Abstract B66: Delaware/Christiana Care Oncology patient advocates for clinical trials
Authors: Hamroun Leila 
Published: October 2015

In 2008, the American Society of Clinical Oncology (ASCO) issued a “Statement of the Characteristics and Attributes of Exemplary Clinical Trial Sites” (Zon, Meropol, Catalano & Schilsky, 2008). The statement served to affirm the basic standards for conducting oncology research and the characteristics of exemplary clinical research sites. Minimum requirements and exemplary attributes were identified based upon literature review, regulatory guidelines and a consensus upon community and academic researchers. Performance goal recommendations to assist in the development of high quality-research programs were developed to exceed the International Conference on Harmonisation (ICH) Good Clinical Practice Guidelines (GCP) guidelines. Attributes included: diversification of clinical trial mix, high accrual activity, participation in the trial development process, maintenance of high educational standards, quality assurance, multidisciplinary involvement in the clinical trial process, and promotion of clinical trial awareness.

Christiana Care Health Services (CCHS), Helen F. Graham Cancer Center & Research Institute (HFGCCRI) located in Delaware, adopted the ASCO recommendations to assess the characteristics of their research program and determined there was an opportunity to strengthen participation in the clinical trial process and clinical trial awareness by developing an oncology patient advocacy committee. Although CCHS had been participating in federally funded oncology research for over 50 years, a clinical trial patient advocacy committee had never been formally convened. At that time an organizational assessment of the standards indicated that “Clinical Trial Awareness” was a value-added attribute that if enhanced, may contribute to improved accrual and assist in maximizing the opportunities for patients and research staff to participate in the clinical trials process.

As a result of these findings, “The Oncology Patient Advocate for Clinical Trials Committee” (OPACT) was organized with a goal towards enhancing awareness and support for clinical trials. Members include individuals who have participated in the oncology clinical trial process and those that are involved in patient advocacy within our community. The Helen F. Graham Cancer Center & Research Institute's, Cancer Research Department has spearheaded this program under the leadership of Stephen Grubbs, M.D., Principal Investigator of the National Cancer Institute (NCI) designated Community Clinical Oncology Program (CCOP), now know at the National Cancer Institute Community Oncology Program (NCORP).

Objectives: Oncology Patient Advocates for Clinical Trials (OPACT) is a group of cancer survivors who have participated in clinical trials and seek to help other individuals who may be considering clinical trial participation. They build bridges between patients, physicians, nurses and others who provide care to cancer patients considering participation in a clinical trial. OPACT enhances ways to increase awareness of clinical trials by educating patients and our community members regarding what a clinical trial is and the importance of a clinical trial participation. They also aim to dispel myths concerning clinical trial participation. Other objectives include:

Limiting/reducing the overwhelming feelings in the decision making process, by connecting prospective clinical trial participants with survivors who have participated in clinical trials so patients can make informed decisions regarding participation.Develop outreach projects to provide education within the community.Involve patient advocates proactively in clinical trial process, including engagement with protocol development, protocol review, ideas for enhancing clinical trial enrollment and providing the patient perspective to researchers designing clinical trials.Gain feedback for how to provide clinical trial results to former clinical trial participants once studies are complete.Identify barriers to clinical trial enrollment and opportunities to remove those barriers.Target opportunities to increase diversity in clinical trial participation including racial and ethnic minorities and the elderly populations.Garner ideas for the recognition of clinical trial participants, such as through an annual celebration.

Results: The OPACT committee was convened and held its inaugural meeting in August 2011. To date, the committee has:

Participated in educational programs regarding the clinical trial process and Institutional Review Board requirements to increase their knowledge about the clinical trial process.Composed a Patient Advocacy brochure, “OPACT: Oncology Patient Advocates for Clinical Trials – Building a Bridge of Understanding for Clinical Trials,” that is provided to patients, families and the community.Developed a logo for the OPACT committee.Advises individuals considering clinical trial participation about process and experienced.Contributed towards the determination of clinical trial activation by assessing the complexity of clinical trial required psycho/social testing.Engaged with the HFGCCRI Community Health Outreach & Education team members to participate in community events providing clinical trial education.Provided presentations and lectures at community educational programs.Convened an annual “Hero's Ceremony” recognizing clinical trial participants and physician clinical trial champions.Became ambassadors for reviewing and approving clinical trial outcome summary reports that are provided to protocol participants.

Zon, R., Meropol, N. J., Catalano, R. B., Schilsky, R., L., (2008). American Society of Clinical Oncology Statement on Minimum Standards and Exemplary Attributes of Clinical Trial Sites. Journal of Clinical Oncology, 28(15), 2562-2567.

Citation Format: Leila Hamroun. Delaware/Christiana Care Oncology patient advocates for clinical trials. [abstract]. In: Proceedings of the Seventh AACR Conference on The Science of Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; Nov 9-12, 2014; San Antonio, TX. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2015;24(10 Suppl):Abstract nr B66.