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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2019-00631 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2018-0557 | Other Identifier | M D Anderson Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive care (decision aid) | Experimental | Participants use decision aid and complete questionnaires. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Decision Aid | Other | Use decision aid |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
--Individuals with cognitive or psychological impairment (e.g., depression, anxiety, severe mental illness; as documented in the registry)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth G Grubbs, MD | Contact | (713) 792-0665 | eggrubbs@mdanderson.org |
| Name | Affiliation | Role |
|---|---|---|
| Elizabeth G Grubbs, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center | View source |
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| Questionnaire Administration |
| Other |
Ancillary studies |
|
| ID | Term |
|---|---|
| D018276 | Carcinoma, Medullary |
| ID | Term |
|---|---|
| D018278 | Carcinoma, Neuroendocrine |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| D003661 | Decision Support Techniques |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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