Recruitment Edition Duration of Trastuzumab with chemotherapy in women with early stage breast cancer: Six months versus Twelve We hope you enjoy this special issue which focuses on recruitment and gives you an inside look at what happens with regards to the trial at Bedford Hospital, Norfolk & Norwich Hospital and Royal Shrewsbury. If you would like to feature in our next edition please contact us. www.warwick.ac.uk/go/persephone The trial opened in October 2007 and since then 149 sites have registered their interest with 148 sites open so thank you to all who helped us to achieve this!! We still need your continuous support to improve accrual. The recruitment target is 4000 patients to be entered by December 2013 so please screen all patients as every single one counts. (each year since the trial opened) We now just need the following to aid the trials success: actively screen all patients and randomise as soon as possible remember patients can be randomised prior to the 10th cycle of Trastuzumab treatment 2008 - Royal Liverpool and Clatterbridge 2009 - Peterborough District Hospital 2010 - Maidstone Hospital 2011 - Norfolk & Norwich 2012 - ?????????? You are making the Persephone trial a success and helping to shape the future of breast cancer treatment The best recruiting sites Addenbrookes are the single site who have randomised the most number of patients to date Wexham Park randomised the 1500th patient! HAMPER WON for randomising the 1500th patient in August 2011!!!! Jayne Litchfield had this to say: Some of the Wexham team are pictured above. Team members include: Alison Sears (RN and Team Leader), RN Jayne Litchfield , RN Catherine Smith, RN Victoria Robinson, RN Ann Jackson, Administrator Juile-Ann Sinclair, Coordinator Nicky Barnes. “I did realise when I randomised this patient that 1500 might be a significant number! I'm so pleased the trial is going well. When we first heard about Persephone we were a little worried about how it might be received, as were the clinicians, but after the first month recruitment really started to take off. We found that the older patients had really started to tire of treatments and so were quite happy if they were randomised into the 6 months arm. Some of the younger patients were worried about taking further time off work so they too were happy if they were drawn the 6 months arm. Above all the patients generally were happy to take part in a trial endeavouring to answer a very important question”. HER2-Negative patients can be randomised into ARTemis: Avastin Randomised Trial with neo-adjuvant chemotherapy for patients with early breast cancer. For more details please contact J.C.Blenkinsop@warwick.ac.uk Page 2 Royal Shrewsbury - Consistently Good Recruiters Royal Shrewsbury Hospital is a busy Oncology centre, who have recruited 19 patients since opening in October 2010 and estimate their acceptance rate for the trial as approaching 62.5%. Here are their “Handy Hints”. The team at Royal Shrewsbury, from left to right: Sr Karen Nicholas, Sr Helen Moore, RN Sunny Kurian-Downer, Dr Sheena Khanduri (PI) and Sr Sally Potts Develop a comprehensive screening log to track potential patients’ journeys. Clearly track when patients have received the Persephone Patient Information Leaflet. Ensure a team member follows the progress of the named patient so they do not slip ‘through the net’. Develop a précis of the Persephone trial and upload this onto the intranet. Ensure all members of the Breast MDM know about the study and have received a copy of the précis. Briefly introduce the Persephone trial to the patient when trastuzumab is first mentioned. Ensure all members of the Breast MDM are sent the Persephone Newsletters, so they are aware of the study progress. Screen all HER2+ve patients prior to clinic and check basic eligibility. Put a starter pack (Persephone Patient Information Leaflet, sample consent form and Macmillan Cancerbackup leaflet on trastuzumab) with patient’s notes prior to clinic, so the clinician seeing the patient is prepared and aware that the patient is potentially eligible. Ensure a member of the Cancer Clinical Trials team is with the patient when the Persephone study is discussed by the clinician Always arrange to see the patient at their first or next trastuzumab to answer any questions they may have about trastuzumab and the Persephone study. Keep the Chemotherapy Day Centre team involved and informed of the progress of the Persephone study. If you have any hints or tips that you’d like to share to help other sites to recruit well, then please let us know A BIG thank you to all of the teams at Royal Shrewsbury, Norfolk & Norwich, Bedford Hospital & Wexham Park for their help with the Persephone trial and with this publication Page 3 NORFOLK & NORWICH Best Recruiting Site in 2011 Norfolk & Norwich Hospital have recruited 39 patients since opening in December 2009 and estimate their acceptance rate for the trial as approaching 54.5%. In 2011 alone, they randomised 23 patients. The PI, Dr Daniel Epurescu and members of his team took time out to answer some of our questions. How many new breast cancer patients were seen last year? 500 approximately What do you think is your % acceptance rate? Of the patients identified as eligible, 20 patients declined the trial, mainly as they preferred to have 12 months trastuzumab. We recruited 24 patients so the acceptance rate is 54.5% How do you identify potential new patients? Mainly through the breast MDT meetings which the Breast Oncologists and clinical trial practitioner attend on a regular basis. The clinicians are very pro-active and will call the research team to see patients in clinic to discuss the trial. The ethos of the clinicians and research team is that the pathway for breast cancer patient care encompasses clinical trials and all patients should be offered the opportunity to take part in such trials. When do you approach patients? During the clinic consultation and after. Usually prior to starting the treatment so that they can enter the trial from day one. How long do you spend with potential trial patients initially? Approximately another half an hour with the trial practitioner after the trial has been initially discussed during the clinic consultation which takes about 20-30 minutes. When do you discuss the trial again? We allow the patients the opportunity to discuss the trial with family members/significant others and give them plenty of time to consider – up to the 9th Cycle in some instances. We encourage patients to ask any questions they may have and we provide them with our contact details and encourage them to contact us with any questions so in the end they can undertake an informed consent. How do you reassure patients? We allow them plenty of time to decide whether they want to go into the trial. If they are concerned about the possibility of 6 months Herceptin, despite our reassurances based on published data, then we would recommend that they do not consent for the trial. We would be unhappy to enter them. ...Here’s what Bedford General Hospital have to say about the trial PI Dr Sarah Smith (centre) RNs Anne Willis (left) & Kathryn Newton (right) “Depending on what chemo regimen the patient is on (we try to start the patient on trastuzumab around the 5th or 6th cycle of chemo), the Consultant will then talk about trastuzumab and say we have a trial running which offers 6 months as opposed to a year. She will explain briefly, not in any great detail that Persephone is happening and will then give them a Patient Information leaflet (PIS). The RNs then follow them up the next time they come in for chemo asking if they’ve had a chance to look over the PIS and if they have any questions. Usually they ask if it’s ok to have 6 months as opposed to a year. We tell them that when the drug was first manufactured there was no clear evidence to say that a year was the right duration but that there has been evidence since from smaller trials to show that actually having less doesn’t make much difference to the outcome. Therefore they are running a larger academic trial to see if this is right, and in fact some trials have shown that even less than 6 months is enough. I also mention that all trials have to go through an ethical committee, and they do have to check that it is safe for patients. A lot of people are very keen to enter. I do go through the side effects of trastuzumab with them – that some people can’t tolerate it and for those people 6 months would be great and, that if they receive 6 months they have fewer visits to the hospital. We give them plenty of time to consider the trial; they have 9 cycles to make up their mind. We tell them not to make a decision now; we’ll come back and talk at their next chemo session. If they are undecided then, we tell them to leave it for now and if they do decide that they want to do it then just let us know, so they don’t feel pressured. I think the biggest problem is when people try to pressurise them. If I do get asked whether I would go on the trial or not I always tell them that I don’t know. I would never try to influence or persuade them, it has to be their decision totally. We do tell them that if they have cold feet half way through the trial they can withdraw, and although no one has, they do feel comforted by that. They also want to give something back. If a patient tells us they would withdraw if they don’t get the arm they want, we would tell them that’s not ethical. I have been asked before what would happen if the Doctor decided they should have more or less cycle’s whist on the trial, and we explain that this would not happen and that the decision would be made before they are offered the trial.” Keep checking the website for updates www.warwick.ac.uk/go/persephone General Trial Information SAEs Please remember to return all CRFs to the Warwick Persephone Trial Office as soon as the form has been completed. Forms are checked for data completeness, discrepancies and abnormal LVEF findings. As part of our central monitoring procedure a reminder for all outstanding data is sent out. In addition, Sites will be contacted via telephone for CRFs which have been requested twice or more already. Changes in Site Staff Please keep the Site Signature Delegation Log updated and ensure Warwick have the correct registration forms for all staff working on the Persephone trial. PI and Co-I CVs All CVs for PI’s and Co-I’s need to be signed and dated within the last two years. Please ensure Warwick have up to date CVs. LVEFs An LVEF schedule is sent to site when each patient is randomised. If an LVEF is not performed at the correct time point, please inform Warwick straight away. www.warwick.ac.uk/go/persephone Data queries From a trial view, an abnormal LVEF finding is considered as a safety issue and therefore it is essential the Persephone Trial Office are made aware of such findings through prompt data return. Repeat LVEFs need to be performed until a recovery LVEF result is obtained. A SAE is any untoward medical occurrence that at any dose results in: • death • initial or prolonged inpatient hospitalisation (excluding hospitalisation for study drug administration) • a life-threatening experience (i.e. immediate risk of dying) • persistent or significant disability/incapacity • congenital anomaly or birth defect Please complete and fax all SAEs Forms to the Cambridge Clinical Trials Centre on 01223 348 071 within 24 hours of becoming aware of the event Persephone-SNPs sub-study - Blood Collection Please can you ensure that trial patients blood samples are being sent to Cambridge. Bloods can be taken at any time point following randomisation. If you need more kits or if you need a list of patients to target at your s i t e , p l e a s e c o n t a c t : Louise.Grybowicz@addenbrookes.nhs.uk Tumour Block Collection Kevin at Cambridge is contacting pathologists at all open sites to request blocks. The blocks will be returned to the pathologist. For more information, please contact: Kevin.Baker@addenbrookes.nhs.uk PERSEPHONE team (For efficiency please address your query to the relevant team member) General Enquiries & Data Management Emma Ogburn Trial Co-ordinator (Warwick) E.Ogburn-Storey@warwick.ac.uk Phone: 0247 615 0492 Shrushma Loi (Wed-Fri) Trial Coordinator (Warwick) S.Loi@warwick.ac.uk Phone: 0247 615 0492 Trial supplies (site files, CRFs etc) Outstanding set-up documents Donna Howe Clinical Trial Administrator (Warwick) D.L.Howe@warwick.ac.uk Phone: 0247 615 0600 Trial supplies (CRFs etc) Data Queries Matthew Dalby Date Input Clerk M.L.Dalby@warwick.ac.uk Phone: 0247 615 1127 Data Input Sharisse Alleyne Date Input Clerk S.Alleyne@warwick.ac.uk Phone: 0247 615 1786 Pharmacovigilance, Pharmacy & Translational Studies Louise Grybowicz – Blood Collection (Cambridge) Louise.Grybowicz@addenbrookes.nhs.uk Phone: 01223 348447 Kevin Baker - Block Collection (Cambridge) Kevin.Baker@addenbrookes.nhs.uk Phone: 01223 348083 Caroline Jevons (Tue & Weds) Recruitment Facilitator (Warwick) C.Jevons@warwick.ac.uk Phone: 0247 615 0990 Site initiations The views and opinions expressed are those of the authors and do not necessarily reflect those of the HTA programme, NIHR, NHS or the Department of Health