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

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: Recruiting
• Conditions: Quality of Life; Pain; Endometriosis; Life Style
• Intervention / Treatment: Device: NALU Endo Flow App

• Study Type: Interventional
• Enrollment (Estimated): 308
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marietta Gulz, MD; Phone Number: +41 31 632 10 10; Email: marietta.gulz@insel.ch
• Study Contact Backup: Name: Michael David Mueller, Professor, MD; Email: michel.mueller@insel.ch

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Recruiting
    • Department of Gynecology and Obstetrics, Women's University Hospital, Inselspital Bern, University of Bern
    • Contact: Michael Mueller, Professor, MD; Phone Number: +41 31 632 10 10; Email: michel.mueller@insel.ch

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Life quality	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

Outcome Measure	Measure Description	Time Frame
Pain relief	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

• Sponsor: Insel Gruppe AG, University Hospital Bern
• Investigators: Principal Investigator: Marietta Gulz, MD, University Hospital Bern, Insel Gruppe AG

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: February 6, 2025
• First Submitted That Met QC Criteria: February 6, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 11, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Endometriosis
• Other Study ID 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