None listed
Conditions
Brief summary
Aim: This randomised controlled trial will assess the feasibility and acceptability of EndoOptions, a new co-designed online resource which aims to support people with endometriosis to make decisions about their symptom management. The mixed-methods trial will also assess whether EndoOptions (i) reduces decisional conflict, and (ii) improves emotional wellbeing, and will also explore whether decisional self-efficacy mediates these effects. Participants: N=150 (aged 18 or over, living in Australia, with a diagnosis of endometriosis or suspected of having endometriosis) will be recruited via the offices of obstetrician-gynaecologists and specialist Endometriosis and Pelvic Pain Clinics, then randomly assigned to the Intervention group or the Control group. Design: The Intervention group will receive access to EndoOptions immediately, while the Control group will receive access after three months. Individual links will enable researchers to examine back-end user statistics on site access and navigation, and participants will also be asked to fill out online questionnaires at baseline, 1 month, 3 months and 6 months. Participants who have completed the six-month survey will also be offered the chance to take part in a 30-minute interview to give more detailed feedback on EndoOptions. In recognition of their time, we will be offering all participants who complete the six-month trial a $50 honorarium. Outcome: It is hoped that participants report EndoOptions to be acceptable and feasible, and that EndoOptions reduces psychological conflict in relation to making decisions about endometriosis symptom management.
Interventions
EndoOptions is an online patient decision aid co-designed by consumers, clinicians and researchers to support shared decision-making in endometriosis symptom management. This web-based app gives text-based information about endometriosis and its symptom management options in an easy-to-digest manner, as well as providing a values clarification exercise to help users to work out what is important to them in managing their symptoms. EndoOptions also has video interviews with healthcare professiona
EndoOptions is an online patient decision aid co-designed by consumers, clinicians and researchers to support shared decision-making in endometriosis symptom management. This web-based app gives text-based information about endometriosis and its symptom management options in an easy-to-digest manner, as well as providing a values clarification exercise to help users to work out what is important to them in managing their symptoms. EndoOptions also has video interviews with healthcare professionals in the field, and podcast chats with people who have endometriosis recounting their experiences. The site has been designed in a way that steps users through its components, but it is modular, so they can focus on the management options that interest them. A comparison function allows users to compare the options they are interested in, and they can formulate an action plan that they can email to themselves. EndoOptions was developed in accordance with International Patient Decision Aid Standards (IPDAS). Participants will independently access EndoOptions via smartphone, tablet or computer web browser by following a personalised link. No guidance will be given about how long participants should spend looking at the site, or how often over the 6-month course of the trial. Back-end statistics will be examined to assess how many times each participant logs on, how long they spend on the site, and how they navigate through it. Participants will be randomly assigned to two conditions: the Intervention group will receive EndoOptions immediately for use alongside their usual healthcare. At the end of the six-month trial, a subset of participants (N=20) will be interviewed for more in-depth feedback on EndoOptions. An invite will be emailed to all participants who have completed the four online questionnaires, and purposive sampling based on demographic and clinical details will be used, with the aim of gathering a wide range of viewpoints (e.g. across age, place of location, education level, time since diagnosis; Fallon et al., 2025, https://doi.org/10.1080/08870446.2025.2502866). These semi-structured one-on-one interviews will be conducted online by a member of the research team. We anticipate that recruitment into the study will take up to 6 months, therefore the study including the post-trial interviews should be completed within 13 months.
Sponsors
Macquarie University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants will have to be aged 18 or older, with a diagnosis of endometriosis or suspected endometriosis, and living in Australia. They must be able to use the internet, and be able to read and write English. While endometriosis primarily affects biological women, we recognise that trans, non-binary, and gender-diverse people can have endometriosis so will not be specifying gender on our recruitment material.
Exclusion criteria
Anyone who does not satisfy the eligibility criteria outlined above.
Outcome results
None listed