Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03892993
Other study ID # 2018-0557
Secondary ID NCI-2019-0063120
Status Recruiting
Phase N/A
First received
Last updated
Start date April 9, 2019
Est. completion date August 1, 2028

Study information

Verified date February 2024
Source M.D. Anderson Cancer Center
Contact Elizabeth G Grubbs, MD
Phone (713) 792-0665
Email eggrubbs@mdanderson.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date August 1, 2028
Est. primary completion date August 1, 2028
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 - Pregnant patients are included Exclusion Criteria: --Individuals with cognitive or psychological impairment (e.g., depression, anxiety, severe mental illness; as documented in the registry)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Decision Aid
Use decision aid
Questionnaire Administration
Ancillary studies

Locations

Country Name City State
United States M D Anderson Cancer Center Houston Texas

Sponsors (2)

Lead Sponsor Collaborator
M.D. Anderson Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
See also
  Status Clinical Trial Phase
Completed NCT01204476 - Cixutumumab, Everolimus, and Octreotide Acetate in Treating Patients With Advanced Low to Intermediate Grade Neuroendocrine Carcinoma Phase 1
Completed NCT00028496 - Vaccine Therapy With or Without Sargramostim in Treating Patients With Advanced or Metastatic Cancer Phase 1
Completed NCT02592356 - Effect of Cabozantinib S-Malate or Lenvatinib Mesylate on Weight and Body Composition in Patients With Metastatic Endocrine Cancer N/A
Completed NCT01709435 - Cabozantinib S-Malate in Treating Younger Patients With Recurrent or Refractory Solid Tumors Phase 1
Active, not recruiting NCT02293954 - Copper Cu 64 Anti-CEA Monoclonal Antibody M5A PET in Diagnosing Patients With CEA Positive Cancer N/A
Active, not recruiting NCT02867592 - Cabozantinib-S-Malate in Treating Younger Patients With Recurrent, Refractory, or Newly Diagnosed Sarcomas, Wilms Tumor, or Other Rare Tumors Phase 2
Completed NCT01155258 - Temsirolimus and Vinorelbine Ditartrate in Treating Patients With Unresectable or Metastatic Solid Tumors Phase 1
Completed NCT00519896 - Sunitinib Malate in Treating Patients With Iodine-Refractory Recurrent or Metastatic Thyroid Cancer Phase 2
Recruiting NCT04759911 - Selpercatinib Before Surgery for the Treatment of RET-Altered Thyroid Cancer Phase 2
Completed NCT00134043 - Suberoylanilide Hydroxamic Acid in Treating Patients With Metastatic and/or Locally Advanced or Locally Recurrent Thyroid Cancer Phase 2
Completed NCT00118248 - Tanespimycin in Treating Patients With Inoperable Locoregionally Advanced or Metastatic Thyroid Cancer Phase 2
Completed NCT00655655 - Everolimus and Vatalanib in Treating Patients With Advanced Solid Tumors Phase 1
Completed NCT00068497 - Gefitinib in Treating Patients With Metastatic or Unresectable Head and Neck Cancer or Non-Small Cell Lung Cancer N/A
Completed NCT00004074 - Interleukin-12 and Trastuzumab in Treating Patients With Cancer That Has High Levels of HER2/Neu Phase 1

External Links