This study is currently recruiting participants
We are recruiting 72 premenopausal women to participate in a study looking at the impact of chemotherapy on sleep, thinking, and memory problems in women who receive treatment for breast cancer. We are also interested in seeing how levels of the female hormone, estradiol, relates to sleep and thinking troubles.
This research is important because it will help us to understand how sleep before and during breast cancer treatment might influence the development of other side effects such as difficulty remembering things and paying attention. This information may be used to help develop targeted prevention and/or intervention programs to help other women in the future.
You may be eligible to participate if you meet the following criteria:
You may not be eligible if you have:
What does this study involve?
Participation in this study involves completing four assessments of sleep, thinking and memory, and emotional wellbeing over the next twelve months at a place of your convenience (pre-treatment, 4, 8, and 12 months). The total time to complete each assessment is estimated to be 40-60 minutes. These assessments can be conducted via telehealth if distance or transportation to St. John's is an issue.
You will also be asked to wear an actigraph and record the details of your sleep for one week following each assessment. An actigraph is a wrist-worn device similar to a watch that can record activity levels throughout the day and night. Recording your sleep details is estimated to take approximately 3 minutes per day. You will be given a stamped, self-addressed envelope to return the sleep diaries and actigraph by mail.
The researcher will assess your verbal learning and memory by asking you to recall lists of words. You will also complete some questionnaires assessing memory, attention, concentration, sleep, fatigue, hot flashes, and mood symptoms.
Taking part in this study is voluntary. It is up to you to decide whether to be in the study or not. If you decide to take part, you are free to leave at any time. This will not affect your normal treatment. Should you wish to participate, it important that you contact us before you are scheduled to start your cancer treatment.
If you are interested in this study, or unsure of whether you are eligible, please contact us at firstname.lastname@example.org so we can determine help you decide whether participation is right for you.
Primary Investigator: Sheila N. Garland, PhD (Department of Psychology, Faculty of Science and Division of Oncology, Faculty of Medicine)
Co-Investigators: Kara Laing, MD, FRCPC (Division of Oncology, Faculty of Medicine), Joy McCarthy, MD, FRCPC (Division of Oncology, Faculty of Medicine), Melanie Seal MD, FRCPC (Division of Oncology, Faculty of Medicine), Gerard Farrell, MD (Division of Family Medicine, Faculty of Medicine)
Students: Kayla Wall, BSc, Samantha Scurrey, BA, Nicole Rodriguez, BSc
Supported by a grant from Memorial University