedy this? Quarterly by Patient Biomarker Profile and
Treatment Plan Bi-annually for adequate diversity
Problem Potential Solution
Too few patients are offered trial
Educate clinicians at trial sites Recruit more trial sites Increase national publicity
Too many patients decline screening consent
Educate consenters Improve patient material Assess reasons for decline
Too many patients decline treatment consent
Educate consenters Improve patient material Assess reasons for decline Look for variation by treatment
arm
Problem Potential SolutionDistribution of patients by biomarker profile does not reflect distribution in populationV
Identify competing trials for specific profiles at specific sites
Over recruit from other sites
Distribution of patients declining treatment varies by treatment assignment
Clarify whether the issue is based on rejecting standard of care or a particular investigational agent
Consider over recruiting controls and/or dropping problematic investigational agents
Inadequate diversity Recruit sites in more diverse communities
Increase targeted promotion
“The only dumb question is the one not asked”
I-SPY2 patient brochure I-SPY2 patient DVD I-SPY2 Patient Decline Mailer Network of Strength Peer Counselor
Request Mailer