A Survey About Trade-offs When Choosing Menopause Treatments

Study Overview
=================
Brief Summary
-----------------
This study is an online survey of women in menopause with moderate to severe hot flashes. Menopause, a normal part of life, is the time after a woman's last period. Hot flashes often occur during menopause. They can disrupt a woman's daily life. This study is about collecting information only. There will be no treatment in this study. This study will provide information on the trade-offs women are willing to make when deciding which treatment or treatments work best for them. Women from Australia, Canada, Denmark, France, Germany, Italy, Spain, Sweden and the United Kingdom (UK) will take part in this study. Women will be recruited through a third-party recruitment company. Most women will be asked to complete an online survey. Before the survey is sent to the women in the study, it will be tested by a small group of women. This group will be asked to take part in a telephone interview while taking the survey. They will be asked to say their thoughts aloud while completing the survey. Researchers will record this and also take notes. The aim of the interview is to check that the survey is understood by the women before it is sent out to the rest of the women. The survey will have 3 sections: Firstly, the women will answer questions about their experience with menopause and their symptoms. Next, they will be shown pros and cons for specific treatments for their menopause symptoms. The women will be asked to choose which treatment they would prefer, based on this information. Finally, they will answer questions on how their menopause symptoms have impacted their lives.

Official Title
-----------------
Women's Treatment Preferences for Moderate to Severe Vasomotor Symptoms (VMS) (WARMER Study)

Conditions
-----------------
Moderate to Severe Vasomotor Symptoms

Intervention / Treatment
-----------------
* Other: No Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Resident of Australia, Canada, Denmark, France, Germany, Italy, Spain, Sweden, or the United Kingdom Experience at least 14 moderate or severe VMS episodes associated with menopause per week (or 2 to 3 episodes per day) Self-reported completion of natural menopause (post-menopausal) Willing and able to provide consent to take part in the study; Speak native language of country of participation Telephone interview only: Willing and able to participate in a telephone interview, and be audio recorded Exclusion Criteria: Experienced treatment related menopause either as a result of medical or surgical intervention Difficulty understanding or communicating in the language(s) of Australia, Canada, Denmark, France, Italy, Spain, Sweden, or the United Kingdom Online survey only: Participation in the Telephone interview

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| post-menopausal women<br>post-menopausal women with moderate to severe VMS associated with menopause | Other: No Intervention<br>* This is a non-product related survey.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Part-worth utilities for each treatment attribute | The effect of changes in each attribute on preferences. Participants' preferences for Vasomotor Symptoms (VMS) treatment attributes will be collected via a discrete choice experiment (DCE). Participants will be asked to choose their preferred option among two treatments or no treatment. Negative part-worth utility indicates less desired levels and positive part-worth utility indicates more desired levels of attributes. | 1 day (once through survey) | 
| Relative attribute importance scores | Relative attribute importance scores will be derived from part-worth estimates and measure the maximum percentage contribution to a preference that relates to a change in each attribute. | 1 day (once through survey) | 
| Maximum acceptable risk | Maximum acceptable risk will be derived from part-worth estimates and measures how much risk (i.e., for each included risk) participants are willing to accept for a one-unit change in each other attribute. | 1 day (once through survey) | 
| Minimum acceptable benefit | Minimum acceptable benefit will be derived from part-worth estimates and measures the minimum acceptable reduction in the frequency of VMS for a unit change in each other attribute. | 1 day (once through survey) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimated probability that a specific treatment profile will be chosen | A set of treatment profiles will be generated using the attributes included in the discrete choice experiment (DCE). The probability of each profile being selected will be calculated. | 1 day (once through survey) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
menopause, vasomotor symptoms