Thyroid Gland Medullary CarcinomaNCT03892993
Patient Decision Aid in Supporting Decision-Making About When to Start or Stop New Drugs, Join Clinical Trials, or Continue Active Surveillance in Patients With Medullary Thyroid Cancer and Their Caregivers
A study testing Decision Aid and Questionnaire Administration in people with Thyroid Gland Medullary Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This trial develops and studies how well a patient decision aid works in supporting decision-making about when to start or stop new drugs, join clinical trials, or continue active cancer monitoring for patients with medullary thyroid cancer and their caregivers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Thyroid Gland Medullary Carcinoma
- What is being tested?
- Decision Aid and Questionnaire Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Apr 2019to 1 Aug 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18 years old or older
- Have or will face(d) this decision, including: Patient/survivor - who has medullary thyroid carcinoma, as determined by a clinician or documented in the Genetics of Endocrine Neoplasia Registry or sporadic (medullary thyroid carcinoma) MTC database; Caregiver/family member - of patient/survivor who has medullary thyroid carcinoma, as nominated by the patient/survivor; and Provider - who treats patients/survivors who have medullary thyroid carcinoma, as described above
- Able to speak, read, and write English
- Pregnant patients are included
Who cannot join
- --Individuals with cognitive or psychological impairment (e.g., depression, anxiety, severe mental illness; as documented in the registry)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
M D Anderson Cancer Center
Houston, Texas, 77030
Elizabeth G. Grubbs, 713-792-6940, eggrubbs@mdanderson.org
Elizabeth G. Grubbs
About this study
Official title: Designing a Decision Aid to Help People With Medullary Thyroid Cancer Make Decisions With Their Doctors About Whether to Start or Stop New Drugs, Enroll in Clinical Trials, or Continue With Active Surveillance
This trial develops and studies how well a patient decision aid works in supporting decision-making about when to start or stop new drugs, join clinical trials, or continue active cancer monitoring for patients with medullary thyroid cancer and their caregivers. Developing a patient decision aid may help patients with medullary thyroid cancer make well-informed decisions about their cancer care and be able to discuss their preferences with their doctors.
Read the detailed description
PRIMARY OBJECTIVES:
- To assess patient/survivor, caregiver/family member, and provider decision-making needs.
II. To design and develop an initial patient decision aid prototype. III. To pilot test its acceptability. IV. To evaluate the acceptability and usability of the decision aid prototype from patients/survivors, caregivers and providers in a real world environment.
OUTLINE:
Participants use decision aid and complete questionnaire.
- Conditions
- Thyroid Gland Medullary Carcinoma
- Being tested
- Decision Aid, Questionnaire Administration
- Medical subject headings
- Carcinoma, Medullary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision AidOther
Use decision aid
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Supportive care (decision aid) | Experimental | Participants use decision aid and complete questionnaires. Receives: Other: Decision Aid; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Needs assessment
The research team will tabulate and summarize responses to the needs assessment questionnaire to identify priority design needs, and review open text areas for notable suggestions.
Measured: Up to 1 year
Decision aid design refining (storyboarding)
During storyboarding, the research team will iteratively review the interviewers' notes regarding participant feedback, identify predominant recommendations for improvement, and make decisions to refine the decision aid design.
Measured: Up to 1 year
Decision aid acceptability
The research team will review the Think Aloud interview notes for potential opportunities for improvement. Responses to the post-decision aid acceptability questionnaire will be tabulated and summarized into tables for publication and presentation using Excel. The Stakeholder Advisory Panel will review responses to the post-decision aid acceptability questionnaire, to confirm that viewing the decision aid provides a balanced presentation of the options and is not likely to bias patients'/survivors' initial preferences.
Measured: Up to 1 year post decision aid
Real World Evaluation
Responses to the participant characteristics will be tabulated and summarized for presentation and publication, as appropriate. The research team will tabulate and summarize responses to the needs assessment questionnaire to identify priority design needs and review open text areas for notable suggestions.
Measured: Up to 1 year post
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2019
- Study start9 Apr 2019
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid Gland Medullary CarcinomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Elizabeth G Grubbs, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03892993
- Sponsor's protocol ID
- 2018-0557
- Other IDs
- NCI-2019-00631, 2018-0557
- Status last verified
- Jul 2026
- First submitted
- 21 Feb 2019
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Designing a Decision Aid to Help People With Medullary Thyroid Cancer Make Decisions With Their Doctors About Whether to Start or Stop New Drugs, Enroll in Clinical Trials, or Continue With Active Surveillance
- ClinicalTrials.gov ID
- NCT03892993
- Acronym / sponsor ID
- 2018-0557
- Conditions
- Thyroid Gland Medullary Carcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 9 Apr 2019 (actual)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 27 Mar 2019 (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.
This trial develops and studies how well a patient decision aid works in supporting decision-making about when to start or stop new drugs, join clinical trials, or continue active cancer monitoring for patients with medullary thyroid cancer and their caregivers. Developing a patient decision aid may help patients with medullary thyroid cancer make well-informed decisions about their cancer care and be able to discuss their preferences with their doctors.
Detailed description
PRIMARY OBJECTIVES:
- To assess patient/survivor, caregiver/family member, and provider decision-making needs.
II. To design and develop an initial patient decision aid prototype. III. To pilot test its acceptability. IV. To evaluate the acceptability and usability of the decision aid prototype from patients/survivors, caregivers and providers in a real world environment.
OUTLINE:
Participants use decision aid and complete questionnaire.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (decision aid) | Experimental | Other: Decision Aid, Other: Questionnaire AdministrationParticipants use decision aid and complete questionnaires. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18 years old or older
- Have or will face(d) this decision, including: Patient/survivor - who has medullary thyroid carcinoma, as determined by a clinician or documented in the Genetics of Endocrine Neoplasia Registry or sporadic (medullary thyroid carcinoma) MTC database; Caregiver/family member - of patient/survivor who has medullary thyroid carcinoma, as nominated by the patient/survivor; and Provider - who treats patients/survivors who have medullary thyroid carcinoma, as described above
- Able to speak, read, and write English
- Pregnant patients are included
Key exclusion criteria (1 listed)
- --Individuals with cognitive or psychological impairment (e.g., depression, anxiety, severe mental illness; as documented in the registry)
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 |
|---|---|---|
| Decision AidUse decision aid | Other | Supportive care (decision aid) |
| Questionnaire AdministrationAncillary studies | Other | Supportive care (decision aid) |
Primary outcome
Needs assessment
Time frame: Up to 1 year
The research team will tabulate and summarize responses to the needs assessment questionnaire to identify priority design needs, and review open text areas for notable suggestions.
Decision aid design refining (storyboarding)
Time frame: Up to 1 year
During storyboarding, the research team will iteratively review the interviewers' notes regarding participant feedback, identify predominant recommendations for improvement, and make decisions to refine the decision aid design.
Decision aid acceptability
Time frame: Up to 1 year post decision aid
The research team will review the Think Aloud interview notes for potential opportunities for improvement. Responses to the post-decision aid acceptability questionnaire will be tabulated and summarized into tables for publication and presentation using Excel. The Stakeholder Advisory Panel will review responses to the post-decision aid acceptability questionnaire, to confirm that viewing the decision aid provides a balanced presentation of the options and is not likely to bias patients'/survivors' initial preferences.
Real World Evaluation
Time frame: Up to 1 year post
Responses to the participant characteristics will be tabulated and summarized for presentation and publication, as appropriate. The research team will tabulate and summarize responses to the needs assessment questionnaire to identify priority design needs and review open text areas for notable suggestions.
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 16 Jul 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
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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.
Elizabeth G Grubbs, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decision Aid and Questionnaire Administration in people with Thyroid Gland Medullary Carcinoma, run by M.D. Anderson Cancer Center at 1 site 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 4 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: looking for participants now, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact Elizabeth G Grubbs, MD ((713) 792-0665, eggrubbs@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Needs assessment (time frame: Up to 1 year). The study lists 4 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 16 Jul 2026.