Clinical trial NCT06565663: MaPGAS Decision Making
Official title: Decision Making in Metoidioplasty and Phalloplasty Gender Affirming Surgery (MaPGAS)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Gender Dysphoria
Gender Dysphoria, Adult
Gender Incongruence
Transgenderism
Transsexualism
Transgender Persons
Phalloplasty
Keywords: Gender-Affirming Surgery
Sex Reassignment Surgery
Gender Reassignment Surgery
Phalloplasty
Metoidioplasty
Transmasculine
FTM
Gender Dysphoria
Transgender
Penile Reconstruction
Female-to-Male
Neophallus
Transsexual
Genital Reconstruction
Reconstructive Urology
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: University of Utah
name: Dartmouth College
name: National Institutes of Health (NIH)
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2024-08-22
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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 Gender Affirming Surgery (MaPGAS)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.

Detailed description: This study aims to evaluate the usability, acceptability, and preliminary efficacy of a novel, web-based decision aid (DA) for Metoidioplasty and Phalloplasty Gender Affirming Surgeries (MaPGAS).

MaPGAS are increasingly performed to improve gender congruence and quality of life, however, patients face complex decisions which may impact fertility, urinary and sexual function. Existing decisional uncertainty among transgender and non-binary individuals considering MaPGAS highlights the need for effective decision support tools. Prior research indicates a gap in validated decision support, partly due to insufficient understanding of patient needs and a lack of published outcomes or guidelines. This study builds on preliminary work that identified key decision-making factors among patients and healthcare providers, leading to the development of a co-developed web-based MaPGAS picture DA prototype.

Cognitive interviews with both participants considering or post MaPGAS and healthcare providers will refine the decision tool. The study will also investigate the DA's implementation within clinical settings to understand optimal administration timing and its impact on shared decision-making processes.

This study will employ a mixed-methods approach and a prospective randomized controlled trial to assess the DA's usability and acceptability using the System Usability Scale and focus group feedback. Additionally, it aims to evaluate the DA's preliminary efficacy in reducing decisional conflict and improving decision readiness and shared decision-making quality compared to usual care. This will be measured using validated tools such as the Decisional Conflict Scale, Preparation for Decision Making Scale, and CollaboRATE measure, alongside semi-structured patient and provider interviews.

This research aims to addressing the decisional needs of transgender and non-binary individuals considering MaPGAS, aiming to empower them with the tools needed for making informed, value-congruent decisions regarding their surgical options.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Participants involved in the initial tool refinement focus groups cannot participate in the intervention or control group to avoid contamination of the study outcomes.

Primary outcomes:
measure: Decisional Conflict Scale (DCS) Score Change
timeFrame: Baseline (within 1-2 weeks prior to using the decision aid) and follow-up (immediately after decision aid use, approximately 2-4 weeks later).
measure: Preparation for Decision Making (PrepDM) Scale Score Change
timeFrame: Baseline (within 1-2 weeks prior to using the decision aid) and follow-up (immediately after decision aid use, approximately 2-4 weeks later).
Secondary outcomes:
measure: CollaboRATE Score Change Post-Surgical Consultation
timeFrame: Within one week following the surgical consultation.
measure: System Usability Scale (SUS) Score
timeFrame: Immediately after using the decision aid (approximately 2-4 weeks from baseline)
Other outcomes:
measure: Qualitative Feedback from Cognitive Interviews
timeFrame: Post-decision aid use, and post-surgical consultation (dates vary, approximately 2-6 weeks from baseline).
Locations:
city: Hanover
country: United States
facility: Dartmouth College
state: New Hampshire
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: Dartmouth-Hitchcock Clinic
name: Rachel A. Moses, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: