Transcript Slide 1

April 2010
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Ensure all counselors are familiar with the
pros and cons of participation in clinical
trials
Ensure all counselors are familiar with
patient requirements and schedules that
are involved in the I-SPY 2 clinical trial
Provide counselors with suggestions for
assisting I-SPY 2 patients
Ensure that counselors are familiar with
appropriate I-SPY 2 expectations and
record keeping procedures
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  The what and why of clinical trials
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Introduction to I-SPY 2
I-SPY 2 patient support materials
Supporting patients undergoing
neoadjuvant treatment
Network of Strength processes for
I-SPY 2
Q & A and Summary
3
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Research that carefully tests new ways to
prevent, diagnose, or treat diseases like breast
cancer
A study that includes only patients who choose
to participate
An important way to advance science and
develop better therapies for patients with
diseases similar to those being treated in the
trial
A method whereby patients are randomly
assigned to receive standard treatment OR
standard treatment plus an investigational drug
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Pros
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
Cons
Treatment by a team of first
rate clinicians at a
comprehensive cancer
center
More, and possibly better,
attention
Potential to receive a new,
beneficial drug
Opportunity to contribute
to the advancement of
science
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5
Possible need to travel
farther for treatment
Possibility of receiving a
new drug that provides no
additional benefit but may
add side effects
Additional visits to the
clinic and additional
laboratory procedures
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Enable advancement of science
Provide a good option for patients seeking
treatment
Are not right for everyone
Should inform patients about pros and cons
Never pressure patients to participate
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◦ From NCI:
http://www.cancer.gov/clinicaltrials/learning/clinic
al-trials-education-series
◦ From Dana Farber:
http://www.dana-farber.org/res/clinical/trialsinfo/default.html
◦ From ACS:
http://www.cancer.org/docroot/ETO/content/ETO_
6_3_Clinical_Trials_-_Patient_Participation.asp
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The what and why of clinical trials
  Introduction to I-SPY 2
 I-SPY 2 patient support materials
 Supporting patients undergoing
neoadjuvant treatment
 Network of Strength processes for
I-SPY 2
 Q & A and Summary

8
The purpose of I-SPY 2 is to learn:
 Whether patients with breast cancer benefit
from adding an investigational drug to
standard chemotherapy
 Which investigational drugs are most likely to
work for which subtypes of breast cancer,
based on biomarkers
 What changes these drugs make on tumor
biomarkers and MRIs
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Women who:
 Are newly diagnosed with stage II or III breast
cancer
 Have a tumor equal to or greater than 2.5cm
 Have a biomarker profile indicating a high
risk of recurrence with standard treatment,
based on:
◦ ER/PR status
◦ HER2 status
◦ MammaPrint results
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Recruit
Patients
Enroll
Patients
Treat
Patients
Peer
Counselors
11
Support
Patients
Make
Patients
Aware of
Trial
Interest
?
I-SPY 2
Brochure
Done
No
Yes
Screening
Consent
Discussion
Agree?
I-SPY 2 Patient
Website; DVD
Decline
Questionnaire
12
Yes
Eligible
?
No
Non-Eligibility
Discussion
Yes
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Provides general description of I-SPY 2
◦
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Goals
Patient schedule
Risks and benefits
Financial issues
Provides specific information about
eligibility requirements and screening
procedure
Does not provide specific information
about drugs
Requests patient’s agreement to be
screened
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Eligible
?
Yes
Yes
Randomize
(Determine
Treatment)
Treatment
Consent
Discussion
No
Non-Eligibility
Discussion
Agree?
No
I-SPY 2 Patient
Website & DVD
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Decline
Questionnaire
Yes
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Follows patient randomization
Provides detailed description of I-SPY 2
◦ Goals
◦ Patient schedule
Specific drug side effects
 Standard drugs (Taxol and AC) in treatment consent
 Herceptin and experimental drugs in supplemental
consent
◦ Risks and benefits
◦ Financial issues
◦ Withdrawal process
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Requests patient’s agreement to be
treated in I-SPY 2
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During treatment, informed consent patients
are offered phone calls of support from a
Network of Strength peer counselor; if
interested, patients sign and return a prestamped request form.
Patients may, alternatively, note the phone
number and call if and when they please.
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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-day
a week Support Center (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 calls, 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 cope, 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.
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Name:
Address:
Nancy L. Nixon
Director--Contact Center
Breast Cancer Network of Strength(r)
300 W. Adams St., Suite 430
Chicago, IL 60606
Date:
Patient’s Name:
Preferred Phone Number:
Call Time Preferences:
Email:
Primary Language:
Trial Site:
Enrollment Date:
Biomarker Profile:
Treatment Arm:
To be completed by Network of Strength Staff
Network of Strength
Counselor:
Assignment Date:
Screening
MRI
Biopsy
Blood Draw
MUGA/Echo
PET/CT Scan
R
a
n
d
o
m
i
z
e
O
n
S
t
u
d
y
Taxol +/- Herceptin
+/- New Drug
(12 weekly cycles)
MRI
Biopsy
Blood Draw
AC
(4 monthly cycles)
MRI
Blood Draw
S
u
r
g
e
r
MRI
y
Blood Draw
Tissue
Treatment
Consent
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Chemotherapy is given prior to surgery
(neoadjuvant treatment).
Standard chemotherapy includes Taxol, AC,
and Herceptin (if HER2+).
Surgery takes place approximately 6 months
after the first treatment.
Hormonal treatment and/or radiation therapy
is given after surgery to patients, if indicated.
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Three additional biopsies
Three additional MRIs
Investigational drugs—given to 80% of
patients
Investigational drugs—given because they are
expected to work for a patient’s specific type
of breast cancer
Research drugs and procedures—paid for by
trial sponsors, but patients or their insurers
pay for standard treatment
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Shortly After
Enrolled
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After First
Treatment
After Completion
of Taxol
Prior to Surgery
Following Surgery
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Tab 4
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Tab 6
I-SPY 2 Trial Site Contacts
I-SPY 2 Fact Sheet
I-SPY 2 Executive Summary
Nature Article
I-SPY 2 Press Release
I-SPY 2 Advocate FAQs
I-SPY 2 Patient Website
Content
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I-SPY 2 Overview Brochure
I-SPY 2 Patient DVD
NCI Taking Part in Cancer
Treatment Research Studies
NCI Chemotherapy and You:
Support for People With
Cancer
NCI Adjuvant and
Neoadjuvant Therapy for
Breast Cancer
Agendia MammaPrint Patient
Brochure
The what and why of clinical trials
 Introduction to I-SPY 2
  I-SPY 2 patient support materials
 Supporting patient undergoing
neoadjuvant treatment
 Network of Strength processes for
I-SPY 2
 Q & A and Summary
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Introductory brochure
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Patient DVD
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User friendly I-SPY 2 patient
website
Other support provided by
individual trial sites
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The what and why of clinical trials
 Introduction to I-SPY 2
 I-SPY 2 patient support materials
  Supporting patients undergoing
neoadjuvant treatment
 Network of Strength processes for
I-SPY 2
 Q & A and Summary

31
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Provide participants with an opportunity to
discuss their diagnosis and treatment
issues with trained peer counselors
◦ Validation of emotions and support for handling
them
◦ Questions about the trial
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Encourage participants to comply with trial
requirements and raise concerns with their
health care provider
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Issue
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Potential Resolution
Neoadjuvant therapy
Multiple biopsies
Multiple MRIs
Investigational drugs
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Issue
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Potential Resolution
Potential insurance
concerns
Time, cost, and
inconvenience of extra
clinic visits
Distance to trial site
Change of doctor
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Issue
Potential Resolution
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Shortly After
Enrolled
After First
Treatment
-
After Completion
of Taxol
Prior to Surgery
For all call:
• Check current status and discuss
patient issues
• Check compliance and help patient
articulate issues for health care
provide
• Anticipate next steps of treatment
• Schedule next call
Following Surgery
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Ideal Time: Within one week of enrollment
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Goals of Call
◦ Check current status and discuss patient issues
◦ Check compliance and assist patient to identify issues for
health care providers
◦ Review key components of I-SPY 2
◦ Remind patient of treatment team members and roles
◦ Suggest review of I-SPY 2 support material, if needed
◦ Anticipate next steps of treatment
◦ Schedule second call
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Suggestions
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Caller Concerns
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Wants to know more about MammaPrint test
Is having second thoughts about participating in a
clinical trial—extra visits and being a “guinea pig”
Is concerned about neoadjuvant therapy
Peer References
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MammaPrint brochure and website:
http://www.agendia.com/pages/about_mammaprint
/75.php
“Taking Part in Cancer Treatment Research Studies”
and I-SPY 2 DVD
“Adjuvant and Neoadjuvant Therapy for Breast
Cancer”
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Caller Concerns: Feeling anxious and a bit
fearful of starting the clinical trial
Peer Counselor Support
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“Feeling anxious and fearful is common when
starting a clinical trial.”
“It’s important to remember that you will be
treated at a comprehensive cancer center and
will receive standard treatment and possibly a
new beneficial drug.”
“Those leading the clinical trial want you to do
well and will monitor you very closely.”
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Divide into groups of three
Assign roles
◦ Patient
◦ Peer counselor
◦ Observer
Role play for about 6 minutes
Debrief with group members to discuss their
feelings and observations
Rotate roles and scenarios, time permitting
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Ideal Time: Within two weeks of first
chemo treatment
Goals of Call
◦ Check current status and discuss patient issues
◦ Check compliance and assist patient to identify
issues for health care providers
◦ Review of key components of I-SPY 2
◦ Remind patient of treatment team members and
roles
◦ Suggest review of I-SPY 2 support material, if
needed
◦ Anticipate next steps of treatment
◦ Schedule third call
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Suggestions
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Ideal Time: Between next to the last
Taxane and second AC
Goals of Call
◦ Check current status and discuss patient issues
◦ Check compliance and assist patient to identify issues
for health care providers
◦ Review key components of I-SPY 2
◦ Remind patient of treatment team members and roles
◦ Suggest review of I-SPY 2 support material, if needed
◦ Anticipate next steps of treatment
◦ Schedule fourth call
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Suggestions
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Caller Concerns
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Patient worries that her cancer is not shrinking
Patient wonders why she needs AC when her scans are
looking good
Peer Counselor Support
‣ Not Shrinking. Suggest that patient discuss her MRIs with her
doctor; remind her that she still has more treatment and not
all cancer reacts immediately to chemotherapy.
‣ Shrinking. Remind her that chemo is meant to kill any cancer
cells throughout her whole body, not just in her breast. AC is
still standard of care, but some patients do forego it. She
should discuss this with her doctor.
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Caller Concern: Side effects, such as nausea and joint
pain, that might be the result of some chemo
Peer Counselor Support
Possible side effects of chemo can be scary; however, she
should remember that many people have no, or just a few,
side effects.
Taxol and Herceptin may cause mild muscle pain and nausea
The doctor can prescribe several medications that will help
with symptoms.
Recommend that she keep her clinical team informed of any
side effects, ensuring that appropriate meds are given and
enabling her to feel her best during the trial.
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
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
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
Divide into groups of three
Assign roles
◦ Patient
◦ Peer counselor
◦ Observer
Role play for about 6 minutes
Debrief with group members to discuss their
feelings and observations
Rotate roles and scenarios, time permitting
45
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
Ideal Time: About one week prior to
surgery
Goals of Call
◦ Check current status and discuss patient issues
◦ Check compliance and assist patient to identify
issues for health care providers
◦ Review key components of I-SPY 2
◦ Remind patient of treatment team members and
roles
◦ Suggest review of I-SPY 2 support material, if
needed
◦ Anticipate next steps of treatment
◦ Schedule fifth call

Suggestions
◦
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
Ideal Time: About one week after surgery

Goals of Call
◦ Check current status and discuss patient issues
◦ Discuss outcome of surgery (e.g., pathological complete
response—pCR)
◦ Discuss follow-up
◦ Discuss continuing concerns
◦ Discuss availability of future support
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Suggestions
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◦
◦
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Caller Concerns
‣ Having second thoughts about not having had
reconstructive surgery
‣ Worrying about not having a pathological complete
response (pCR)
‣ Experiencing late side effects
Peer Counselor Support
‣ Reconstruction. Options and/or a recommendation for
a consultation with a plastic surgeon can be discussed;
reconstruction has no time limit.
‣ pCR. Many patients do not have pCR but do very well,
especially those whose tumor was ER+ and who haven’t
started endocrine therapy.
‣ Late Side Effects. Such fears are common; if something
unusual persists, she should talk to her oncologist.
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Caller Concern: Wants to know how to get
answers to her ongoing concerns during
the clinical trial
Peer Counselor support
‣ Get questions answered now and throughout
the clinical trial.
‣ Maintain an open conversation with the
medical team.
‣ Put together a list of questions for the doctor .
‣ Search a few websites that offer a wealth of
information on the clinical trial.
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




Divide into groups of three
Assign roles
◦ Patient
◦ Peer counselor
◦ Observer
Role play for about 6 minutes
Debrief with group members to discuss their
feelings and observations
Rotate roles and scenarios, time permitting
50
Caller Concern: Caller wants to know how to get
answers to all her ongoing concerns during the
clinical trial
Peer Counselor support
‣ Get questions answered now and throughout the
clinical trial.
‣ Maintain an open conversation with the medical
team.
‣ Put together a list of questions for the doctor.
‣ Search a few websites that offer a wealth of
information on the clinical trial.
51
The what and why of clinical trials
 Introduction to I-SPY 2
 I-SPY 2 patient support materials
 Supporting patients undergoing
neoadjuvant treatment
  Network of Strength processes for
I-SPY 2
 Q & A and Summary

52
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Getting assigned to new patients
Scheduling calls
Addressing additional patient concerns
Addressing additional peer counselor
questions
Maintaining information in the Network of
Strength Support Center
Participating in monthly conference calls
53
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During the treatment consent, patients will
be provided with a “Network of Strength
Counselor Request”
◦ If a patient fills out and returns the selfaddressed/pre-stamped form, she will be
assigned an I-SPY 2 peer counselor
◦ Patients who do not wish a specially assigned
counselor may still call the hotline at 800-2212141 any time (24x7)
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
Nancy Nixon assigns peer counselors
Peer counselors schedule calls with patients
54
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 Support Center (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.
55
Name:
Address:
Nancy L. Nixon
Director--Contact Center
Breast Cancer Network of Strength(r)
300 W. Adams St., Suite 430
Chicago, IL 60606
Date:
Patient’s Name:
Preferred Phone Number:
Call Time Preferences:
Email:
Primary Language:
Trial Site:
Enrollment Date:
Biomarker Profile:
Treatment Arm:
To be completed by Network of Strength Staff
Network of Strength
Counselor:
Assignment Date:
Situation



Appropriate Response
Patient has questions
about I-SPY 2 or other
concerns that you cannot
address
You have questions
about how best to
support patients in
I-SPY 2
You have questions
about logistics



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Tell her to talk to or raise
these issues with her
health care provider
Contact Bev Parker
[email protected]
(630) 373-5722
Contact Nancy Nixon
nnixon@networkofstreng
th.org
(312) 294-8552
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The what and why of clinical trials
 Introduction to I-SPY 2
 I-SPY 2 patient support materials
 Supporting patients undergoing
neoadjuvant treatment
 Network of Strength processes for
I-SPY 2
  Q & A and Summary

69
“The only dumb question is the
one not asked.”
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