We are recruiting 72 men with prostate cancer to participate in a study to examine the effect of androgen deprivation therapy on sleep and cognitive functioning in men with prostate cancer.
This research is important because it will help us to understand how sleep before and during prostate 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 men 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, urinary symptoms, hot flashes, 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.
You will also be asked to wear an actigraph and record the details of your sleep for two weeks 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, 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 chemotherapy treatment.
If you are interested in this study, or unsure of whether you are eligible, please contact us at email@example.com 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: John Thoms, MD, FRCPC (Division of Oncology, Faculty of Medicine), Satya Challa, MPH (Newfoundland and Labrador SUPPORT Unit)
Supported by grants from the Division of Oncology
at Memorial University and the Beatrice Hunter
Cancer Research Institute (BHCRI)
This study is currently recruiting participants