The Effect of an App-based Intervention on Quality of Life in Patients With Endometriosis. (MASQUE)

February 11, 2025 updated by: Insel Gruppe AG, University Hospital Bern

A Mobile Application as Supportive Treatment of Endometriosis: the Effect on Quality of Life and Endometriosis-associated Pain. A Randomized Controlled Trial.

The goal of this clinical trial is to learn if an App-based intervention affects the quality of life in patients with suspected or confirmed endometriosis. The main questions it aims to answer are:

  • Does the App-based intervention improve the quality of life?
  • Does it lead to pain relief? Researchers will compare participants using the App to a control group to see if the App works to improve quality of life and endometriosis-related symptoms.

Participants will:

  • Use an App-based intervention or be in the control group (no App-use) for 6 months
  • Visit or have a telephone consultation after 3 and 6 months
  • Complete a questionnaire to assess the quality of life at inclusion, after 1, 3 and 6 months

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
308

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Switzerland
      • Bern, Switzerland, 3010
        • Recruiting
        • Department of Gynecology and Obstetrics, Women's University Hospital, Inselspital Bern, University of Bern
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Informed Consent as documented by signature
  • Age 18 or older
  • Premenopausal status (menopause is defined as amenorrhea lasting one year or longer)
  • Endometriosis, confirmed by surgery or clinically suspected
  • Possession of a smartphone

Exclusion Criteria:

  • Planned endometriosis surgery or planned hormonal therapy in the study period
  • Surgery and/or new hormonal therapy in the last three months
  • Malignant diseases
  • Pregnancy
  • Breastfeeding
  • Active desire for pregnancy in the study period
  • Fertility treatment
  • Simultaneous participation in other intervention studies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention group with histologically confirmed endometriosis
Device: NALU Endo Flow App
NALU Endo Flow App is a mobile application for women with endometriosis. The App provides educational information through videos, audios, and texts. Women learn about endometriosis in general with its symptoms, diagnosis, and therapy options such as lifestyle and mindset modification, endometriosis-specific diets, physical and mindfulness exercises. The App includes a diary to track the menstrual cycle and symptoms. Furthermore, access to a WhatsApp community of people with endometriosis is provided and a peer-group call is performed once monthly, as well as one additional monthly Q&A (Question&Answer) call moderated by certified health coaches.
No Intervention: Control group with histologically confirmed endometriosis
Experimental: Intervention group with clinically suspected endometriosis
Device: NALU Endo Flow App
NALU Endo Flow App is a mobile application for women with endometriosis. The App provides educational information through videos, audios, and texts. Women learn about endometriosis in general with its symptoms, diagnosis, and therapy options such as lifestyle and mindset modification, endometriosis-specific diets, physical and mindfulness exercises. The App includes a diary to track the menstrual cycle and symptoms. Furthermore, access to a WhatsApp community of people with endometriosis is provided and a peer-group call is performed once monthly, as well as one additional monthly Q&A (Question&Answer) call moderated by certified health coaches.
No Intervention: Control group with clinically suspected endometriosis

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Life quality
Time Frame: 6 months
The primary endpoint will be the change in quality of life in App users assessed by the EHP-30 questionnaire (Endometriosis-Health-Profile-Questionnaire: The questions can be divided into five subscales covering 'pain', 'control and powerlessness', 'social support', 'emotional wellbeing' and 'self-image'. The questionnaire is standardized on a scale from 0 to 100, with lower scores indicating better quality of life.
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pain relief
Time Frame: 6 months
The secondary endpoint of this study is the change in pain intensity in App users measured by the VAS (Visual Analogue Scale). The VAS is one of various instruments to measure pain intensity. A score of 0 means "no pain", a score of 10 "the worst imaginable pain".
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Insel Gruppe AG, University Hospital Bern

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marietta Gulz, MD, University Hospital Bern, Insel Gruppe AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 6, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023-D0105

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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