3CTN Patient Recruitment Update: Strong Finish to Year 2
The Coordinating Centre is pleased to report that Q4 Network recruitment reports have been compiled, and these results demonstrate a continuation of the upward trend seen in the earlier quarters of Year 2. While it is true that the aspirational Network recruitment target of a 25 per cent increase was not met in Year 2, it is safe to say if this upward trajectory continues, it paints a promising picture for Year 3 results.
Year 1 to Year 2 Comparisons
When comparing the Network recruitment performance for Year 1 and 2 (see Table 1), it is clear that an upward trend is being established across most sites. For example, in Year 1 only 21 Network sites qualified for per case funding (PCF) payments (i.e., exceeded their baseline recruitment), while in Year 2 that number has increased significantly to 32 qualifying sites. The addition of these 11 sites means that nearly 50 per cent of 3CTN sites will receive PCF for Year 2 performance. Although the entire Network recruitment did not meet the targeted 25 per cent increase, it is promising to note that 13 sites in the Network met or exceeded this goal and 3CTN is hopeful more sites will see a strong performance in Year 3.
Table 1. Total Patient across the Network in Year 1 & 2
*“Year 1” is recruitment performance over a 6 month period (Oct 2014 – Mar 2015), as the Network start was delayed due to contract execution.
What is Promising in Year 3?
Network sites should be optimistic this upward trajectory will continue, and 3CTN will have robust patient recruitment in Year 3. March 2016 marked the launch of the much-anticipated “Ask Me” campaign, which has been adopted enthusiastically by almost all 3CTN sites. As the campaign launch activities were ongoing in April/May, it is very possible this campaign will help bolster patient recruitment numbers in the coming reporting cycle(s). Additionally, sites have been collaborating, and working together more effectively than ever before, as illustrated by 3CTN’s Recruitment Workshop (March 2016) and the follow up Webinars (May 2016). These events have been aimed at helping sites understand recruitment local challenges and learn about tools and best practices they can implement to overcome these challenges. Stay tuned for details of another Recruitment Workshop in the fall, which will be held in conjunction with the November Annual 3CTN Stakeholders Meeting. (See Key Dates).
Windsor Regional Hospital’s Exciting PPI ICTD Activities
On International Clinical Trials Day (ICTD), Windsor Regional Hospital organized an interactive public education booth, which included Patients and Public Involvement (PPI) by providing brochures from the Ask Me Campaign, participation in a knowledge testing quiz board about clinical trials, as well as leveraging the Ask Me Ambassador role to help answer the questions of prospective trial patients.
The Ask Me Ambassador is a great example of PPI, which entails a Lay Representative who can provide the patient perspective to the Ask Me Campaign. The staff at Windsor Regional Hospital chose to approach Nicole MacFarlane, breast cancer clinical trial participant, to fill this role for ICTD. Krista Naccarato, one of the event organizers, said that Nicole was chosen because she is a bright and motivated trial participant who enthusiastically expressed interest in contributing more to the cancer centre. Before participating, Nicole was given training about the Ask Me Campaign, using training slides available on the 3CTN website. During the ICTD events, Nicole had the opportunity to share her own clinical trial experiences, provide information about trial participation to new patients and generally generate interest about clinical trials. Krista said that, “It was a great experience which made Nicole feel empowered and helpful for being able to give the patient perspective.” Krista felt that having an Ask Me Ambassador made their booth more approachable for new patients, and they were able to really engage the other patients and the public. Some common questions such as, “Are Clinical Trials for everyone, or just certain patients?”, and “What trials do we have here, and how do I know if there’s one for me?” were successfully answered by the Ask Me Ambassador.
The Ask Me Ambassador role, as part of the Ask Me campaign, continues to be a great tool for sites to leverage PPI, and to raise awareness about clinical trials. Ask Me Ambassadors are an effective way to provide the patient perspective, and act as an approachable source of information for new patients. 3CTN wishes to congratulate the Windsor Regional Hospital staff for making great use of the Ask Me campaign tools.
International Clinical Trials Day booth at the Windsor Regional Hospital. (From left to right) Nicole MacFarlane and Krista Naccarato.
Recruitment Tool Highlight: The 3CTN Dashboard Template
The Dashboard Template is one of a number of recruitment tools made available by 3CTN that allows for a quick and easy way to capture and present clinical trial departmental productivity data. This tool can help create charts and graphs that are generated automatically for the user, and can be particularly helpful to track screening and recruitment practices as it assists sites by generating custom graphics or departmental newsletters.
The PEI Cancer Treatment Centre has recently started using the Dashboard Template to create a custom informative bulletin board to keep staff informed. Paulette MacCaull, the Clinical Trials Coordinator at the PEI Cancer Treatment Centre, has adopted a strategy of creating a monthly bulletin and, along with her contact information, posts local trial activity updates in one of the main hallways at the centre. The main aim of this bulletin board is to raise interest about local trials in hopes of increasing the discussion about clinical trials and attracting perspective patients to learn more about the types of trials being run at the PEI Cancer Treatment Centre, and get involved. Paulette said, “I love using Dashboard, because it is so easy to use.” Paulette also commented that a positive feature is that this template can be customized specifically for the needs of her site, and in this way generate useful graphics pertaining to the number of trials currently open, the number of trials that are opening soon, as well as the trials that have recently closed to recruitment.
Promoting clinical trials, among both the general public as well as local physicians and staff, is a key factor for successful patient recruitment. The 3CTN Dashboard Template is a great tool to generate the local trial information and graphs, and it is exciting to see sites and coordinators, like Paulette at the PEI Cancer Treatment Centre, making excellent use of these recruitment resources. Aside from the Dashboard Template, sites staff may wish to reference the “Recruitment Best Practices Inventory” for all the tools that are available to help sites boost local patient recruitment.
Feature Trial:
Title: Reduction to Preventive Doses of Enoxaparin after 3 to 6 Months of Treatment with Blood Thinners for Cancer-associated Blood Clots (STEP-CAT) Sponsor: Dr. Vicky Tagalakis NCT#: NCT02752607 Significance: Cancer patients are at risk for blood clots in the leg (termed deep vein thrombosis (DVT)) or the lungs (termed pulmonary embolism (PE)). The current standard of care for the treatment of blood clots in cancer patients is full dose blood thinners, specifically full dose low molecular weight heparin (LMWH) for at least 3-6 months. The aim of treatment is to prevent new blood clots from forming. There is little data to guide physicians on treatment of blood clots beyond 3-6 months. As a result, clinical practices vary widely including continuing full dose LMWH indefinitely. However, risk of bleeding with full dose blood thinners is a concern to many physicians contemplating extending full dose LMWH therapy. We aim to determine if reducing the dose of LMWH to preventative doses after 3-6 months of full dose therapy may help prevent recurrence of DVT and/or PE while minimizing the risk of bleeding associated with full dose blood thinners. Sites open to recruitment:
Jewish General Hospital
St. Mary’s Hospital, Montreal
Sites opening by Fall 2016:
Hôpital du Sacré-Cœur de Montréal
Hôpital Notre Dame, Montréal
McGill University Health Centre (Glen Campus), Montreal
The Ottawa Research Institute, Ottawa
London Health Science Centre, London
Queen Elizabeth II Health Sciences Centre, Halifax
Open to Additional Canadian Sites: No Current Number Enrolled: 0 Target Recruitment: 150
What's new with EDGE?
Recent progress updates are as follows:
3CTN CC conducted an administrative training on June 15-17, 2016 with the sites that have signed the agreements;
The Ottawa Hospital Cancer Centre and British Columbia Cancer Agency are rolling out EDGE to more research groups within their organizations;
Monthly teleconference with the Super User groups to review the data fields and implementation progress;
3CTN CC is working closely with EDGE UK for problem solving and further development of the system to meet the needs of Canadian sites.
