The Coordinating Centre is excited to announce the Network is on track to exceed its Year 3 target of a 37.5 per cent increase in patient recruitment from baseline. As of the third quarter 2016/17, 24 sites will receive per case funding with an additional 10 sites on track to receive per case funding for exceeding their baseline by end of fiscal year.
The first three quarters of Year 3 have been very successful. An additional 1182 patients were recruited compared to the same three quarters a year ago. Consequently, average quarterly recruitment has been steadily on the rise since 3CTN started collecting recruitment information in 2014. Since 2014/15 the Network has almost doubled its average quarterly recruitment (Table 1). The Coordinating Centre anticipates the Network will finish strong in Year 3, and it is well underway to increasing recruitment by 50 per cent across the Network by the end of Year 4.
Figure 1. Network recruitment from Year 1 (2014/15) to Year 3 (2016/17) Quarter 3
Year
Average Quarterly Recruitment
2014/15
515
2015/16
665
2016/17
1021
Table 1. Average quarterly recruitment per year from 2014/15 to 2016/17
Coming Soon! A new tool for 3CTN Patient Recruitment
As part of the 3CTN Recruitment Workshop in November 2016, the 3CTN CC invited the Family Decision Services team from the Children’s Hospital of Eastern Ontario (CHEO) in Ottawa to join in and present some of their work on shared decision making practices for patients and families in a healthcare setting. Often, complex healthcare decisions can be overwhelming for patients and their families, and healthcare professionals don’t always have the knowledge and skills they need to assist them in the decision making process. CHEO’s Family Decision Services offers training and resources for healthcare professionals to help them engage patients and families better in decisions that affect their health and is there to directly support patients and families when facing challenging healthcare decisions.
Based on interest from Network sites in a decision making tool called a “decision aid” for site staff to have a conversation with patients who are considering participation in a cancer clinical trial, 3CTN struck a formal collaboration with Family Decision Services, and started a 3CTN working group to develop the tool. The 3CTN working group had representation from many stakeholders, including patients, family members, site staff, ethics staff and the CHEO team. The addition of the “patient voice” to the working group was particularly rewarding for Allyson Shephard, the program nurse manager from CHEO as she stated “I really loved the insight provided by the Lay Representatives in the group”. Gretta Hutton was one of the Lay Representatives involved in the tool’s development and commented “I wish there had been a tool like this to focus the conversation with my family when faced with deciding between standard of care treatment or to participate in a clinical trial. There were so many factors to consider and use of a tool like this one would have helped clarify my thoughts and feelings about participating.”
Now, after a number of months of discussions and progress made working from a pre-existing, generic “decision aid”, known as the Ottawa Family Decision Guide (OFDG), the working group is almost ready to release this exciting new tool to all Network sites. Allyson also remarked that “our group at CHEO welcomed the opportunity to collaborate on this tool; we really think it has the potential to help site staff talk to patients and families about making the best decision for them regarding whether or not to participate in a clinical trial as a treatment option”. The final tool, dubbed the 3CTN-OFDG, will undergo a “soft launch” at four Network sites this month. Following any feedback from these initial sites, the working group will make the necessary modifications and the tool will be released to the full Network later this spring. The 3CTN CC is excited to provide yet another tool to the member sites, in an effort to bolster patient recruitment to academic cancer trials across the county.
PPI in Focus
No longer a notion, Patient and Public Involvement (PPI) has become an integral part of the 3CTN Network, helping to improve the clinical trials landscape across Canada. Involvement of PPI is dependent on many variables and looks very different from one trial centre to another. Factors such as population, size of site and perceived value, just to name a few, can affect the outcome of success. One factor that ties the “concept” of successful PPI together is that a very high percentage of trial centres across Canada have some level of PPI embedded within their organization. At the time of the 18-month 3CTN evaluation of the Scientific Advisory Board (SAB), the Coordinating Centre (CC) circulated some questions, as part of it reporting requirements, to collect information about the extent of PPI implementation across all centres. With the 36-month SAB evaluation upon us in June we wish to collect similar information to be able to measure our progress. The questions will be circulated to you as part Schedule G of the Q4 reporting requirements, to help reduce the number of CC emails. Please ensure completion of these questions and return it to the CC as part of your Q4 reporting.
An excellent article about how PPI can work is featured in a video by CTV, about the Ask Me Campaign in London, Ontario!
EDGE Tips
User attributes – Contact Management
EDGE has the ability to record information about a user such as employee number, manager name/telephone number, an alternative email address, and multiple sites a user is working with. This information can be built by local admin users within the Entities section under the Library. A user will then be able to complete the rest of the information under his or her user profile. The user information is also reportable. The site can consider this functionality to enhance their contact management.
PALLAS: PALbociclib CoLlaborative Adjuvant Study:
A randomized Phase III trial of Palbociclib with standard adjuvant endocrine therapy versus standard adjuvant endocrine therapy alone for hormone receptor positive (HR+) / human epidermal growth factor receptor 2 (HER2)-negative early breast cancer.
Sponsor: IND Sponsor (US): Alliance Foundation Trials, non-US Sponsor: ABCSG, Regulatory Sponsor in Canada: Canadian Cancer Trials Group
Significance: Palbociclib is a CDK4/6 inhibitor that has been shown to improve progression-free survival by 10 months (PALOMA-2) in patients with metastatic breast cancer. Given these encouraging results, the molecule is being tested as an adjuvant therapy in patients with hormone receptor positive and HER2 negative stage II or stage III breast cancer. It is hoped that this will decrease the development of metastatic disease in this population where the risk of relapse is present for over 10 years.
Site participation:
# of sites open: 0 in Canada; 94 activated sites in other non-US couintries.
# of sites pending: 20 in Canada
Open to additional sites: No
Target recruitment and how may already recruited? Total recruitment to date is 951 patients. Target accrual is 4600 patients.
Study duration: This study already opened to recruitment in October 2015 and is anticipated to remain open to recruitment to October 2018.
Site Job Positings:
The 3CTN Pulse Newsletter will now feature site job opportunities. Please email info@3ctn.ca if you would like your posting to be featured in our next newsletter.
Announcements:
International Clinical Trials Day is fast approaching! If you require Ask Me Campaign materials for your site, to be used on International Clinical Trials Day, please contact us at info@3ctn.ca to request materials.
Moving forward, the 3CTN Newsletter will be changing to quarterly releases. We look forward to sharing more exciting Network news next quarter. Watch for an announcement this summer about the next newsletter.
Key Dates:
April 3, 2017 – 3CTN Portfolio Committee Meeting
April 5, 2017 – SAB 36-month E-Review submission
April 10, 2017 – Lay Rep. Advisory Committee Meeting
April 11, 2017 – NRCC-NCC-NACC Communications Meeting
June 22, 2017 – SAB 36-month review face-to-face meeting
Contact Us
For inquiries please contact: info@3ctn.ca or call 1-866-678-6427
Canadian Cancer Clinical Trials Network, MaRS Centre, 661 University Ave,
Suite 510 Toronto, Ontario Canada M5G 0A3
