Dr and patient CRFThe Kidney Cancer Support Network (KCSN) Patient Champion Programme is a patient-led initiative to build awareness of kidney cancer research and clinical trials, and to provide information, support and encouragement to patients taking part in trials throughout the UK. The project is being run in collaboration with the National Cancer Research Institute (NCRI) Bladder and Renal Cancer Clinical Studies Group.

Patient champions have an keen interest in kidney cancer research and clinical trials, either as patients or carers/family members of a patient on a trial. The role of the patient champion includes:

  • Building awareness of the various renal cancer clinical trials in their local area to raise the profile of kidney cancer research among patients
  • Supporting and encouraging kidney cancer patients to enable them to make an informed decision about clinical trial participation to help improve recruitment and retention of patients
  • Disseminating information to their local kidney cancer patient community via renal/oncology clinics at hospitals, the KCSN forum, the KCSN Facebook page, email and other kidney cancer groups
  • Answering queries from patients and carers in their region about clinical trials
  • Encouraging dialogue between patients/carers and clinicians about clinical trials
  • Being the main point of contact with the urology leads/renal specialists in their local area.

 

Patient champions will become patient experts in kidney cancer research and use this expertise to support others taking part in clinical trials. To enable them to carry out their roles effectively, the patient champions will require training in clinical trial methodology and the regulations surrounding clinical research. This will be achieved through regional training workshops to update the patient champions on the research activities in their regions.

The first two patient champion workshops took place on:Group-workshop

  • Tuesday 31st January 2017 at The Royal Marsden Hospital in London
  • Thursday 2nd February 2017 at The Christie Hospital in Manchester

Information about each workshop can be found in the tabs below, including a brief report of the day, photos and the agenda for each meeting:

Various training materials and clinical research resources have also been developed and can be found in the Clinical Trials Hub on the new KCSN website.

To support the patient champions in their role, and to help inform patients and clinicians of the kidney cancer clinical trials taking place in the UK, KCSN has developed a bespoke clinical trial database containing 129 investigation sites from 23 different clinical trials. Patients are able to search the database for a clinical trial that is suitable for them and located in a hospital near to where they live.

A network of patient champions is being developed to cover the 15 Clinical Research Networks (CRNs) in England. We are also in the process of rolling out the programme to Scotland, Wales and Northern Ireland for the benefit of all UK kidney cancer patients during 2017, and intend to hold further patient champion workshops in Glasgow, Belfast and Cardiff later in the year.

If you are interested in becoming a patient champion for KCSN, and you have some knowledge or first-hand experience of taking part in a clinical trial, please email us or ring us on 01209 890326 for further information and to talk through the programme.

 

The following companies have supported the Patient Champion Programme with an unrestricted grant:

hi_big_e_lrg_pinkpfizer_logo_detailnovartis-logo

unspecified-8We had a fantastic turnout to our first Patient Champion Programme Clinical Trials Workshop, which was held at The Royal Marsden Hospital on Tuesday 31st January 2017. KCSN and Dr James Larkin, consultant medical oncologist and KCSN trustee, jointly hosted the workshop.

Download the agenda for the meeting by clicking on the link below:

Patient champion workshop agenda London FINAL

Rose opened the meeting with some background to the Patient Champion Programme. This meeting is an exploratory meeting to gauge interest in the Patient Champion Programme and to identify patient champions for the South East, South West, East Anglia and London regions. Rose thanked The Big Lottery, Pfizer, and Novartis for their support with the Patient Champion Programme.

The new KCSN website, specifically the Clinical Trials Hub, the clinical trials database, and the Information Hub, was well received by the patients and carers. A couple of suggestions for how to improve the clinical trials database were discussed and will be investigated for inclusion in version 2 of the database. Sharon Kell is responsible for keeping the Clinical Trials Hub and database up-to-date, so if you know of any clinical trials that are not listed on the database, please let Sharon know. Julia Black is an experienced advocate for access to treatments, and can help patients who are trying to access treatments through the complicated processes for Individual Funding Requests and the Cancer Drugs Fund.


image005Dr James Larkin
gave an overview of kidney cancer research and the drug development process, including the different phases of clinical trials. He also touched upon academic versus pharmaceutical trials, the former requiring public funding. Quality of life is not often measured in pharmaceutical clinical trials, unless requested by the regulators, such as NICE.

There was some discussion regarding the usefulness of statistics in clinical trials, and how data from trials relates to the individual. The importance of real world data (i.e. data collected when a treatment is used in the clinic outside a clinical trial, such as collected by the KCSN patient registry) for health technology appraisals, and how clinical trial populations relate to the general population was also discussed.

Dr Larkin touched upon the heterogeneity of kidney tumours and the difficulty unspecified-10identifying biomarkers for kidney cancer. Trials involving biopsies can help to gain an understanding of why some drugs work for some patients and not others. The Royal Marsden is involved with the PEACE study, a Cancer Research UK study, where a patient gives consent in life for multiple tumour samples to be taken after death. It is hoped this study will give an insight into how best to treat the cancer.

Dr Larkin concluded by talking about kidney cancer research priorities as being:

 

unspecified-11Maggie Wilcox from Independent Cancer Patient Voice (ICPV) talked about the work of ICPV to improve patient involvement in research. ICPV’s aim is to improve existing treatments for every cancer patient, and to develop new treatments by bringing the patients’ voice into clinical research. This is accomplished by educating, supporting and mentoring patients so that they can have an equal voice with clinicians and researchers, and through acting as patient advocates in clinical research. Download a copy of Maggie’s presentation here:

Patient Champion Workshop – Maggie Wilcox

Members of ICPV are informed and committed patient advocates who play an increasingly effective role in educating both potential patients and professional staff as to the benefits of patient involvement in clinical trials and research. They have an active online discussion group where members can exchange views and review research papers, and they organise study days on the science/biology/genetics of cancer and the development of new treatments with the full support of the NCRI Breast Clinical Study Group.

Maggie mentioned the useMydata initiative for patients who want their data to be used for research, the tissue access committee, and INVOLVE for information about patient engagement in research. Their involvement in research is active, not passive, and they get involved in the very early stages of the research process.

 

Katie Barrett was diagnosed with stage 3 kidney cancer in June 2010, and had her kidney removed the following month. She actively investigated what trials were available, and was lucky enough to see Professor Eisen at Addenbrooke’s Hospital in Cambridge, and to be offered the opportunity to participate in the SORCE trial. At this time her survival was given as just 20 percent. Following 1 year of sorafenib and 2 years placebo treatment she is still clear, back at work full time and leading an extremely active life!

Katie talked about the importance of patient compliance in clinical trials for the endunspecified-12 results; if patients are not compliant with the protocol, the overall outcome of the trial could be compromised. Support from other patients with clinical trial experience could help patients stay on drug when the going gets tough. Patients also need to be honest about side effects. Some patients are not honest about side effects because they were worried about being taken off the drug; however, this will rarely be the case. The dose can be reduced or a ‘drug holiday’ given to help alleviate side effects.

Katie feels it is better to be doing something, rather than sitting back and waiting for the next set of results. In a clinical trial, you are followed-up regularly; this gives patients a ‘comfort blanket’ because the cancer is being regularly monitored. Finally, Katie mentioned that patients need to have feedback of trial results, even years after the trial since some trials can take years to complete.

 

Lynda Pyle has been a cancer nurse for 40 years, and has specialised in renal cancer for the last 20 years of her career. When she first starting working with kidney cancer patients, the only treatment for advanced kidney cancer was the cytokines, interleukin 2 and interferon. Response rates to these treatments were poor and varied. Over the years, she has seen hundreds of kidney cancer patients in clinical trials, most of whom have had metastatic spread of their cancer.

For academic trials, she has input into protocol design and patient information leaflets (PILs). She feels strongly that too much irrelevant information is given in PILs these days, which are far too long and complicated (25-30 pages!) and could be off-putting to patients. Patients come to a clinical trial with high expectations, but often the trial is not suitable for them; part of Lynda’s role is managing expectations of patients.

Phase I trials involve daily visits to the hospital and require a lot of commitment on behalf of the patients. There are a number of invasive tests, such as biopsies and blood tests, and patient come from all over the country. The research nurse makes sure trials are safe for the patients. Patients may fail screening for entry into a trial e.g., tumour not big enough, can’t perform a biopsy, uncontrolled diabetes, concomitant disease etc. and patients get very disappointed. The research nurse supports them through this disappointment, but often the patient can’t enter the trial due to safety reasons – safety is paramount in clinical trials.

The research nurse ensures there is someone to contact most of the time, which is reassuring to patients and their families.

Patients don’t fully report side effects because they are worried they might be taken off the investigational drug. In clinical trials, treatment is only stopped if the side effects are very serious/life threatening. Patients might be taken off drug for a while and restarted on lower dose. Fatigue is a big concern for cancer patients on clinical trials. It is difficult to treat fatigue, but exercise can help. Patients have a duty to report everything to whoever is running the study. A lot of clinical decisions are made on the results of trials and the data needs to be collected. Patients tend to tell the research nurse more than the doctor running the study!

 

unspecified-13Dr Natalie Pattison is a senior clinical nursing research fellow at The Royal Marsden, who works part of her time for the National Institute for Health Research (NIHR), the main funding body for NHS research, and the Biomedical research Centre at The Royal Marsden (one of only 2 such centres in the UK, the other being at The Christie in Manchester).

There is currently a political commitment to support the life-sciences industry and clinical research is embedded in all aspects of care through the Health and Social Care Act 2012 and the NHS Constitution 2013.

Natalie talked about the NIHR and the 15 Clinical Research Networks (CRN) throughout England, and the national coordinating centre, which aim to make clinical trials more accessible. Each CRN supports clinical studies to make sure they are appropriately resourced with people and equipment to enable the researchers to carry out trial activities.

CRNs support research by:

  • Funding research support posts in the NHS and providing training, so that researchers have access to experienced front-line staff, who can carry out the additional practical activities required
  • Providing funding to meet the costs of using facilities, such as scanners and X-rays that are needed
  • Helping identify and recruit patients, so that researchers can be confident of completing the study on time, and on target

 

Each CRN delivers research across 30 different clinical specialties. CRNs improve the health of the nation through health research and research is part of overall healthcare in the NHS. Innovation adds value to NHS services, and helps to develop partnerships and engage with patients and other stakeholders. Funding decisions are regional across each CRN for a particular trial. Funding comes from the NIHR.

 

The current focus for CRNs is on dementia and neurodegeneration, and funding is being directed to clinical trials in these areas.

 

The main objective of the CRNs is to increase patient participation in NIHR CRN unspecified-15studies. Other objectives include:

  • Increase the proportion of studies recruiting on time and target
  • Increase the number of commercial studies delivered through the NIHR CRNs
  • Reduce set-up time of studies
  • Reduce time to recruit first patient into NIHR CRN studies
  • Increase NHS participation in NIHR CRN studies

 

About two-thirds of NIHR CRN studies are non-commercial (academic) and over 600,000 patients are recruited into NIHR CRN studies each year.

 

NIHR CRN are running the following campaigns to promote clinical research and raise awareness to patients and the public nationally and locally:

  • OK to ask (about clinical trials)
  • Spotlight on mental health and Spotlight on obesity to increase engagement
  • STarT Back campaign – to get people back to work with back pain
  • Text Stop for smoking cessation
  • Pneumonococcal vaccine campaign.

 

Natalie briefly touched upon the annual Research Activity League Table, which shows the extent research activity across all NHS trusts in England. The table is promoted nationally and locally through patient interviews and case studies.

The NIHR Patient and Public Involvement and Engagement (PPIE) programme five year goals are:

  • Talk about research in the NHS
  • Make it easy for people to participate
  • Reach out and engage communities
  • Connect with the public, healthcare professionals and partners
  • Patient focused research

 

More information about the PPIE programme, including patient experience surveys, patient-centred communication project, and the Patient Research Ambassador Initiative (PRAI), can be found in Natalie’s presentation here:

Patient Champion Workshop – Natalie Pattison

 

unspecified-14Dr James Larkin and Rose Woodward concluded the workshop with an introduction to the work of the National Cancer Research Institute (NCRI) Clinical Study Groups. The aim of the NCRI is to improve cancer research in the UK. Clinical Study Groups bring together oncologists, surgeons, statisticians, and consumers (patients) concentrating on trials for the treatment of one particular cancer type. They develop research studies that compliment industry research. There should be opportunities for people to access clinical trials in every part of the network. The advent of social media has led the transformation of cancer treatment driven by the patient voice.

There are pockets of interest among clinicians around country, and everyone should have the opportunity to go into a trial. Lack of resources and investigator interest are a couple of barriers to trial participation.

Within each of the 15 CRNs there is a specialty lead for urology. Patient champions need to identify the urology lead for their local CRN and liaise with them over clinical trial/research opportunities. We need to make a noise to raise the profile of kidney cancer clinical trials within the CRNs. The names of the specialty leads are published on the NIHR website under each CRN.

The Bladder and Renal Cancer Clinical Study Group are about to embark on a new trial called RAMPART, follow-up to SORCE using immunotherapy adjuvant therapy. The study is planned to open in the third/forth quarter 2017. It is an academic study requiring 2,000 patients with intermediate/high risk of recurrence who are given immunotherapy adjuvant therapy within 12 weeks after nephrectomy. Patients need to be identified before they have surgery to ensure the 12-week window is not missed. Patients could be empowered to make surgeons/oncologists aware of adjuvant trials before nephrectomy, and we hope the Patient Champion Programme will equip patients with the knowledge and information to be able to talk to clinicians about clinical trials.

The day was very interactive with plenty of questions and input from the floor. Everyone left the workshop wanting to take action to move kidney cancer research forward and to help and support patients in the future. Overall, a very successful and positive meeting. A big THANK YOU to everyone who took part!

unspecified-7Our second Patient Champion Programme Clinical Trials Workshop was held at The Christie Hospital on Thursday 2nd February 2017 with a group pf very dedicated and enthusiastic patients and carers. KCSN and Dr Fiona Thistlethwaite, consultant medical oncologist at The Christie, jointly hosted the workshop.

Download the agenda for this meeting by clicking on the link below:

Patient champion workshop agenda Manchester FINAL

Rose opened the meeting with some background to the Patient Champion Programme. This meeting is an exploratory meeting to gauge interest in the Patient Champion Programme and to identify patient champions for the North West, North East and Midlands regions who are prepared to get involved and build awareness of kidney cancer clinical trials in their regions. Rose thanked The Big Lottery, Pfizer, and Novartis for their support with the Patient Champion Programme.

unspecified-6The new KCSN website, specifically the Clinical Trials Hub, the clinical trials database and the Information Hub, was well received by theimage005 copy patients and carers. The clinical trials database will be updated monthly with the support of the KCSN Medical Advisory Board and the pharmaceutical industry. Sharon Kell is responsible for keeping the Clinical Trials Hub and database up-to-date, so if you know of any clinical trials that are not listed on the database, please let Sharon know. Julia Black is an experienced advocate for access to treatments, and can help patients who are trying to access treatments through the complicated processes for Individual Funding Requests and the Cancer Drugs Fund.

Dr Fiona Thistlethwaite gave an overview of clinical research, including why we need cancer research, what is a clinical trial, what does taking part in a trial involve from a doctor’s perspective, and what are the current questions in kidney cancer? Her presentation can be downloaded here:

Patient Champion Workshop – Fiona Thistlethwaite

During Dr Thistlethwaite’s presentation, there was some discussion about patient travel reimbursement for clinical trials. Most trials, academic and industry, provide travel grants for patients, although there is a limited pot of money for academic/investigator-led trails.

unspecified-2There was also a discussion about dropouts during clinical trials. If a patient withdraws from a trial, they will go on to receive standard treatment for their kidney cancer. However, taking an investigational drug may affect their eligibility for subsequent clinical trials.

Dr Thistlethwaite concluded her presentation by discussing the current questions in metastatic kidney cancer:

 

unspecified-1Jeffrey Wynn Davies is Managing Director of Bury Music Service Ltd, an Arts Council funded company that provides music education services to children and schools within Bury Metropolitan Borough. He enjoys a national reputation as a choral conductor, and has conducted, given workshops and judged at music festivals around the world. He served on the BBC Central Music Advisory Committee throughout the 1980s and has recently raised funds for kidney cancer research in conjunction with the former (and still occasional) BBC newsreader Nicholas Owen, a fellow renal cancer survivor.

Jeffrey was diagnosed with advanced renal cancer in August 2012. Following his nephrectomy, he took part in a clinical trial of atezolizumab (a PD-L1 inhibitor) compared to sunitinib and was randomised to receive sunitinib. One of the main benefits of taking part in a clinical trial is the constant monitoring of his condition by the research team using CT scans and physical examinations.

 

unspecified-3Susanna Smith has been a nurse for 17 years, the last 7 in oncology at the Christie. She has been involved in clinic trials for the last 3 years and has worked in the area of lymphoma, oesophageal and kidney cancer. Her primary focus is kidney cancer and new clinical trials. She has also set up a Greater Manchester kidney cancer support group, which started in January and will run bimonthly.

Susanna talked about the role of the research nurse, kidney cancer research, and the current trials that are recruiting at The Christie. She finished her presentation by talking about the kidney cancer support group that she is running for patients and carers in the Greater Manchester area. You can download her presentation here:

Patient Champion Workshop – Susanna Smith

 

unspecified-4Karen Inns, Patient and Public Involvement Lead at the National Institute for Health Research (NIHR), with the help of Janet Eastwood, Head of Communications for the Greater Manchester NIHR Clinical Research Network (CRN), talked about the importance of patient and public involvement (PPI) in research and the NIHR clinical research networks. The NIHR is the main funding body for NHS clinical research. You can download their presentation here:

Patient Champion Workshop – Karen Inns unspecified

Karen talked about good clinical practice (GCP), publications and conferences as being a means of sharing research ideas and results globally to add to the evidence base. Patients need to be involved with this.

She also talked about the ways patients can become involved in clinical research and initiatives, such as INVOLVE, the Patient Research Ambassador Initiative (PRAI), the NIHR patients and public website, the NIHR Learn Zone, Massive Open Online Course (MOOC) improving healthcare through clinical research, and the OK to Ask (about clinical research) campaign.

 

unspecified-5Dr Fiona Thistlethwaite and Rose Woodward concluded the workshop with an introduction to the work of the National Cancer Research Institute (NCRI) Clinical Studies Groups. The aim of the NCRI is to improve cancer research in the UK. Clinical Studies Groups bring together oncologist, surgeons, statisticians, and consumers (patients) concentrating on trials for the treatment of one particular cancer type. They develop research studies that compliment industry research. The consumer voice is valued in the Clinical Studies Groups, and patients are able to influence clinical trials/research with their ideas.

Within each of the 15 CRNs there is a specialty lead for urology. Patient champions need to identify the urology lead for their local CRN and liaise with them over clinical trial/research opportunities. We need to make a noise to raise the profile of kidney cancer clinical trials within the CRNs. The names of the specialty leads are published on the NIHR website under each CRN.

The Bladder and Renal Cancer Clinical Study Group are about to embark on a new trial called RAMPART, follow-up to SORCE using immunotherapy adjuvant therapy. The study is planned to open in the third/forth quarter 2017. It is an academic study requiring 2,000 patients with intermediate/high risk of recurrence who are given immunotherapy adjuvant therapy within 12 weeks after nephrectomy. Patients need to be identified before they have surgery to ensure the 12-week window is not missed. Patients need to be empowered to make surgeons/oncologists aware of adjuvant trials before nephrectomy, and we hope the Patient Champion Programme will equip patients with the knowledge and information to be able to talk to clinicians about clinical trials.

The day was very interactive with plenty of questions and input from the floor. Everyone left the workshop wanting to take action to move kidney cancer research forward and to help and support patients in the future. Overall, a very successful and positive meeting. A big THANK YOU to everyone involved!

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