What this study is
The goal of this clinical trial is to test a new online tool designed to provide clear and understandable information to help individuals considering Metoidioplasty and Phalloplasty Surgeries (MaPS) make informed decisions
The main questions it aims to answer are:
- How user-friendly is the decision aid for individuals considering metoidioplasty and phalloplasty?
- Does using the decision aid reduce uncertainty and improve readiness for making surgery decisions compared to usual care?
Participants in this study will:
- Be randomly assigned to either 1) receive usual care or 2) test the web-based decision aid.
- Share their feedback on the tool's usability and its helpfulness in supporting decision-making.
- Complete surveys before and after using the decision aid to measure any changes in their decision-making process.
Researchers will compare participants who used the decision aid with those who received standard care to see if the decision aid reduces decisional uncertainty and improves readiness for surgery.
What's being tested
- MaPS Decision Aid
Intervention · BEHAVIORAL
This intervention involves a novel, web-based decision aid tool specifically designed to support transgender and non-binary individuals assigned female at birth in making informed decisions about Metoidioplasty and Phalloplasty Surgeries (MaPS). The tool includes comprehensive information on surgical options, risks, benefits, and medical illustrations to aid in aligning surgical decisions with the individual's personal values and goals.
Study details
- Official title
- Risk -Benefit Decision Making in Metoidioplasty and Phalloplasty Surgeries (MaPS)
- Sponsor
- Dartmouth-Hitchcock Medical Center
- Conditions
- Gender Dysphoria · Gender Dysphoria, Adult · Gender Incongruence · Transgenderism · Transsexualism · Transgender Persons · Phalloplasty
- Enrolling
- 140 people
- Starts
- 2024-10-23
- Est. completion
- 2028-03-06
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex FEMALEHealthy volunteers Not acceptedYou may qualify if
- Assigned female on the original birth certificate.
- Self-identifies as transgender male and/or gender non-binary.
- Able to speak, read, and understand English at a sixth-grade level.
- Aged 18 or older.
- Resides in the USA.
- For decision aid refinement: Considering metoidioplasty or phalloplasty, or is post-operative.
- For intervention and control arm: Has a consultation scheduled for metoidioplasty or phalloplasty.
You can't join if
- Participants involved in the initial tool refinement focus groups cannot participate in the intervention or control group to avoid contamination of the study outcomes.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (2)
2 openDartmouth College
Hanover, New Hampshire, United States
University of Utah
Salt Lake City, Utah, United States
Study team
Sponsor
Dartmouth-Hitchcock Medical Center
Study ID STUDY02002174
Principal investigator
Rachel A. Moses, MD, MPH
Dartmouth-Hitchcock Clinic
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.