Martino, R. http://orcid.org/0000-0002-3298-7714
Fitch, M. I.
Fuller, C. D.
Hope, A.
Krisciunas, G.
Langmore, S. E.
Lazarus, C.
Macdonald, C. L.
McCulloch, T.
Mills, G.
Palma, D. A.
Pytynia, K.
Ringash, J.
Sultanem, K.
Theurer, J.
Thorpe, K. E.
Hutcheson, K.
Funding for this research was provided by:
Patient-Centered Outcomes Research Institute (PCS-1609-36195)
Article History
Received: 21 June 2021
Accepted: 1 October 2021
First Online: 13 October 2021
Declarations
:
: All versions of the study protocol and informed consent forms will be reviewed and approved by the Research Ethics Board (REB/Institutional Review Board (IRB) of each site before the trial is implemented. The Princess Margaret Cancer Centre (PM), part of the University Health Network (UHN) in Toronto, ON is the prime site and was reviewed by Clinical Trials Ontario, as the review of record (CTO Project ID: 1363). In addition, the remaining ten participating sites also underwent local ethics review. Across all sites, PRO-ACTIVE informed consent forms are harmonized for relevant trial particulars while adhering to local REB/IRB standards. As part of the informed consent process, the PRO-ACTIVE study team will only approach participants once they have shown interest in the trial to a member from their direct circle of care. The study team will explain the research study to the participant and answer any questions that may arise. A verbal explanation will be provided in terms suited to the participant’s comprehension of the purposes, procedures, and potential risks of the study and of their rights as research participants. Participants will have the opportunity to carefully review the written consent form, ask questions and discuss the study with their family or surrogates prior to agreeing to participate. The participant will sign the informed consent document prior to any procedures being done specifically for the study. Participants will be informed that participation is voluntary and that they may withdraw from the study at any time, without prejudice. A copy of the informed consent document will be given to the participants for their records. The informed consent process will be conducted and documented in the source document (including the date), and the form signed, before the participant undergoes any study-specific procedures. The rights and welfare of the participants will be protected by emphasizing to them that the quality of their medical care will not be adversely affected if they decline to participate in this study.
: not applicable.
: The authors declare that they have no competing interests.