Patient Support Materials for I-SPY 2 Clinical Trial

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					                    Patient Support for I-SPY 2 Clinical Trial

A variety of patient support materials have been developed to assist patients
understand the trial. The following flow chart shows the sequence of interfacing with
patients in I-SPY 2, as well as the support that you should provide them at each step
along the way (green boxes). Each of these will be described below.

1. Patient Brochure: The Patient Brochure is a multi-color three fold brochure that
   provides a brief overview of I-SPY 2. Copies will be provided during the
   Site Initiation Visit, and can be reordered from Sonia H. Pearson-White,
   Ph.D: The Biomarkers Consortium; FNIH, 301-435-4103; spearson- They can also be downloaded from You
   may want to circulate them to staff in various offices where potential I-SPY
   2 patients are seen. In addition, you may want to make them available in
   your waiting area, or at appropriate public forums. They should certainly be
   provided to any patient who is likely to be eligible for I-SPY 2, at the earliest time in
   her consideration of alternative treatments

2. Patient Website: provides patient friendly information about I-SPY
   2. It will allow patients to identify the information they are interested in, and drill down
   to whatever level of information need they have. The site URL is
   provided on the I-SPY 2 Patient Brochure. You should become
   familiar with the website yourself, and encourage patients to
   access it throughout their treatment. Also, please provide your
   CCSA monitor with suggestions about information that should be
   added and/or ways to improve the navigation.
3. Patient DVD: The Patient DVD is intended for patients who are seriously
   contemplating participating in I-SPY 2. Copies will be provided during the Site
   Initiation Visit, and can be reordered from Sonia H. Pearson-White, Ph.D: The
   Biomarkers Consortium; FNIH, 301-435-4103; It is
   approximately 13 minutes long, includes overview information about clinical trials in
   general, as well as the type of information that should be conveyed in an informed
   consent discussion about I-SPY 2. It can also be viewed on by
   scrolling to the bottom of the homepage. Patients should be given a copy of the DVD
   and/or encouraged to view it on the web with the people who will be helping them

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                     Patient Support for I-SPY 2 Clinical Trial

   make treatment decisions and/or during treatment. Patients may want to view it
   before and/or after a detailed informed consent discussion. Either way, patients
   should be encouraged to write-down questions they have about the material
   discussed in the DVD, which you should be able to answer for them.
4. Decline Questionnaire: While we have tried to make I-SPY 2 a patient friendly
   trial, we recognize that participation in clinical trials is not right for everyone, and
   some aspects of I-SPY 2 may be unattractive to specific patients. To help us better
   design trials in the future we would like to obtain information on
   the reasons that lead patients to decline to participate. This will be
   accomplished in two ways: 1) capturing information on the CRF in
   Transcend; and 2) requesting that the patient complete a “Decline
   Questionnaire” (see attached). Copies the Decline Self-Mailer will
   be provided during the Site Initiation Visit, and can be reordered from Sonia H.
   Pearson-White, Ph.D: The Biomarkers Consortium; FNIH, 301-435-4103; spearson-

   Following is the procedure that should be used when a patient declines to be
   screened or treated in I-SPY 2
       1. If a patient you are consenting decides not to sign either the screening or
          treatment consent, thank her for considering the trial
       2. Solicit her concerns
               Start with an open ended question
               Then cue her with the categories on the Transcend screen (see below)
               Try to drill down to specifics, depending on patients comfort and interest in
                discussing her reasons for refusal
       3. Capture as much information as you have obtained in
          Transcend CRF form
       4. Also, ask the patient if she would be willing to fill out an
          anonymous questionnaire describing her concerns
               If yes—hand her the “Decline Questionnaire Self-Mailer”
                and provide her with some private time to complete it;
                you can then collect it and drop it in the mail
               If not—ask her to take home the questionnaire and consider completing it
                later it in the week, and dropping it in the mail

5. Network of Strength Peer Counselors:
   The Value of Peer Support for Women Recently Diagnosed with Breast
   Cancer: It is well know that patients who have recently been diagnosed with breast
   cancer are often overwhelmed, frightened and cognitively impaired. Making
   treatment decisions and dealing with the strain of treatment is among the most
   traumatic events they are likely to have experienced. Nevertheless, they are often
   significantly helped by peer support provided by breast cancer survivors who are

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                     Patient Support for I-SPY 2 Clinical Trial

   personal acquaintances, participants in support groups and/or counselors on
   hotlines. Personal interaction with people who have been through a similar
   experience provides a validation of emotions that cannot be provided by others.
   Also, it provides compelling evidence that they too can get through the trauma and
   perhaps become long-term survivors of breast cancer.
   In addition to providing emotional support, peer counselors often facilitate patients’
   interactions with health care professionals. Whereas patients often find medical
   personnel to be rushed and intimidating, they find peer counselors to be relaxed and
   supportive. Peer counselors can assist patients prepare lists of questions to ask their
   heath care team, and role play discussions the patient may want to engage in. They
   can also review and further explain information the patient may have received but
   not fully understood. Additionally, during treatment peer counselors can check in
   with patients to provide emotional support, provide suggestions for dealing with
   minor inconveniences, and direct patients to appropriate professionals when the
   issues are more significant.
   I-SPY 2 Partnership with the Breast Cancer Network of Strength (previously Y-
   ME National Breast Cancer Organization): I –SPY 2 has developed a partnership with
   Breast Cancer Network of Strength (NOS) to provide peer support to patients. The NOS was
   founded as Y-ME over thirty years ago by two breast cancer patients in to provide peer
   support and fellowship to breast cancer patients. It is a non-profit organization
   whose mission is: “to ensure, through information, empowerment and peer
   support, that no one faces breast cancer alone.” In 1989 a 24x7 hotline (1-800-
   221-2141) was made available to anyone touched by or concerned about breast
   cancer or breast health. The hotline is staffed entirely by trained and certified peer
   counselors who are breast cancer survivors. Since 1989, a Spanish hotline,
   men’s match program, and interpretation services in over 150 languages have
   been added. You can find out more information about NOS services and/or order
   brochures for your patients at .

   A small group of NOS counselors have received additional training about I-SPY2.
   Thus, if a patient requests a counselor familiar with I-SPY2, they will be directed to

   Following is the procedure that should be used to make patients aware of the
   availability of NOS peer counselors:
      1. If a patient is considering participating in I-SPY 2, inform her of the availability
         of peer counseling through Network of Strength. To speak to a counselor, she
         should call; 800-221-2141. She can talk to any counselor who answers the
         phone to receive peer support to discuss her diagnosis, treatment concerns
         and general information about the pros and cons about participating in a
         clinical trial. This service is available 24x7 to anyone, regardless of whether
         they are considering in I-SPY 2.

            In addition, if approved by your local IRB, you may suggest you’re your
            patients specifically request that an I-SPY 2 trained counselor call them to

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                     Patient Support for I-SPY 2 Clinical Trial

            discuss the trial. This message will be passed along to an I-SPY 2 trained
            counselor who will return the call within 48 hours.

      2. Once a patient has signed a treatment consent, you should explain the
         potential advantages of talking to a peer counselor (see above), and provide
         her with the “NOS Counselor Request Self Mailer” (see
         attached). She can, at her convenience, compete and mail
         the form requesting a peer counselor who will call within
         48 hours of receiving the assignment (probably about a
         week after the request is mailed). Copies will be provided
         during the Site Initiation Visit, and can be reordered from
         Sonia H. Pearson-White, Ph.D: The Biomarkers Consortium; FNIH, 301-435-

            If they choose to complete and return it a
            NOS counselor will be assigned to them and
            will call them approximately five times during their treatment.
            Patients who do not choose to have assigned counselors may
            still call the hotline when and if they choose and speak to an I-SPY2 trained
            counselor. The goals of providing peer support to I-SPY2 participants are to:

               Provide participants with an opportunity to discuss their diagnosis and
                treatment issues with trained peer counselors to validate emotions and
                provide support for dealing with the rigors of receiving breast cancer
                treatment as well as to discuss issues the patient may have about the trial
               Help patient understand and anticipate upcoming aspects of their
               Encourage patients to comply with trial requirements and raise concerns
                with their health care provider

3. Identifying Alternative Clinical Trials: There are two situations in which patients
   who have consented to participate in I-SPY 2 may seek additional trials:
           If a patient has signed a Screening Consent and is found to be ineligible for I-
            SPY 2
           If a patient has signed a Treatment Consent, has completed treatment and
            surgery, and has not achieved a pathological complete response (pCR).
   In both of these situations, we recommend that you explain both verbally and in
   writing, their situation, including the option for their participating in a different clinical.
   Further, we recommend that you identify relevant trials that may be available at your
   site. You may also want to become familiar with and recommend to
   your patients the website . This site
   allows patients to input their specific information and it provides a
   short list with brief description of breast cancer clinical trials for
   which the patient is likely to be eligible.

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