Participation in the WhiMSICAL Study by the IWMF and its International affiliates is now being promoted. The WhiMSICAL Study was launched in Australia in June 2016 and is now successfully established. It is a robust ethically-approved WM data-collection platform generating patient-derived data. WhiMSICAL study already has 67 participants (70% Australia & NZ, 16% US, 4% UK and Netherlands, 3% Canada, 2% Belgium). WhiMSICAL was presented at IWWM9 to a group of international WM clinicians generating strong interest. Expanded recruitment is now planned through broader support of WM clinicians internationally and from the IWMF and its international affiliates. With ongoing prospective patient data updates and international expansion a significant increase in WhiMSICAL data is anticipated in coming years. The breadth of information gathered will expand WM knowledge of the range treatment presentations and treatments. This will complement the depth of data derived from clinical trials and site-based registries. Demonstration of any treatment disparities, coupled with information regarding treatment efficacy may facilitate novel therapies.
Features of WhiMSICAL include:
- A database designed to address some of the barriers facing effective research into rare cancers.
o Gain a better, real-world understanding of WM symptoms and correlation to pathology results, family history and genetics
o Triggers to commence therapy
o Different treatments, their efficacy, and tolerance
o Disparities within countries and internationally.
- A personal summary of disease experience to use as a personal profile and for use in consultations with their physicians with capacity for ongoing revision with future entries
- Authorised researchers gain access to de-identified data for a better understanding of Waldenström’s Macroglobulinemia and for improved treatments for patients
- Access to data is solely to advance the research and information priorities of the investigators and patients and carers who enter the data. The study is subject to ethical approval of the Ethics Committees of Royal Melbourne and Concord Repatriation Hospitals
- A sound proven processing platform using BioGrid which securely holds medical data on over a million patients
- A powerful SASS analytical tool to support ease of use by Investigators
- A potential for “Big-Data” to analyse demographic differences both now and in the future
Details on WhiMSICAL follow covering:
- How WhiMSICAL works
- Example of WhiMSICAL Content
- How to take part in WhiMSICAL
- Consent for use of your de-identified data by Research Investigators
- Enquiries and support
How WhiMSICAL works
- CART-WHEEL uses a privacy-protected, internet-based questionnaire. WM patients complete this questionnaire on the CART-WHEEL.org website and have control over personal details by providing consent to different uses of entered data. A correlation study has demonstrated a 75% concordance with clinical-entered data.
- The questions include:
o Patient demographics
o Disease specifics: staging, chronology of symptoms, IgM levels, full blood count information, etc.
o Treatments, how they were accessed, and treatment side-effects
o Personal and family medical history
- For individual WM patients, WhiMSICAL provides a summary (profile) of questions and responses. This is handy as an individual’s personal record and for review with their physician. Test results are also presented graphically. The graphs show trend lines for each of the Pathology results entered and include details of treatments received. Graphs may be tailored for any combination of test results and period desired
Example of WhiMSICAL Content
How to take part in WhiMSICAL study
Register (Create CART-WHEEL account https://www.cart-wheel.org/ )
The setup of a CART-WHEEL account includes creating a username and a password to use to login to the questionnaire. This gives an option to save information at any time and to log in later to update the information.
Complete the questionnaire
It will be useful before you start the questionnaire. to have:
- a copy of your pathology report with the specific name of your rare cancer/ tumor
- information about the hospitals or medical centres where you have been treated
- the names of the treatments that you have received
If you do not have all the required information immediately available, you can update your answers to those questions at a later date.
Your information will be entered via a secure connection and cannot be seen by anyone else. At the end of the questionnaire you will be able to print out a summary of questions and your responses for your record.
Entering the data requires WM patients to spend anywhere from half an hour to multiple hours depending upon how long they have had WM and how many treatments they have had. It is suggested you start by entering only readily available details. Login again later to details such as test results and BMB details. The time spent in recording your details is valuable for WM research and well worth the effort. Entry of test results is most important for those around the time of diagnosis and before and after treatment.
Complete the Consent Form (Without this consent form, the information provided cannot be used)
Completing your Consent Form confirms your permission for use of the entered information for the purposes of research. This is an important requirement of the Human Research Ethics Committee that protects your rights and confirms that you understand the purpose of this project. The
Submit the Consent Form to CART-WHEEL online, or by email or mail
Once you are logged into the Questionnaire, select ‘My Consent details’ in the top right of your screen. Select the ‘Add Consent’ button. This will provide on screen the relevant information to enable you to consent to your participation in CART-WHEEL.
Consent for use of your de-identified data by Research Investigators
Details recorded cannot be used by approved researchers until formal consent is given. Details about Consent cover:
- Importance of the Consent process
- Participant information
- Consent form completion
Importance of the Consent process
The privacy and confidentiality of patient details in WhiMSICAL CART-WHEEL are safeguarded by strict ethical, scientific and legal standards. This project has been granted ethical approval by Melbourne Health Human Research Ethics Committee based at The Royal Melbourne Hospital, Australia. This means that only with your consent, can your information be used to further cancer research.
BioGrid Australia provides the secure web-based infrastructure linking the privacy-protected and ethically approved data necessary to assist researchers and clinicians improve their research and clinical outcomes. BioGrid Australia is structured so that patient identifying and clinical information are kept separate. This means researchers can never know the identity of the patients whose information is stored in the databases. Researchers can conduct research while patient privacy is fully protected.
In the Consent process, Participants are given detailed information about the project. This explains all the procedures involved in this project before you decide whether or not to take part in it. Once you understand what the project is about and if you agree to take part in it, you will be asked to provide your consent by completing the Consent Form. By completing and submitting the Consent Form, you indicate that you understand the information and that you give your consent to participate in the project
Consent form completion
The consent form is necessarily comprehensive to ensure the privacy and confidentiality of patient details. It covers:
- Introduction and background in pages 1 to 4
- BioGrid Australia on page 5
- Questionnaire completion on page 6
- Levels of consent on page 7
- Information contained in WhiMSICAL CART-WHEEL data base in pages 8 to 11
- How privacy is protected in pages 12 to 13
- Benefits, risks, further information, problems, voluntary participation in pages 14 and 15
- Ethical guidelines on page 16
- Consent permission on page 17
- Consent summary confirmation on pages 19 and 20
Suggested Tips for WM patients to streamline completion of form follow:
- Choose Online option for Consent form as it is easier and quicker
- Consent to all 5 options on page 7 ensures the maximum benefit for research purposes from data provided
- The sections of the consent form on pages 8 to 10 regarding tissue sample specimens and blood samples stored in tissue banks are not relevant to the WhiMSICAL CART-WHEEL study
Enquiries and support
Contact details for information or any technical and user problems:
Phone: +61 3 9342 2690 Fax: +61 3 9342 8548 Email: email@example.com
Level 8, CMR Building, Royal Melbourne Hospital, 300 Grattan Street, Parkville, Victoria, 3052, Australia
Postal Address: PO Box 2138, Royal Melbourne Hospital, VIC, 3050 Australia
Personal assistance in using WhiMSICAL is available from have WMozzies who are experienced in providing User support. This has proved useful particularly in helping enter pathology test results. Contact for further details on this personal support:
Andrew Warden Phone: +61 4 0830 3718 Email: firstname.lastname@example.org