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 cancer1
– 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
NEED HELP GETTING STARTED?
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 a expert program, named POET at the University of Calgary, to develop, run and maintain the research database.
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.
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, located at POET Program, University of Calgary, is the custodian of this registry and is under the guidance of the Sponsor of this project. 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 computer-based storage medium managed by the Registry Coordination Center via an information technology service provider that is in-licensed and maintained as an onsite storage system at the University of Calgary. Only personnel designated by the sponsor has authorized password protected individual user access thereto.
The Registry Coordination Center, The POET Program, being part of the University of Calgary, is also subject to ethics approval of this protocol and conduct of the study.
The PROgress Tracker Breast Cancer Registry custodianship is the physical possession of and direct responsibility for protecting research data, including accurate recording and proper retention, maintenance, access, sharing and disposition of the data. As custodian of the PROgress Tracker Registry, being the Registry Coordination Center will assure maintenance of all records in accordance with applicable privacy and confidentiality legislation so as to prevent unauthorized access, destruction, alteration or removal, accidental or intended damage or destruction. The Registry Coordination Center will have complete access to all data elements contained in the PROgress Tracker Registry database.
The results of research derived from the PROgress Tracker Breast Cancer Registry may be published in journals or presented at scientific meetings. If this is foreseen, the researcher agrees to submit any manuscript, paper, poster presentation or oral presentation, or abstracts to BCC before submission for publication. The researcher must state in its publications or presentations the data used came from the PROgress Tracker Breast Cancer Registry of BCC.
Doris Howell PhD, Breast Cancer Canada Scientific Advisory Committee PROS Chair
Professor (status) at the University of Toronto’s Lawrence Bloomberg Faculty of Nursing
Emerita/Emeritus Scientist, Princess Margaret Cancer Centre
Dr. Doris Howell was trained as a health services researcher and is now also focused on clinical intervention research. The goal of Dr. Howell’s research program is to improve the patient’s experience of cancer care, through health intervention research focused on better care delivery systems and clinical interventions for complex symptoms (fatigue, breathlessness, pain). Her main focus of intervention research is on understanding how psychological factors such as beliefs influence symptom response and adaptation to illness and how these might be modified through behavioral self-management interventions. Additionally, the efficacy and effectiveness of nurse-led behavioral self-management interventions in reducing symptom distress is a clinical research focus.
Dr. Howell also has an active health service research program focused on knowledge translation of best practices in care delivery, specifically the application of chronic disease self-management for survivorship. The testing of routine collection of Patient-Reported Outcomes (PRO) and their use in clinical practice to improve care quality and patient experience of cancer will enable this research.
Dr. Howell leads standards and guideline development and is a member of the national distress management implementation team under the Canadian Partnership Against Cancer. Dr. Howell is the Co-Director of the Ontario Patient Reported Outcomes Symptom and Toxicities (On-PROST) and is cross-appointed as Professor (status) at the University of Toronto’s Lawrence Bloomberg Faculty of Nursing.
Dr. Omar Khan Breast Cancer Canada Scientific Advisory Committee
Clinical Assistant Professor, Department of Oncology, Division of Medical Oncology, University of Calgary
Dr Omar Khan’s research focuses on the application of artificial intelligence to cancer care, particularly for the breast cancer and sarcoma tumour groups. He is also involved in clinical trials at the Tom Baker Cancer Centre, and is a co-investigator on a grant from the Alberta Cancer Foundation focused on defining the tumour and immune cell architecture of undifferentiated pleomorphic sarcoma.
Dr Omar Khan is a clinical assistant professor at the Cumming School of Medicine and medical oncologist at the Tom Baker Cancer Centre. He completed his Medical Doctorate at the University of Calgary in 2013, followed by Internal Medicine and Medical Oncology residency training at the University of Calgary from 2013 – 2018. He completed a fellowship in Breast Cancer and Health Administration from 2018 – 2019. He also completed an executive MBA degree at the Ivey Business School at the University of Western Ontario, graduating in 2020. He received the Novartis Oncology Young Canadian Investigator Award in 2017 and a Young Oncologist Merit Award from the European Society of Medical Oncology in 2018. His current clinical practice includes the breast cancer and sarcoma tumour groups. His research interests are in the application of artificial intelligence to clinical cancer care.
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 $210,000.00 to PROgress Tracker over the next 3 years.
We would also like to thank our partners in research:
