Procedures and protocol changes
telephone/video, sweats, breast cancer
ADVERSE EVENTS, SECONDARY, RECRUITMENT, BREAST CANCER
Initial on-site Vancouver recruitment was slow. Some women reported not wanting the hassle of appointments for clinical breast exams and mammograms. Therefore, we revised the protocol and obtained ethical and DSMC approval for remote participation which facilitated trans-Canadian recruitment. We obtained approval from Health Canada to remove the requirement for breast cancer screening. Safety and effectiveness measures included telephone/video conference screening interview and full baseline questionnaire; each remote participant personally signed for the couriered experimental medication. Study communications used email, secure fax, telephone or web-conferencing. Participants returned unused medications in a provided stamped return-addressed, padded postal envelope.With study enquiry, the coordinator spoke with the potential participant and provided her with the consent form. When each gave Participants initially recorded VMS in the Daily Perimenopause DiaryWe re-assessed trial eligibility using baseline-m VMS experiences. We randomized those remaining eligible (as described above) to experimental therapy for 3-m. We contacted participants monthly to assess their well-being, monitor adherence and systematically make open-ended inquiries about any adverse events. On the final day of experimental therapy, participants completed the secondary outcome, “Women’s Perceived Change Questionnaire”At RCT completion, participants returned completed Calendars, Women’s Perceived Change Questionnaire (inquiring about trial changes in hot flushes, night sweats, sleep quality and vaginal flow), repeated the PHQ-9, and the Perimenopausal Interference Questionnaire (see 