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

Insel Gruppe AG, University Hospital Bern

Status: Enrolling

Conditions: Quality of Life; Life Style; Endometriosis; Pain

Treatments: Device: NALU Endo Flow App

Study type: Interventional

Funder types: Other

Identifiers

NCT06821217

2023-D0105

Details and patient eligibility

About

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

Enrollment: 308 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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308 participants in 4 patient groups

Intervention group with histologically confirmed endometriosis

Experimental group

Treatment:

Device: NALU Endo Flow App

Control group with histologically confirmed endometriosis

No Intervention group

Intervention group with clinically suspected endometriosis

Experimental group

Treatment:

Device: NALU Endo Flow App

Control group with clinically suspected endometriosis

No Intervention group