There is beauty in numbers.
Welcome to the PROgress Tracker Breast Cancer Registry.
PROgress Tracker Breast Cancer Registry is a knowledge-based research study collecting Patient Reported Outcomes (PRO) data through the use of questionnaires from diverse experiences of breast cancer participants from diagnosis, treatment and surveillance over the course of time. People diagnosed with breast cancer at any stage, during any period of their journey will complete questionnaires four times a year to share their individual experience and outcomes of breast cancer across Canada. The data will be collected into a database for researchers and clinicians to analyze large population responses and learn more about breast cancer issues and improvements from the patient perspective.
As this is a research study, it is governed by a Research Ethics Board and requires participants to sign consent to participate in the study, provide demographic information about themselves and their breast cancer, and complete questionnaires every three months. All personal information is kept strictly confidential. Participants responses to the questionnaires are not shared with their doctor or medical care team.
People that are eligible to participate in PROgress Tracker include:
– Female or male, 18 years old, at the time of informed consent
– Having a diagnosis of stage 0 (DCIS) to IV breast cancer according to the TNM system classification of breast cancer
– Breast cancer must be confirmed by histological classification following breast biopsy and/or surgical resection of primary or metastatic lesion.
– Being able to give electronic, informed consent (or have a legal representative who can give electronic informed consent when applicable).
– Be able to complete questionnaires in English or French
– Be able to accept and respond to email communications
The minimal length of duration of the registry will be 10 years with the possibility of extension. The study will collect PROs data from participants over 10 year period every four months. Participants can stop being in the study at any time.
We invite you to learn more by reading the additional information provided here or contacting a Breast Cancer Canada volunteer to answer your questions at tracker@breastcancerprogress.ca
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FAQ
Frequently Asked Questions
The breast cancer experience can affect your life in many ways. We are doing this research registry to learn about what people’s lives look like after breast cancer diagnosis at any stage and any treatment that is required as a result to understand the impact to your life. The study will also help us give better care to future patients.
We are conducting this registry to learn about what people’s lives look like after a breast cancer diagnosis and any form of breast cancer therapy. Researchers can look at the information that is provided by participants to learn more about health and treatment. The analysis of these data will help with new discovery of issues that breast cancer survivors experience. This could lead to more directed research, updates in health care polices or treatment advances.
Breast Cancer Canada is conducting the study and has enlisted expert groups to run and maintain the research database, all under research ethics and privacy of information standards.
BCC volunteers are trained on the study and able to answer questions from people with breast cancer that are interested in participating in the study. Volunteers can also help with questions for those who have entered the study.
If you decide to take part in the study, information will be first collected from you to the best of your knowledge about you and your breast cancer diagnosis. Then, 4 times a year or every 3 months, you will answer a series of surveys. The surveys are emailed to you directly and will take 15-30 minutes to complete, in total, every 3 months.
We are asking participants to be involved in the study for as long as they can up to 10 years in order to capture short-term, mid-term and long-term changes after the experience of any stage of breast cancer diagnosis and any treatment.
- Have been diagnosed with breast cancer at any stage 0, I, II, III or IV
- Reside in Canada
- Are able to answer surveys (also known as questionnaires) about your health and well-being. The questions will be available in English and French, and you can use any translation or assistive device to help read the questions in a format you prefer.
- You are able to answer the surveys wherever you have access to the internet and can receive and send e-mail.
- Taking part in this study may or may not help you. The information from this study may help future patients have better care during and after their experience with breast cancer.
- There are few risks with taking the surveys.
- Some of the questions or topics may upset you. Your doctor will not contact you about your responses, so if you have any concerns about your feelings or thoughts, tell your doctor right away.
- If you do not feel comfortable responding to a question, you may choose not to answer it.
It will not cost you anything to join this registry. You will not be paid for taking part in this registry. Participation in the study is on a voluntary basis.
Yes you can withdraw from the study at any time. If you choose to leave this study, it will not affect your regular medical care in any way. If you leave the study after giving us survey answers, we will keep the data you have provided and not request further surveys from you.
We have in place all the safety and protection of personal information standards in place, however there is a small risk that someone could find out which answers are yours. We will do everything we can to keep your answers confidential. Your answers to the surveys will not be shared with healthcare providers or with your medical teams. However, if there is something that you find a survey question has highlighted as a medical question, you are encouraged to direct your question to your healthcare provider.
You have the right to ask questions about the study at any time. If you have questions about the study, please contact:
- Breast Cancer Canada
- Call: 1-800-567-8767
- Email: tracker@breastcancerprogress.ca
- It is expected that the information collected during the study will be used in analyses and will be published and/or presented to the scientific community at meetings and in journals, but your identity will remain confidential.
- Your survey results may also be used in sub-studies you specifically consent to, or for process improvement and evaluation within PROgress Tracker database.
You may be contacted for your interest to participate in additional surveys as a sub or add-on study that would be incorporated within this PROgress Tracker database Registry. These sub-studies look to collect a deeper level of information on a specific topic. You can choose to participate or not to participate in these additional survey questionnaires, which does not exclude you from ongoing participation in the PROgress Tracker Registry.
When research results are published, we will make every attempt to share the findings with you to be able to see how the study is progressing.
It is a place, like a library, where researchers collect information, like survey answers. Other researchers can look at the information to learn more about health and treatment.
Protecting your Privacy and Confidentiality:
Any data collected about participants during this Registry will not identify them by name, only by an alpha-numeric code. The participant’s first and last name and her/his contact study information will be stored in the database for 10 years following the end of the active Registry data collection period. Presentations or published scientific reports will not release participant’s identities.
Patient medical records will never be consulted by Breast Cancer Canada staff member. The information collected for the purposes of the Registry is based on participant’s self-declaration only. None of the information collected will be provided to members of medical staff or to the medical center which follow the study participant.
Prior to initiating any research involving PROgress Tracker Breast Cancer Registry data, researchers wishing to use data will be required to obtain a Research Ethics Board approval. Data transmitted to a researcher who was granted access for research purposes will be anonymized (de-identified) to protect registry participants’ privacy. A policy oversees the management of this database. This policy is reviewed regularly to meet ongoing legal and ethical requirements. It is available upon request.
There is no risk involved in participating in the PROgress Tracker Registry aside from the possibility of a breach of confidentiality. However, if a breach of confidentiality does happen, the participant will be informed as soon as possible. The sponsor, Breast Cancer Canada, will be informed and the event will be submitted to the governing Research Ethics Board for the study.
Within the context of the registry, research data is defined broadly as any data collected from the participant. Data contained within the registry database have several purposes: to serve as a record of the investigation, to form the basis on which conclusions are made, and to serve as a platform from which new research questions may be generated. In keeping with its commitment to promote integrity in the research process, the data management practices set out herein are designed to ensure open and timely access to research data, while respecting compliance with legal or regulatory requirements, confidentiality and personal privacy of research participants.
Breast Cancer Canada is the sponsor and owner of this registry. As such, it has the responsibility of assuring its management and of obtaining sufficient funding for the continuation of the project.
The Registry Coordination Center for Breast Cancer Canada is the custodian of the database which is housed in a cloud-based storage program developed within the secure Google Health platform. The database is monitored under the guidance of Breast Cancer Canada by our hired research coordination group, SciMega and managed for functionality by our hired Information Technology group, CloudifyAI. It receives funding from Breast Cancer Canada for the development, coordination, and implementation of the registry. The Registry Coordination Center has complete access to all data elements contained in the registry database.
A database policy oversees the PROgress Tracker Registry. Data storage is performed on a protected, backed up and secured cloud-based storage medium managed by the Registry Coordination Center via an information technology service provider that is in-licensed and maintains all personal data security standards in Canada. Only personnel designated by the sponsor, Breast Cancer Canada, has authorized password protected individual user access thereto.
PROgress Tracker has been made possible through the generosity and commitment of our Breast Cancer Canada donors.
Thank you to the Lotte & John Hecht Memorial Foundation who is generously contributing $200,000 to PROgress Tracker over the next 3 years.
We would also like to thank our partners in research:
