IWMF WhiMSICAL Registry flyer DOWNLOAD <——- Select “DOWNLOAD” for copy of IWMF WhiMSICAL Registry flyer
Welcome to the WhiMSICAL Registry
WM patients globally are invited to contribute their details to the WhiMSICAL (Waldenström’s Macroglobulinemia Study In CART-WheeL) Registry, and print out your own summary for personal use. Data entered by / for WM patients will contribute to research on our disease. The Registry is designed to address some of the barriers facing effective research into our rare cancer. The aim is to gain a better, understanding of WM symptoms and correlation to pathology results, family history and genetics. The research also covers triggers to commence therapy, different treatments, their efficacy and tolerance, as well as disparities in treatment access within countries and internationally. Data from WM patients provided in WhiMSICAL has been presented at international conferences. This is an opportunity for WM patients to drive international research into their disease. In April 2020 WhiMSICAL has been enhanced to include specific questions on the impact on WM patients of COVID-19 irrespective of actual COVID-19 infection or not.
Following is information on:Why join WhiMSICAL Regisry
- Features of WhiMSICAL
- History of WhiMSICAL
- How WhiMSICAL works
- How to take part in WhiMSICAL
- Consent for use of your de-identified data by Research Investigators
- Tips on getting started with WhiMSICAL.
- Enquiries and support
- WhiMSICAL Regisgtry flyer
1. Why Join WhiMSICAL?
2. Features of WhiMSICAL include:
- A personal summary of disease experience, including graphing of your Haemoglobin and IgM levels to use as a personal profile and for use in consultations with your physicians, with capacity for ongoing revision with future entries
- Authorised clinician researchers gain access to de-identified data for a better understanding of Waldenström’s macroglobulinemia and for improved treatments for patients, both globally or for their own country.
- Access to data is solely to advance the research and information priorities of the investigators and patients and carers who enter the data. While the Registry is approved by the Ethics Committees of Royal Melbourne and Concord Repatriation General Hospitals in Australia. WhiMSICAL is a global research project, supported by the IWMF.
- A robust proven processing platform which securely holds medical data on over a million patients
- A powerful analytical tool to support ease of use by Investigators
- A potential for “Big-Data”
3. History of WhiMSICAL
Initial recruitment efforts illustrated below were driven through messaging by WMozzies, to establish feasibility of the platform, resulting in 69 patients (16%) joining the study in 12 months (29% of study duration). Subsequent social media messaging by the IWMF to members globally led to a significant surge in the number of participants (A). Messaging regarding the addition of the Quality of Life questions EORTC QLQ-C30 to the questionnaire led a second surge in recruitment (B).
WhiMSICAL Registry has 418 members at April 2020 (40% of big data goal of 1,000 members). As illustrated below the WhiMSICAL Registry members are from 18 different countries. 46% of members are from the US.
The WhiMSICAL Registry has been presented at the following major International conferences of leading WM clinicians and researchers at:
- International Conference on Malignant Lymphoma, Lugarno June 2019
- European Haematology Association Conference, Amsterdam June 2019
- 10th International Workshop on Waldenstrom’s Macroglobulinemia (IWWM-10) in New York on 11-13 October 2018
- American Society of Haematology (ASH) meeting in Atlanta on December 9th 2017
- 9th International Doctor-Patient Forum on WM in Amsterdam on, 9 October 2016
WhiMSICAL represents an innovative and robust platform to generate patient-derived data and reported outcomes, with demonstrated good concordance with lymphoma registry data. Further quality of life questions (EORTC QLQ-C30) have recently been added. As an expanding and increasingly reliable body of data, WhiMSICAL has the potential to map real-world PROs, break down clinician-patient barriers and provide a scientific and ethically-approved portal for patients’ voices globally.
The poster presented in June 2019 is shown below. Highlights from the WhiMSICAL Registry poster include:
- · High levels of stress symptoms 11.8% of stress levels equivalent of post-traumatic stress disorder
- · Marked treatment diversity in real-world 41 unique first line therapeutic combinations· Significant variation in treatment access by country Fewer government funded and clinical trial therapies in the US compared with the rest of the world (ROW), however the median time to first treatment was sooner in the USA than ROW (48 v 114 days, respectively).· QUALITY OF LIFE Analysis of early data or raw scores comparing BTK and non-BTK inhibitors
Further recruitment (Project 1000) Growth gives potential to map real world QoL to treatments and provide a scientific and ethically approved portal for patients’ voices globally
4. How WhiMSICAL works
WhiMSICAL uses a privacy-protected, internet-based questionnaire. WM patients complete this questionnaire on the CART-WHEEL.org website. They have control over personal details by providing consent to different uses of entered data. A Comparison of WhiMSICAL patient-derived data with Lymphoma and Related Diseases Registry available data has been completed for 21 patients. There were high completion rates and good concordance with diagnosis and treatment data but higher variability with IgM data.
The WhiMSICAL CART-WHEEL questionnaire covers:
- Patient demographics
- Disease specifics: staging, chronology of symptoms, IgM levels, full blood count information, etc.
- Treatments, how accessed, and treatment side-effects
- Personal and family medical history
- Quality of Life (EORTC QLQ-C30)
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 and the overall Quality of Life scales 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.
5. How to take part in WhiMSICAL
Register (Create a 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 log in 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
- 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. The WhiMSICAL Registry special section is automatically generated when you enter Waldenström’s or lymphoplasmacytic lymphoma into your diagnosis in Question 3. Make sure you select your diagnosis from the drop-down menu (See – Make sure you select your diagnosis from the drop-down menu (See 5. What are the tips for completion Question 3 on Diagnosis? in the “WhiMSICAL Frequently Asked Questions” webpage)
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 a few hours depending upon for 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 enter 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 pathology test results is most important, especially those around the time of diagnosis, before and after treatment and the most recent.
Complete the Consent Form (Without a completed 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 research project.
Submit the Consent Form to CART-WHEEL online.
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.
6. Consent for use of your de-identified data by Research Investigators
Details recorded cannot be used for research until formal consent is given. The privacy and confidentiality of patient details in WhiMSICAL are safeguarded globally by strict ethical, scientific and legal standards. The CART-WHEEL project has been granted ethical approval by the Health Human Research Ethics Committee (HREC) based at The Royal Melbourne Hospital, Australia. This means that only with your consent, can your information be used to further cancer research.
In the Consent process, participants are given very detailed information about the project. All the procedures involved in this project are explained 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. (For further detail See – 6. What are the tips for completion of consent form? in “WhiMSICAL Frequently Asked Questions” webpage)
7. Tips on getting started with WhiMSICAL
- Note throughout that CART-WHEEL uses the word “tumor” to refer to cancer of any part of the body, including blood and lymph glands
- Start with an easy small step and come back later to do more.
- In the first instance enter details for Questions 1-3 with demographics (age, location), date of diagnosis and then complete Consent.
- See separate tips for Question 3 Diagnosis and for Consent
- Give priority in data entry after entering Questions 1-3 data and Consent to:
- Question 9 Your Treatments
- Question 19.1 Your WM symptoms
- Question 19.5 Your Pathology results particularly your IgM and hemoglobin details at diagnosis, at start and completion of each treatment course and your most current data
- Note in Pathology test results in Question 19 Abnormal or Paraprotein Band (M-spike) in WhiMSICAL is called Serum Paraprotein Level in Question 19.
- Then as it suits you slowly work through the rest of Questions later
Joining WhiMSICAL and spending a few hours entering your details will help current and future WM patients around the world. WhiMSICAL database will help us get closer to a cure and benefit WMers and WM researchers across the globe. Consider it your personal scientific contribution to conquering WM.
8. Enquiries and support
General information – IWMF and WMozzies: firstname.lastname@example.org
Support from WM patients using WhiMSICAL: email@example.com
Technical support and user problems: WhiMSICAL CART-WHEEL: firstname.lastname@example.org
Frequently Asked Questions http://www.wmozzies.com.au/index.php/whimsical/whimsical-frequently-asked-questions/