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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-13314 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2017-0817 | Other Identifier | M D Anderson Cancer Center |
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This study is to find out the acceptability of a 3D printed breast model by patients as they consider their surgical treatment options. Researchers also want to learn the possible impact of the 3D printed breast model in the patient's decision making process.
PRIMARY OBJECTIVE:
I. To determine feasibility and explore the acceptability of 3 dimensional (3D) printed breast models as a decision aid in breast cancer treatment decision making.
OUTLINE:
Patients complete questionnaire over 5 minutes about difficulties in making decision about breast cancer treatment, then participate in a consultation with regular care doctor and study doctor/study staff using the 3D breast model. Patients then complete questionnaires over 5-10 minutes about their opinions on the breast model and different breast surgical treatment options available.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational (questionnaire, 3D breast model, discussion) | Patients complete questionnaire over 5 minutes about difficulties in making decision about breast cancer treatment, then participate in a consultation with regular care doctor and study doctor/study staff using the 3D breast model. Patients then complete questionnaires over 5-10 minutes about their opinions on the breast model and different breast surgical treatment options available. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Decision Aid | Other | Use 3D printed breast model |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in patient decisional conflict | Will be assessed based on changes in decisional conflict scale data collected before and after use of the 3 dimensional (3D) printed breast model during consultation with the breast surgeon using paired sample t-tests. | 45 minutes - up to 12 months |
| Acceptability of the 3D model | Will be measured with questions adapted from the Ottawa measures. 'Acceptability' (of a decision aid) refers to ratings regarding the comprehensibility of components of a decision aid, its length, pace (if audio-visual), amount of information, balance in presentation of information about options, and overall suitability for decision making. Responses are reported descriptively in terms of the proportions of patients responding positively or negatively on each criterion. | 45 minutes - up to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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Women with breast cancer who are candidates for surgical management and agreed to have a 3D model created
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| Name | Affiliation | Role |
|---|---|---|
| Elsa Arribas | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MDAndersonCancerCenterWebsite | View source |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D003661 | Decision Support Techniques |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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| Discussion | Procedure | Participate in consultation |
|
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| Questionnaire Administration | Other | Complete questionnaires |
|
| D017437 |
| Skin and Connective Tissue Diseases |