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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

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ClinicalTrials.gov Identifier: NCT03892993
Recruitment Status : Recruiting
First Posted : March 27, 2019
Last Update Posted : February 10, 2022
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Thyroid Gland Medullary Carcinoma Other: Decision Aid Other: Questionnaire Administration Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

I. 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.

OUTLINE:

Participants use decision aid and complete questionnaire.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Actual Study Start Date : April 9, 2019
Estimated Primary Completion Date : April 19, 2023
Estimated Study Completion Date : April 19, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Supportive care (decision aid)
Participants use decision aid and complete questionnaires.
 Other: Decision Aid
Use decision aid

Other: Questionnaire Administration
Ancillary studies


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Individuals with cognitive or psychological impairment (e.g., depression, anxiety, severe mental illness; as documented in the registry)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03892993


Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Elizabeth G. Grubbs    713-792-6940    eggrubbs@mdanderson.org   
Principal Investigator: Elizabeth G. Grubbs         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Elizabeth G Grubbs M.D. Anderson Cancer Center
More Information
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Additional Information:

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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03892993    
Other Study ID Numbers: 2018-0557
NCI-2019-00631 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2018-0557 ( Other Identifier: M D Anderson Cancer Center )
First Posted: March 27, 2019    Key Record Dates
Last Update Posted: February 10, 2022
Last Verified: January 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Thyroid Neoplasms
Carcinoma, Medullary
Thyroid Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Carcinoma, Neuroendocrine
 Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms, Ductal, Lobular, and Medullary
Neoplasms, Nerve Tissue