Gender DysphoriaMaPSNCT06565663
Metoidioplasty and Phalloplasty Surgery Decision Making
A study testing MaPS Decision Aid in people with Gender Dysphoria and Gender Dysphoria, Adult, run by Dartmouth-Hitchcock Medical Center at 2 sites in United States.
Trial 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 Surgeries (MaPS) make informed decisions The main questions it aims to answer are: How user-friendly is the decision aid for individuals… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gender Dysphoria, Gender Dysphoria, Adult, Gender Incongruence
- What is being tested?
- MaPS Decision Aid
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 Oct 2024to 6 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Participants involved in the initial tool refinement focus groups cannot participate in the intervention or control group to avoid contamination of the study outcomes.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Dartmouth College
Hanover, New Hampshire, 03755
University of Utah
Salt Lake City, Utah, 84112
About this study
Official title: Risk -Benefit Decision Making in Metoidioplasty and Phalloplasty Surgeries (MaPS)
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:
Read more
- 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.
Read the 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 Surgeries (MaPS).
MaPS are increasingly performed, however, patients face complex decisions which may impact fertility, urinary and sexual function. Existing decisional uncertainty among individuals considering MaPS 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 MaPS picture DA prototype.
Cognitive interviews with both participants considering or post MaPS 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.
- Conditions
- Gender Dysphoria, Gender Dysphoria, Adult, Gender Incongruence, Transgenderism, Transsexualism, Transgender Persons
- Being tested
- MaPS Decision Aid
- 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
- Medical subject headings
- Gender Dysphoria, Transsexualism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MaPS Decision AidBehavioural
Also called Metoidioplasty and Phalloplasty Gender Affirming Surgery Web-Based Pictorial Decision Aid
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 group | Role | What they receive |
|---|---|---|
| MaPS Decision Aid Intervention | Experimental | Participants in this arm will be provided with access to a novel, web-based decision aid designed for individuals considering MaPS. 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. Receives: Behavioral: MaPS Decision Aid |
| MaPS Usual Care | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decisional Conflict Scale (DCS) Score Change
The Decisional Conflict Scale (DCS) is used to measure personal perceptions of uncertainty in choosing options, factors contributing to uncertainty such as feeling uninformed, unclear about personal values, and unsupported in decision making, and perceived effectiveness of decision making. A change in DCS scores from baseline (pre-decision aid exposure) to post-decision aid exposure will be assessed to determine the impact of the decision aid on reducing decisional conflict. Scores range from 0 [no decisional conflict] to 100 [extremely high decisional conflict].
Measured: Baseline (within 1-2 weeks prior to using the decision aid) and follow-up (immediately after decision aid use, approximately 2-4 weeks later).
Preparation for Decision Making (PrepDM) Scale Score Change
The Preparation for Decision Making (PrepDM) scale assesses a patient's perception of how useful a health-related decision aid is in preparing them to make a health decision. It evaluates the perceived helpfulness of the decision aid in understanding treatment options, clarifying personal values for the decision, and feeling prepared to talk with their health provider about the decision. The change in PrepDM scores before and after decision aid exposure indicates the aid's efficacy in improving decision readiness. Higher scores indicate higher perceived level of preparation for decision making.
Measured: 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 (2)
CollaboRATE Score Change Post-Surgical Consultation
The CollaboRATE score is a brief patient-reported measure assessing the extent of shared decision-making experienced during medical encounters. It focuses on three core aspects: the explanation of health issues, the elicitation of patient preferences, and the integration of these preferences into the decision-making process. A comparison of CollaboRATE scores between control and intervention groups after the surgical consultation will indicate the decision aid's impact on enhancing shared decision making. Higher scores represent more shared decision making; scores can range from 0-100.
Measured: Within one week following the surgical consultation.
System Usability Scale (SUS) Score
The System Usability Scale (SUS) Score is a reliable tool for measuring the usability of the web-based decision aid. It consists of a 10-item questionnaire with five response options for respondents ranging from 'Strongly agree' to 'Strongly disagree'. It is widely used in the domain of user experience and measures the overall perceived usability of the decision aid. Higher scores represent a higher perceived system usability; scores can range from 0-100.
Measured: Immediately after using the decision aid (approximately 2-4 weeks from baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start23 Oct 2024
- Primary completion2 Feb 2028 (estimated)
- Study completion6 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gender DysphoriaStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Utah, Dartmouth College, National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, Rachel A. Moses, Dartmouth-Hitchcock Medical Center
- Investigators
- Rachel A. Moses, MD, MPH, Principal investigator, Dartmouth-Hitchcock Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06565663
- Sponsor's protocol ID
- STUDY02002174
- Other IDs
- 1R01DK137994-01
- Acronym
- MaPS
- Status last verified
- Sep 2026
- First submitted
- 19 Jun 2024
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study plans to share de-identified individual participant data (IPD) that underlie the results reported in publications, as well as the data dictionaries defining each field in the set. Sharing these datasets will enable secondary analyses by other researchers, promoting transparency and accelerating knowledge discovery in the field of gender affirming surgeries. The shared IPD will include demographic information, responses to surveys, and outcome measures such as the Decisional Conflict Scale, Preparation for Decision Making Scale, CollaboRATE measure, and other relevant data collected throughout the study.
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk -Benefit Decision Making in Metoidioplasty and Phalloplasty Surgeries (MaPS)
- ClinicalTrials.gov ID
- NCT06565663
- Acronym / sponsor ID
- MaPS / STUDY02002174
- Conditions
- Gender Dysphoria, Gender Dysphoria, Adult, Gender Incongruence, Transgenderism, Transsexualism, Transgender Persons
- Keywords
- Gender-Affirming Surgery, Sex Reassignment Surgery, Gender Reassignment Surgery, Phalloplasty, Metoidioplasty, Transmasculine, FTM, Gender Dysphoria
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- University of Utah, Dartmouth College, National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 23 Oct 2024 (actual)
- Primary completion
- 2 Feb 2028 (estimated)
- Study completion
- 6 Mar 2028 (estimated)
- First posted
- 22 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 Surgeries (MaPS).
MaPS are increasingly performed, however, patients face complex decisions which may impact fertility, urinary and sexual function. Existing decisional uncertainty among individuals considering MaPS 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 MaPS picture DA prototype.
Cognitive interviews with both participants considering or post MaPS 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MaPS Decision Aid Intervention | Experimental | Behavioral: MaPS Decision AidParticipants in this arm will be provided with access to a novel, web-based decision aid designed for individuals considering MaPS. 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. |
| MaPS Usual Care | No 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 may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (1 listed)
- Participants involved in the initial tool refinement focus groups cannot participate in the intervention or control group to avoid contamination of the study outcomes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MaPS Decision AidAlso: Metoidioplasty and Phalloplasty Gender Affirming Surgery Web-Based Pictorial Decision AidThis 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. | Behavioural | MaPS Decision Aid Intervention |
Primary outcome
Decisional Conflict Scale (DCS) Score Change
Time frame: Baseline (within 1-2 weeks prior to using the decision aid) and follow-up (immediately after decision aid use, approximately 2-4 weeks later).
The Decisional Conflict Scale (DCS) is used to measure personal perceptions of uncertainty in choosing options, factors contributing to uncertainty such as feeling uninformed, unclear about personal values, and unsupported in decision making, and perceived effectiveness of decision making. A change in DCS scores from baseline (pre-decision aid exposure) to post-decision aid exposure will be assessed to determine the impact of the decision aid on reducing decisional conflict. Scores range from 0 [no decisional conflict] to 100 [extremely high decisional conflict].
Preparation for Decision Making (PrepDM) Scale Score Change
Time frame: Baseline (within 1-2 weeks prior to using the decision aid) and follow-up (immediately after decision aid use, approximately 2-4 weeks later).
The Preparation for Decision Making (PrepDM) scale assesses a patient's perception of how useful a health-related decision aid is in preparing them to make a health decision. It evaluates the perceived helpfulness of the decision aid in understanding treatment options, clarifying personal values for the decision, and feeling prepared to talk with their health provider about the decision. The change in PrepDM scores before and after decision aid exposure indicates the aid's efficacy in improving decision readiness. Higher scores indicate higher perceived level of preparation for decision making.
2 secondary outcomes
CollaboRATE Score Change Post-Surgical Consultation
Time frame: Within one week following the surgical consultation.
System Usability Scale (SUS) Score
Time frame: Immediately after using the decision aid (approximately 2-4 weeks from baseline)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: Yes. The study plans to share de-identified individual participant data (IPD) that underlie the results reported in publications, as well as the data dictionaries defining each field in the set. Sharing these datasets will enable secondary analyses by other researchers, promoting transparency and accelerating knowledge discovery in the field of gender affirming surgeries. The shared IPD will include demographic information, responses to surveys, and outcome measures such as the Decisional Conflict Scale, Preparation for Decision Making Scale, CollaboRATE measure, and other relevant data collected throughout the study.
Related trials for Gender Dysphoria
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
RecruitingObservational study
Comparative Study of Gender Identity Disorder Versus Control
Gender Dysphoria, Adult
RecruitingObservational study
China Gender-affirming Hormone Therapy Study
Transgender, Gender Incongruence
RecruitingObservational study
GLOW: Gender-Affirming Care and Mental Health: A Longitudinal Study On Quality of Life, Work Life, and Healthcare Outcomes
Gender Dysphoria, Adult
RecruitingObservational study
A European Network for the Investigation of Gender Incongruence
Physical and Psychological Evaluation of Hormonal Therapy in Transsexual Persons
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rachel A. Moses, MD, MPH principal investigator
Dartmouth-Hitchcock Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MaPS Decision Aid in people with Gender Dysphoria and Gender Dysphoria, Adult, run by Dartmouth-Hitchcock Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decisional Conflict Scale (DCS) Score Change (time frame: Baseline (within 1-2 weeks prior to using the decision aid) and follow-up (immediately after decision aid use, approximately 2-4 weeks later).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.