PERCEIVE Study: Insight into the patient experience of VMS
Research type
Research Study
Full title
PERCEIVE Study: Insight into the patient experience of VMS: exit interviews from the DAYLIGHT Phase 3b trial
IRAS ID
319415
Contact name
Betsy Williams
Contact email
Sponsor organisation
Astellas Pharma Global Development, Inc.
Clinicaltrials.gov Identifier
1004019, IRAS for DAYLIGHT Clinical Trial (Source for PERCIEVE study exit interview participants)
Duration of Study in the UK
0 years, 11 months, 29 days
Research summary
Summary of Research
The purpose of this non-interventional interview study is to learn about participants' experiences with severe vasomotor symptoms (hot flashes) before treatment and to learn about how the study medicine they took during the DAYLIGHT clinical trial impacted their experience. Participants at selected clinical sites will be told that they are eligible to be interviewed after the end of treatment study visit and will sign an informed consent form with site staff authorizing the transfer of contact information for interview scheduling. The 60 minute telephone interview will be scheduled at a time convenient for the participants and will be audio-recorded with verbal consent. The interview questions will focus on the patient experience with hot flashes both before and during the DAYLIGHT trial and will also ask about unmet needs or other concerns related to treatment for hot flashes. The transcripts from the interviews will be reviewed to ensure that any patient identifying information is removed and that the data is anonymized before analysis. The transcripts will be reviewed using qualitative analysis software and participant responses will be categorized and summarized in a final report. Results of the study are expected to provide insight into the patient experience of hot flashes (severity, frequency, bother associated) as well as understanding about how the study medicine may have impacted this symptom. Results will contribute to the scientific understanding of this condition and increase the canon of evidence to support the importance of treatment of hot flashes for women who are not eligible to use hormone treatment.
Summary of Results
A total of 10 patients in the UK were interviewed upon their exit from the Astellas DAYLIGHT clinical trial and asked about their experiences of VMS as it related to menopause. These patients reported a number of signs and symptoms in response to moderator questions, and these concepts are being developed into a preliminary conceptual model describing the patient experience of VMS.
REC name
East of England - Essex Research Ethics Committee
REC reference
22/EE/0240
Date of REC Opinion
17 Oct 2022
REC opinion
Further Information Favourable Opinion