Ignite Creation Date:
2024-05-06 @ 9:46 AM
Last Modification Date:
2024-10-26 @ 12:19 PM
Study NCT ID:
NCT03061175
Status:
COMPLETED
Last Update Posted:
2021-04-20
First Post:
2017-02-13
Brief Title:
Web-Based Decision Aid in Improving Informed Decisions in Patients With Stage 0-IIIA Breast Cancer Considering Contralateral Prophylactic Mastectomy
Sponsor:
Rutgers The State University of New Jersey
Organization:
Rutgers The State University of New Jersey
Study Overview
Official Title:
Facilitating Informed Decisions for Contralateral Prophylactic Mastectomy
Status:
COMPLETED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This pilot randomized clinical trial studies how well a web-based decision aid works in improving informed decisions in patients with stage 0-IIIA breast cancer considering contralateral prophylactic mastectomy CPM A web-based decision aid DA may help doctors determine how patients make decisions about whether or not to have contralateral prophylactic mastectomy
Detailed Description:
PRIMARY OBJECTIVES
I To develop a feasible web-based decision aid DA
SECONDARY OBJECTIVES
I To provide preliminary data on the impact of the contralateral prophylactic mastectomy CPM-DA on preparedness to make the CPM decision decisional conflict CPM knowledge psychosocial factors perceived risk for cancer in the healthybreastmetastatic disease cancer recurrencemetastasis worry cancer distress and intention to have CPM
OUTLINE
PHASE I PROTOTYPE DEVELOPMENT AND TESTING Patients attend an interview and are asked questions about experiences with CPM reasons they chose and did not choose CPM and CPM satisfaction for 60 minutes Patients then receive access to web-based CPM-DA and attend an interview over 90 minutes to provide feedback on module and to complete a prototype evaluation
PHASE II CPM-DA FEASIBILITY TRIAL Patients are randomized to 1 of 2 arms
ARM I Patients undergo usual care UC available to patients considering CPM and receive information from a medical oncologist about CPM
ARM II Patients receive a website address a secure username and password and instructions for using the web-based CPM-DA
After completion of study treatment patients are followed up at 2-4 weeks and 6 months
I To develop a feasible web-based decision aid DA
SECONDARY OBJECTIVES
I To provide preliminary data on the impact of the contralateral prophylactic mastectomy CPM-DA on preparedness to make the CPM decision decisional conflict CPM knowledge psychosocial factors perceived risk for cancer in the healthybreastmetastatic disease cancer recurrencemetastasis worry cancer distress and intention to have CPM
OUTLINE
PHASE I PROTOTYPE DEVELOPMENT AND TESTING Patients attend an interview and are asked questions about experiences with CPM reasons they chose and did not choose CPM and CPM satisfaction for 60 minutes Patients then receive access to web-based CPM-DA and attend an interview over 90 minutes to provide feedback on module and to complete a prototype evaluation
PHASE II CPM-DA FEASIBILITY TRIAL Patients are randomized to 1 of 2 arms
ARM I Patients undergo usual care UC available to patients considering CPM and receive information from a medical oncologist about CPM
ARM II Patients receive a website address a secure username and password and instructions for using the web-based CPM-DA
After completion of study treatment patients are followed up at 2-4 weeks and 6 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2017-00173 | REGISTRY | None | None |
| Pro20150001914 | None | None | None |
| 131504 | OTHER | None | None |
| P30CA072720 | NIH | None | None |
| R21CA187643 | NIH | Rutgers Cancer Institute of New Jersey | httpsreporternihgovquickSearchR21CA187643 |