The Brustkrebs-Studien.de website for breast cancer patients: User acceptance of a German internet portal offering information on the disease and treatment options, and a clinical trials matching service

Breast cancer is the most common female malignancy in Germany and worldwide, and its prevalence is predicted to increase [1]. Growing numbers of clinical trials are being conducted to collect the information needed to provide patients with tailored treatments, and the guidelines for certified breast centres in Germany require that 20% of all treated patients be enrolled in clinical trials [2]. However, trial recruitment is difficult, expensive and time-consuming [3]. In the everyday clinical setting, physicians recruit fewer than half of the potentially eligible patients into clinical trials [4]. Major factors preventing patients from participation have been shown to include lack of interest [3, 5], low acceptance of the study treatment, concerns about work-related problems, travel and long treatment periods [6, 7]. Physicians fail to recruit patients due to reservations about clinical trials and negative referral policies at certain centres, and their patients' comorbidities, mental state and disabilities [8, 9]. In addition, the inclusion and exclusion criteria for trials can vary to such an extent that physicians may not have sufficient knowledge to identify eligible patients [10]. On the other hand, 40-50% of cancer patients already resort to the Internet for healthcare information, and this number is likely to increase dramatically over the next few years [4]. As a result of "patient empowerment", patients have come to expect access to reliable, high quality, patient-centred information on their medical condition and all available treatment options.

To meet these demands, the German Society of Senology (DGS) and the Baden-Württemberg Institute for Women's Health (IFG) in 2000 jointly launched the internet portal http://www.brustkrebs-studien.de (BKS) as a not-for-profit service to breast cancer patients and physicians alike [11, 12], offering patients extensive information on the disease, its treatment and study participation, and providing investigators with a registry database for their clinical trials. We here describe how BKS was developed and present the results of the implementation phase as a proof of principle.

Over the past few decades, the concept of tailored treatment for breast cancer has led to an ever-increasing need for clinical studies, but patient enrolment has generally been too slow to meet the demands of valid guidelines. As a result of patient empowerment, the demands for reliable, patient-centred information have also grown. The integration of the patient as an active participant in the decision-making process and a partner requiring comprehensive, up-to-date, correct, comprehensible information reflects the changing patient-physician relationship. The Internet has become a key source for patients who wish to be well informed [25], and it has been identified as a powerful vector in increasing trial recruitment rates [4]. It has also been shown that the knowledge- and data-intensive processes of determining patient eligibility can be facilitated by using computerized systems [26]. Here, we describe how the German Society of Senology (DGS) and the Baden-Württemberg Institute for Women's Health (IFG), in collaboration with patient support and advocacy groups, developed and established a trusted online information and communication platform featuring up-to-date trial protocols and resources for the growing physician and patient community. Similar to the NCI's ClinicalTrials.gov, the BKS portal is an official resource backed by a national specialist medical society and aims to serve patients, doctors and researchers alike.

It is unrealistic to assume that physicians can screen every patient for trial eligibility in view of the vast number of clinical trials available today. A large number of potential participants are therefore lost. It has been suggested that only 2-4% of patients with newly diagnosed cancer participate in clinical trials [27]. Although online trial registries seem to be a preferred solution to this dilemma, trend analysis has indicated that it is unlikely that a single trial database would function worldwide, enabling multiple domain-, funder- or country-specific registers to be created [28].

Over the past few years, we have established the BKS website as a highly frequented breast cancer portal with a total of over 700,000 visitors by the middle of 2010. On average, 46,183 visitors accessed the BKS portal per quarter during the period from 1 October 2005 to 30 June 2010.

The true value of the BKS became apparent in 2009, during which year 143 patients contacted investigators via the website to enquire about trial enrolment and 119 requests for second opinions were submitted via the secure e-messaging service. The benefits of e-messaging have been widely discussed in the literature and include decreased numbers of telephone calls [29], unnecessary clinic visits [29‐31], improved patient care [32], greater efficiency in the exchange of information between physicians and patients [29] and cost savings [33].

The respondents to our online survey showed a high degree of satisfaction with both the design of the portal and the information provided, and also expressed great trust in the information. The great majority of respondents stated that they would recommend the portal to others and continue using it in the future. Patients have been shown to respond positively to portals backed by a national specialist medical society because they are perceived as more trustworthy [34], and this is a likely reason for the success of our portal, which is officially supported by the German Society of Senology (DGS).

By the middle of 2010, the BKS covered a total of 163 current breast cancer trials, which the advisory board had selected as the most important trials. The active scientific BKS community at the time consisted of 189 physicians and investigators. The majority of trials (55%) focused on the use of chemotherapy in recurrent disease. However, the most visited trials were those investigating adjuvant chemotherapy regimens. This is especially relevant since the majority of trials registered with the NCI during our study period were neoadjuvant studies, possibly reflecting the future focus of research in breast cancer trials.

The success of trial registries depends on a number of factors. One of the main issues in the development of the BKS portal was the need for up-to-date information on trial status, which meant that principal investigators had to take responsibility for updating the information on their trials and removing closed trials from the database. To achieve this, the system was equipped with an automated notification and feedback service to encourage commitment on the part of both the support team and the investigators.

Studies suggest that female patients are generally in favour of clinical trials [35, 36], and this is supported by our finding that almost two-thirds of the BKS visitors considered participating in a trial. However, complex trial descriptions and eligibility criteria, the extensive use of medical terminology and expecting patients to determine preferences early on in the registration process act as strong barriers to trial participation [8]. Patients with previous clinical trial experience have fewer concerns than those facing this option for the first time, and recommendations by clinicians play a significant role in their decision [10]. For these reasons, and based on the suggestions of Gillen et al. [22], the emphasis in the development of the BKS portal was placed on patient-friendly versions of trial protocols embedded into relevant patient information and supported by leading breast cancer experts. Our user analysis showed that most patients appreciated being able to search for suitable trials themselves, and that patients relied on the Internet, and not their doctor, for information on trials. To concentrate on patient-friendliness and provide high-quality content was therefore the right approach. To ensure that patients' needs were addressed appropriately, all development work was, and continues to be, conducted in close collaboration with patient support and advocacy organizations, notably "Frauenselbsthilfe nach Krebs" (Women's Self-Help after Cancer) and "Mammazone".

A further trend observed in our analysis is that patients are interested in online personal health records, which is consistent with earlier reports [10]. Although this trend has been known for some years, no approach to patient disease management has been successfully adopted at a national level so far. The BreastCancerTrials.org service [13], however, offers a promising approach. It functions as an online patient breast cancer record combined with a matching service to suitable trials. OnkoLink is a similar portal but is not breast cancer specific [37]. A matching service for trial eligibility based on the US National Cancer Institute's Physician Data Query (PDQ) database was introduced by Ohno-Machado et al. [38]. Not only has it been shown that computer-based, automated screening is superior to physician-based individual screening [39], but also that an online system gives patients more information and more time to decide, and also increases their confidence in their decision-making [40]. Before the BKS portal was initiated, no such approach had been pursued in Germany for breast cancer - a shortcoming that has now been addressed.

One of the limitations of online services for study recruitment in this population is that female breast cancer most frequently occurs after the sixth decade of life, at which age women may be less likely to use online services. Moreover, minorities tend to be underserved with regard to Internet access, especially in rural areas [41]. Clinicians should therefore bear in mind that clinical trial recruitment via the Internet may introduce bias [42]. Thus, potential selection bias represented another limitation to our user analysis. Further limitations included the relatively small sample size, the short period during which the survey was conducted, and that it is unclear whether the participants were representative of the general population, e.g. with regard to age distribution. Despite these limitations, we are confident that the largely very positive answers from the respondents confirmed our approach to launch the BKS portal and that they provided useful information for further enhancements to the service.

Web-based clinical trial portals have great potential as a tool for physicians to manage an increasing number of clinical studies and for patients to access accurate and up-to-date information. Developed by a team physicians and investigators, patient support and advocacy groups and the German Society of Senology, the BKS website already effectively meets the needs of all types of users with regard to data security, privacy and ease of use. A conceivable future refinement of our system will include the creation of pools of eligible patients who have expressed interest in clinical trial participation, undergone preliminary screening and given basic consent. Work is in progress to expand the service by introducing a tool for cross-matching patient demographic and clinical data with trial inclusion and exclusion criteria. Integration of such services into hospital information systems would greatly facilitate preliminary screening and mean that a web-based tool of this kind could be integrated into everyday clinical practice. Most importantly, outcome research is now needed to determine whether such tools actually result in improved recruitment to clinical studies.

We conclude that http://www.brustkrebs-studien.de is an established and trusted interactive platform providing information on breast cancer for patients and physicians alike. With the aim of encouraging participation in clinical trials, it offers the growing community of patients and physicians seeking information on the internet a range of up-to-date resources including expert-written content on the disease, current treatment options and clinical trial protocols. Further studies are needed and being undertaken to assess potential increases in trial enrolment by eligibility matching services.