Abstract P2-15-02: The efficacy of recruitment and retention strategies for research subjects in an early phase investigator-initiated breast cancer trial.

Background: One of the biggest challenges faced by investigators is the implementation of effective strategies to improve the recruitment and retention of research participants. This is especially true for investigator-initiated, federally funded (e.g. NIH and DOD), early phase clinical trials that involve the treatment of serious diseases such as metastatic breast cancer (MBC). These studies may face additional barriers to participation since patients have often already undergone maximal treatment and are usually not in a financial position that for allows the travel and lodging necessary to receive further investigative treatment. Moreover, efficacy and toxicology in early phase clinical trials are unknown. Thus, when study budget constraints do not allow monetary incentives to participation, it is difficult to provide motivation for patients to enroll and remain adherent to the protocol requirements. However, many MBC patients are motivated to join clinical trials for altruistic purposes alone, and evidence supports that the researcher-patient relationship may be the most important factor in clinical trial participation. Recognizing that many patients are willing to participate if provided the appropriate resources despite limited monetary incentives, we developed a system to improve patient recruitment and retention to our studies, which are primarily federally funded. We report here on the strategies developed and used by our group to recruit and retain patients in a federally-funded investigator-initiated phase I/II vaccine study in MBC patients. Methods: This study was funded by the NIH/NCI and involved infusion of HER2 specific T cells in HER2+ MBC patients after completing in vivo priming with a HER2 vaccine. It required 11 visits to Seattle, Washington. Working with agencies that offer free services to patients enrolled in clinical trials, a list of available resources was compiled and a visit flowchart with specific information on travel and lodging resources (e.g. Angel Flights and ACS sponsorship), local transportation and entertainment was developed. During screening, patients were given the list of resources and trial information. An email system was used to quickly communicate and follow-up with patients. Eligible patients were given the visit flowchart to help with their planning of study visits. An enrollment packet was provided at the first visit with a calendar to keep track of the visit schedule. Coordination of care between the patient9s primary oncologist and the research staff was maintained throughout the study. Results: 17 of 19 patients enrolled were not from Washington State. Two out-of-state patients withdrew early from the trial for reasons unrelated to disease progression or toxicity; one subject completed 8 visits and enrolled in another study and the other completed 2 visits and discontinued the trial to resume chemotherapy. Conclusion: We have developed a successful system to enroll and retain patients in a trial requiring multiple study visits. Development and implementation of site-specific standard procedures are critical to improve study participation and retention, especially when patients receive no financial benefit. Citation Information: Cancer Res 2012;72(24 Suppl):Abstract nr P2-15-02.