Decision Aid for Gender Dysphoria

Enrolling by invitation at 1 trial location

Overseen By Lee K Brown

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Dartmouth-Hitchcock Medical Center

Disqualifiers: Focus group participants, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new online tool, the MaPGAS Decision Aid, designed to assist individuals considering gender-affirming surgeries, such as metoidioplasty and phalloplasty, in making informed decisions. The trial aims to determine if the tool is user-friendly and if it reduces uncertainty and improves readiness for surgery compared to usual care. Participants will either use this decision aid or receive standard information and will provide feedback on their experience. It is suitable for those who identify as transgender male or gender non-binary, speak English, and have a consultation scheduled for these surgeries in the U.S. As an unphased trial, it offers a unique opportunity to contribute to developing a tool that could enhance decision-making for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this decision aid is safe for use in decision-making for gender-affirming surgery?

Research shows that decision aids, like the one tested in this trial, are generally safe and easy to use. These tools help people make informed choices by clearly explaining surgical options, risks, and benefits. They are not medical treatments, so they don't carry the same safety concerns as medications or surgeries.

Studies have found that decision aids can improve decision-making without causing harm. They focus on helping individuals understand their options and feel more confident before deciding about surgery. In this trial, the decision aid includes educational materials and stories from other patients, making it a supportive tool rather than a treatment with physical side effects.

Previous studies on similar decision aids for gender-affirming surgeries have shown positive results in helping people feel more prepared and certain about their choices. Overall, using a decision aid is considered a safe way to support decision-making for those considering gender-affirming surgeries like metoidioplasty and phalloplasty. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the MaPGAS Decision Aid because it offers a unique, web-based tool designed to assist individuals with gender dysphoria in making informed decisions about their surgical options. Unlike traditional methods that typically involve standard information brochures, this decision aid provides interactive components, educational materials, and patient testimonials, offering a more personalized and engaging experience. This innovative approach aims to empower patients with comprehensive knowledge, potentially leading to better-prepared consultations and more satisfied decision-making outcomes.

What evidence suggests that this decision aid is effective for reducing uncertainty and improving readiness for surgery?

Research shows that individuals considering metoidioplasty and phalloplasty often feel unsure about their decision. In this trial, participants in the MaPGAS Decision Aid Intervention arm will access a novel, web-based decision aid designed to reduce uncertainty by providing clear information and support. Studies have found that decision aids can improve conversations with healthcare providers and help individuals feel more prepared to make decisions. Early evidence suggests that this new online tool could help individuals better understand their surgical options and feel more confident about their choices. ^{1 3 6 7 8}

Who Is on the Research Team?

Rachel A. Moses, MD, MPH

Principal Investigator

Dartmouth-Hitchcock Clinic

Are You a Good Fit for This Trial?

This trial is for transgender individuals considering gender-affirming surgeries, specifically metoidioplasty and phalloplasty. Participants should be in the decision-making process regarding these surgeries and willing to provide feedback on a new online decision aid tool.

Inclusion Criteria

Able to speak, read, and understand English at a sixth-grade level

Resides in the USA

I identify as a transgender male or gender non-binary.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Intervention

Participants are randomly assigned to either receive usual care or test the web-based decision aid. They will provide feedback on the tool's usability and its helpfulness in supporting decision-making.

4 weeks

Unlimited access to decision aid

Follow-up

Participants are monitored for changes in decisional conflict and decision readiness after using the decision aid.

2-4 weeks

Post-surgical Consultation

Participants' shared decision-making experiences are assessed using the CollaboRATE score after their surgical consultation.

Within 1 week

What Are the Treatments Tested in This Trial?

Interventions

• MaPGAS Decision Aid

Trial Overview The study tests an online tool designed to help with decisions about Metoidioplasty and Phalloplasty Gender Affirming Surgery (MaPGAS). It compares the experiences of those using this tool against those receiving standard care, focusing on user-friendliness and its impact on surgery readiness.

How Is the Trial Designed?

Group I: MaPGAS Decision Aid Intervention Experimental Treatment 1 Intervention

Participants in this arm will be provided with access to a novel, web-based decision aid designed for individuals considering MaPGAS. The decision aid includes interactive components, educational materials regarding surgical options, risks, benefits, and patient testimonials. Participants will have unlimited access to the decision aid for four weeks prior to their surgical consultation.

Group II: MaPGAS Usual Care Active Control 1 Intervention

Participants in this arm will receive the standard pre-consultation care provided by their healthcare provider, which does not include access to the novel decision aid. Standard care may include informational brochures. This group serves to compare the outcomes of traditional decision-making processes with those who use the decision aid.

Who Is Running the Clinical Trial?

Dartmouth-Hitchcock Medical Center

Lead Sponsor

Trials

548

Recruited

2,545,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Dartmouth College

Collaborator

Trials

93

Recruited

1,415,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

University of Utah

Collaborator

Trials

1,169

Recruited

1,623,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11139465/

Exploring Decisional Conflict Experienced by Individuals ... A cross-sectional national sample of individuals considering MaPGAS showed higher decisional conflict amongst those considering both MaPGAS options.

2. researchgate.net researchgate.net/publication/388452799_New_insights_into_the_goals_of_transgender_male_versus_non-binary_individuals_considering_metoidioplasty_and_phalloplasty_gender-affirming_surgery

New insights into the goals of transgender male versus non ... Strengths and Limitations This is the largest study to our knowledge evaluating patient MaPGAS goals and comparing gender identity cohorts. Our results ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10311073/

Decision making in metoidioplasty and phalloplasty gender ... This study increases understanding of the factors important to MaPGAS decision making, and results are being used to guide development of a ...

4. meddatax.com meddatax.com/clinical-trials/NCT06565663

MaPGAS Decision Making This study aims to evaluate the usability, acceptability, and preliminary efficacy of a novel, web-based decision aid (DA) for Metoidioplasty ...

5. tandfonline.com tandfonline.com/doi/full/10.1080/26895269.2024.2440853?af=R

Decision-making in feminizing genital gender-affirming ... Both our quantitative and qualitative data suggest that the introduction of a decision-aid could enhance the quality of clinical interaction in ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12308307/

The core outcome set for studies on feminizing genital ... However, data synthesis of this outcome can provide valuable information on the overall outcomes of gender-affirming healthcare and gGAS.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8261453/

A systematic review of decision aids for gender affirming ... For inclusion in our systematic review to identify studies that detail the development or evaluation of a patient decision aid for gender dysphoria or gender ...

8. researchgate.net researchgate.net/publication/370732436_Decision_making_in_metoidioplasty_and_phalloplasty_gender-affirming_surgery_a_mixed_methods_study

Decision making in metoidioplasty and phalloplasty gender ... Conclusions This study increases understanding of the factors important to MaPGAS decision making, and results are being used to guide development of a patient- ...