Abstract No. 
2010 San Antonio Breast Cancer Symposium
December 8-12

I-SPY 2 Clinical Trial: Advocate Involvement in Protocol, Informed Consent and Patient Support Materials Development

Perlmutter J, Frank E, LeStage B, Esserman L

Background: I-SPY 2 is an innovative collaboration to assess 8-12 investigational agents and numerous biomarkers in an adaptive, neoadjuvant clinical trial for patients with locally advanced breast cancer and a high likelihood of recurrence. The first site opened in March 2010, and the trial will eventually open in up to 20 sites and enroll 800 patients. Helping patients understand complex clinical trials and make informed decisions about participating in them continues to be a challenge. In the interest of meeting regulatory requirements and protecting participating institutions, informed consent documents often confuse potential patients rather than inform them. I-SPY 2 investigators engaged advocates to ensure that informed consent documents were as patient friendly as possible, and to provide supplementary materials to assist patients obtain the information a way that meets their individual learning styles and information needs. Methods: A network of over 170 advocates from around the US have been informed about the I-SPY 2 trial through presentations at SABCS, webinars, a website and monthly email updates. About 25 of these advocates, including novice and experienced advocates, provided input into the protocol, informed consent documents and/or patient support materials. A virtual process (email and teleconferences) was used to plan, develop and finalize patient support materials and to review multiple versions of all documents. A survey to assess this collaboration was conducted once the trial launched. It was distributed to 25 advocates and 8 staff/investigators. This survey captured: 1) key contributions made by the advocates; 2) amount of time spent on various activities; and 3) perceptions about success of the process.

Discussion: Seventeen advocates responses were received, with nine of the seventeen involved in each of the three components—protocol, informed consent, and patient support materials. A majority of the advocates spent between 5 and 9 hours reviewing documents plus between 2 and 9 hours on teleconferences. Both advocates and staff believed that a majority of advocates’ suggestions were incorporated into the final material. However, several of the advocate recommendations were rejected by IRBs, although concerns varied by site. Both investigators and advocates felt the process was a successful collaboration that will improve patient experiences and are likely to improve accrual and compliance. In addition to changing the documents themselves, advocate suggestions led to several changes in the trial procedures. For example, the trial uses a two stage consent process—one to obtain tissue for screening and randomization, and a second to enroll in the treatment phase of the trial. Also, procedures have been defined for collecting data about specific reasons patients decline to participate, and informing patients who are found ineligible for the trial and when investigational agents are removed from the trial. Details from the survey provide information about: 1) the types of contributions re likely to result from involving advocates; and 2) how to structure the collaboration to maximize satisfaction and contribution. Future research will assess patients reactions to the materials developed for I-SPY 2.

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