NCT03892993

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
27mo left

Started Apr 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress76%
Apr 2019Aug 2028

First Submitted

Initial submission to the registry

February 21, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 27, 2019

Completed
13 days until next milestone

Study Start

First participant enrolled

April 9, 2019

Completed
9.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2028

Last Updated

January 9, 2026

Status Verified

January 1, 2026

Enrollment Period

9.3 years

First QC Date

February 21, 2019

Last Update Submit

January 7, 2026

Conditions

Thyroid Gland Medullary Carcinoma

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    Up to 1 year post

Study Arms (1)

Supportive care (decision aid)

EXPERIMENTAL

Participants use decision aid and complete questionnaires.

Other: Decision AidOther: Questionnaire Administration

Interventions

Decision AidOTHER

Use decision aid

Supportive care (decision aid)
Questionnaire AdministrationOTHER

Ancillary studies

Supportive care (decision aid)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Individuals with cognitive or psychological impairment (e.g., depression, anxiety, severe mental illness; as documented in the registry)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Carcinoma, Medullary

Interventions

Decision Support Techniques

Condition Hierarchy (Ancestors)

Carcinoma, NeuroendocrineNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms, Ductal, Lobular, and MedullaryNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Elizabeth G Grubbs, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth G Grubbs, MD

CONTACT

(713) 792-0665eggrubbs@mdanderson.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2019

First Posted

March 27, 2019

Study Start

April 9, 2019

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

August 1, 2028

Last Updated

January 9, 2026

Record last verified: 2026-01

Locations

US(1)