Please take a few minutes to read more about the study below.

TITLE
Barriers to Patient Enrolment in Oncology Clinical
Trials at a Canadian Regional Cancer Centre: A Mixed Methods Study

SPONSOR INVESTIGATOR
Angelina Singson, HBSc. CCRP
Faculty of Health Sciences, Ontario Tech University
Research, Lakeridge Health

INTRODUCTION
You are being invited to participate in a research study. This research is on barriers to enrolment in cancer trials at a Canadian Regional Cancer Centre. You are being invited to take part because you are an adult patient, diagnosed with cancer, and you are currently being treated for at the Durham Regional Cancer Centre. You also have the ability to speak, write, and read in English.

This consent form is intended to provide you with the necessary information to make an informed decision on whether or not you would like to join the study. Your decision is completely voluntary. You also do not have to decide today whether or not you will participate in the research, and you can talk to anyone you feel comfortable with about the research before you make a decision.

BACKGROUND
Randomized controlled trials (also called “clinical trials) are important to the development of new cancer treatments. They are types of research that assess whether or not new treatments safe for people and whether or not they work. Before new treatments are approved for use in Canada, they must show success through different phases of clinical trials. Phase I clinical trials are done to determine safe doses that cause fewest side effects, Phase II trials to see if the treatment does what it’s intended to do, Phase III trials to see if the treatment is better than an approved standard treatment, and Phase IV to see the long term effects of the treatment. Through clinical trials, we can expect better treatments and higher rates of patients being cured of cancer.

Canadians generally have a positive view on clinical trials and their importance in society. However, only around 1% to 5% of adult cancer patients participate or enrol in clinical trials. Patient participation or enrolment in clinical trials is defined as a patient being informed about study information and the patient choosing to participate in the clinical trial. Low enrolment rates might mean that the effectiveness and safety of treatments that might not apply to the general cancer populations. In other cases, low recruitment rates are also one of the reasons why many clinical trials might not continue and the development of new treatments are slowed down.

PURPOSE
Most of what we know about barriers adult cancer patients might face that prevent them from participating in cancer research is based on information from large research centres, or outside of Canada. We want to learn more about what these barriers might be at a Canadian Regional Cancer Centre such as the Durham Regional Cancer Centre (DRCC). Through this study, we hope to inform strategies to help improve patient enrolment and research at the DRCC.

TYPE OF RESEARCH INTERVENTION
 This study will involve your participation in a questionnaire which is 49-question long and may take around 15 minutes to 20 minutes to complete. Through the questionnaire, we would like to learn more of what factors might lead you to your decision to participate in a trial.
If you have previously declined to take part in a clinical trial, we will also be inviting you to a second part of the study. This part will involve a short 30 minute telephone interview. Through this interview, we would like to learn more about why you might have chosen not to participate, your experiences, and your feelings about cancer clinical trials.

PARTICIPANT SELECTION
You are being invited to take part because you are an adult patient, diagnosed with cancer, and you are currently being treated for at the Durham Regional Cancer Centre. You also have the ability to speak, write, and read in English. Our study will involve around 80 participants and the interviews will involve around 5 to 6 participants.

VOLUNTARY PARTICIPATION
Your participation in this research is completely voluntary. It is your choice whether to participate or not. If you choose not to participate the care that you receive at the DRCC will continue and nothing will change.

PROCEDURES
For this study, we would ask you to fill out a survey. If you do not wish to answer any of the questions included in the survey, you are free to skip them and move on to the next question.

RIGHT TO WITHDRAW
You can also choose to withdraw at any time during the survey. If you are uncomfortable with asking any of the questions in the survey, you can choose to skip to the next question.

RISKS
There no currently known risks involved with your participation in this study. However, if you feel uncomfortable at all during the survey, please let me know and we can skip to the next question or you are free to withdraw at any time.

BENEFITS
This study will have no direct benefit to you; however, the information learned from this study will be used to help strategies to improve cancer research at the DRCC.

CONFIDENTIALITY
Every measure will be taken to ensure that your confidentiality will be maintained. You will not be asked for information that would identify you. Study documents will be maintained in a secure and locked place on-site at the DRCC during the study and up to 7 years after study closure or in accordance with institutional requirements.

AGREEMENT TO PARTICIPATE
Your decision to complete and return this survey will be interpreted as an indication that you have read the foregoing information and of your voluntary agreement to participate. In no way does this waive your legal rights nor release the investigators, or involved institutions from their legal and professional responsibilities. You are free to withdraw from the study at any time.

CONTACT INFORMATION
If you have questions about taking part in this study, contact:
Angelina Singson at (905) 926-2707

If you have questions about your rights as a participant or about ethical issues related to this study, contact:
Lakeridge Health Research Ethics Board at (905) 576-8711 ext. 32745
or
Ontario Tech University Research Ethics Board at (905) 721-8668 ext. 3693