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