Letter of Information and Consent Form

Please read the consent form below before continuing. To download it, click this link to open a downloadable version in a new tab

An Investigation of Self-Guided Activities for Reducing Distress for Women Diagnosed with Breast Cancer

Researchers:  

Ms. Kaylee Dyall, Acadia University 

Dr. Stéphanie Gauvin, Acadia University 

Chair of the Research Ethics Board: 

Dr. Stephanie Jones (stephanie.jones@acadiau.ca), Acadia University 

Purpose of the Study: 

You are being invited to participate in a research study that will evaluate the effectiveness of brief, online, and self-directed activities for reducing distress and improving well-being for women diagnosed with breast cancer. We are evaluating two different types of activities that have shown evidence of being effective at reducing distress and improving mental health. Our goal is to identify brief activities that are effective so we can create free and publicly available resources to better support women who are diagnosed with breast cancer. 

Study Eligibility:

In order to participate, you must identify as a woman, live in Canada, be 18 years of age or older, have breast cancer or have had it in the past, be experiencing cancer-related distress, and be able to read English fluently. 

Study Procedures:

If you would like to participate, you will be asked to complete a brief screening survey that we expect will take approximately 5-10 minutes. It will include questions about your demographic background (e.g., age, gender, ethnicity), your breast cancer diagnosis (e.g., diagnosis type, duration), and your accessibility to care. We will also ask for your contact information (e-mail and phone number) so that we can send you the full study and clarify any questions we may have from your screening survey responses. Please note that our calls will come from a blocked/no caller ID. To keep your data anonymous, your contact information will be stored separately from your survey responses, to do this we will automatically assign you a random alpha numeric code to anonymously link your screening survey responses to your responses in the full study. Your contact information will be deleted after you have completed the study.

If you are eligible to participate in the full study, it will be completed online in two parts. Part 1 will take approximately 20-30 minutes to complete and includes a pre-survey, a brief activity, and a post-survey. Following part 1, you will be asked to engage in brief activities (lasting approximately 5 minutes) for four weeks. As we know there are benefits to daily practice, we will recommend that you complete an activity daily, but we also know that individuals are often busy or may not always have the energy or desire to complete these activities, so we ask that you complete them as often as you are able. After four weeks, you will receive an e-mail with the part 2 follow-up survey, which will take approximately 5-10 minutes to complete.

Your participation in this study is completely voluntary and you can decline to participate in the research at any time by following the discontinue instructions below or skipping any questions you would not like to answer by selecting “Prefer not to answer”.

Risks and Benefits: 

There are no known physical, psychological, economic, or social risks or benefits associated with participating in this screening survey. If you are eligible and choose to participate in the full study, you may experience mental health benefits (e.g., reduced anxiety or distress) through participating in the brief activities. Further, participation in the full study will help inform the development of accessible mental health resources for other women with breast cancer. By providing consent to participate in the study, you do not waive rights to legal recourse if you experience research-related harms. 

Compensation:

You will not receive compensation for participating in this screening survey. Individuals who complete the part 2 follow-up survey will receive $5. We will also be conducting brief interviews with some participants after the follow-up survey. If you are selected for an interview and participate you would receive an additional $20. Further information about compensation will be provided in the full study consent form or is available upon request.

Please note that you must meet study screening criteria to participate in the study and receive compensation. If it is discovered that you have misrepresented your eligibility to participate in this study or provided false responses, you will not receive compensation. We will screen all data for legitimacy before compensation is sent which will include examining survey and interview responses.

Discontinuation of this Study: 

Your participation is voluntary, and you can decline to participate in the survey or any aspect of the research at any time without penalty or you may refuse to answer any of the questions that you are asked without providing an explanation for your refusal to answer. Should you wish to withdraw from the study, you can do so at any time by either closing the browser window or skipping the remaining questions by selecting “Prefer not to answer”. Please note that skipping questions may affect your eligibility to participate in the full study. If you provide your e-mail address and/or phone number in the screening survey, you can withdraw your data within 2 weeks of participating by e-mailing Kaylee Dyall (kayleedyall@acadiau.ca). If you do not provide your e-mail address and/or phone number, we will have no way of knowing which data is yours and therefore would not be able to remove it. To opt-out of e-mail notifications and reminders please e-mail Kaylee Dyall.

Anonymity and Confidentiality:  

You will be assigned a random alpha-numeric code that will link your survey responses to your contact information so that your survey responses are not directly linked to your contact information. Your contact information will only be used for study-related purposes (e.g., e-mailing out the survey) and will be deleted once you have completed the study (or withdrawn). Please note that e-mails are sent through our survey system and are not linked to your survey responses.

Your participation in this study is strictly confidential. The investigators will take all reasonable measures to protect the confidentiality of your records and your confidentiality will be protected to the extent permitted by applicable laws. 

You will not be identified in any publication or reports of this research, direct quotations may be used in findings, reports, and publications but no identifying information will be used. All electronic information collected through LimeSurvey will be stored on our secure servers at Acadia University (Wolfville, Nova Scotia, Canada). As the data is stored on Acadia University servers, technology services employees at Acadia University will have access to the data as required to perform their job duties.  

Please note that under certain circumstances, domestic or foreign authorities may legally access data sent or stored electronically. Should you complete the survey on a public computer, it is possible that others may have access to your responses. For example, if you complete the responses at work, your employer may have access to your responses. Your employer may have a legal right to access any information sent using employer-owned equipment. As such, you may wish to complete the survey using your personal equipment. 

Please note, under the Nova Scotia Children and Family Services Act, the research team has a legal obligation to break confidentiality, if needed, to report any suspicion of child abuse or neglect. 

Dissemination of Results:  

It is anticipated that the results of this study will be shared with others in the following ways: 1) conference oral and poster presentations; 2) press-releases and social media; and 3) peer-reviewed journal articles. In the course of dissemination, it is necessary to share anonymized data, in order for external reviewers and readers to verify the accuracy of our analyses and research reports. This will be facilitated via Kaylee Dyall and Dr. Gauvin’s Open Science Framework page — a service for sharing research materials. Data from this study will be stored indefinitely (on Canadian servers), in order to maintain the verifiability of the findings to interested researchers and readers. 

Funding Disclosure and Conflicts of Interest:

This project is funded by Research Nova Scotia (New Health Investigator award and Scotia Scholars award).

The researchers have no conflicts of interest to declare.

Consent:

By clicking “Yes, I have read and understand the above statements and freely consent to participate in this research”, I consent to the information listed above and understand what is required for participation in the survey. If I do not wish to consent, I understand that I can close my browser now. I also understand that researchers are available by e-mail should I have any questions or require further information about any aspect of the study. I understand that my participation in the study is completely voluntary and that I am free to withdraw at any time. I understand that to withdraw from the study, I may skip any and all remaining questions by selecting “Prefer not to answer”. I also understand that my confidentiality will be protected throughout the study and that the information I provide will be available only to researchers with relevant scholarly interests.  

Should I have further questions, I understand that I can contact any of the following individuals: 

For questions related to the study or the research goals: 

Kaylee Dyall (kayleedyall@acadiau.ca), Master’s Student, Department of Psychology, Acadia University 

Dr. Stéphanie Gauvin (stephanie.gauvin@acadiau.ca), Assistant Professor, Department of Psychology, Acadia University 

Note: If you would like to arrange a phone call with the researchers, please e-mail them to schedule a call.

For questions related to ethical considerations: 

Acadia Research Ethics Board Chair: Dr. Stephanie Jones 

E-mail: stephanie.jones@acadiau.ca  

Telephone: 1-902-585-1407 

Mail: 214 Horton Hall, Acadia University, Wolfville, Nova Scotia, Canada, B4P 2R6 (1-902-585-1407) 

*Please note that it is advised that you print or save this consent form for your records and/or record the researcher’s contact information in the case that you have any questions or concerns. To download the consent form, click this link to open a downloadable version in a new tab*