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NCT04496739 · ClinicalTrials.gov registry record · NA
Making Informed Choices on Incorporating Chemoprevention Into Care (MiCHOICE)
A NA study of Lobular Breast Carcinoma in Situ and Atypical Hyperplasia of the Breast, sponsored by SWOG Cancer Research Network.
- Active
- Registry status
- NA
- Development phase
- 412
- Enrollment target
- 20
- Study locations
NCT04496739: Active NA study of Lobular Breast Carcinoma in Situ and Atypical Hyperplasia of the Breast, sponsored by SWOG Cancer Research Network.
NCT04496739 is a NA study of Lobular Breast Carcinoma in Situ and Atypical Hyperplasia of the Breast that is active but no longer recruiting, run by SWOG Cancer Research Network. The registered enrollment target is 412 participants, above the 79-participant average among 5 other Lobular Breast Carcinoma in Situ trials with a reported enrollment target (422% higher). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04496739, a NA study of Lobular Breast Carcinoma in Situ and Atypical Hyperplasia of the Breast, is active but no longer recruiting, sponsored by SWOG Cancer Research Network.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 412 participants
- Enrollment target
- 20
- Study locations
Study Summary
This trial studies the implementation of web-based decision support tools for patients with atypical hyperplasia or lobular carcinoma in situ and healthcare providers. Decision support tools are designed to improve informed choice about breast cancer chemoprevention. Recognizing barriers and facilitators that can influence the adoption of decision support tools at recruitment centers may help researchers learn how to best implement them into clinical practice.
Primary Outcome
Will be provided by chemoprevention knowledge scale, a 1-item attitudes scale, and chemoprevention decision and measure at 6 and 12 months on the S1904 Follow-Up Choice form. All enrolled patients who provide outcomes data at the 6-month timepoint will be included in the primary analysis under the intention-to-treat principle. The primary analysis of the intervention effect on informed choice at 6 months will be based on a logistic regression model using a generalized estimating equation approac
Conditions Studied
Interventions
- OTHER Questionnaire Administration
- OTHER Interview
- OTHER Decision Aid
- BEHAVIORAL Cancer Educational Materials
Study Locations (20)
California
- Kaiser Permanente-Deer Valley Medical Center - Antioch
- UC Irvine Health Cancer Center-Newport - Costa Mesa
- City of Hope Comprehensive Cancer Center - Duarte
- Kaiser Permanente-Oakland - Oakland
- UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange
- Kaiser Permanente Downtown Commons - Sacramento
- Kaiser Permanente-South Sacramento - Sacramento
- Kaiser San Rafael-Gallinas - San Rafael
- Kaiser Permanente Medical Center - Santa Clara - Santa Clara
- City of Hope South Pasadena - South Pasadena
- Kaiser Permanente-South San Francisco - South San Francisco
- Kaiser Permanente-Vallejo - Vallejo
- Kaiser Permanente-Walnut Creek - Walnut Creek
Florida
- Mount Sinai Comprehensive Cancer Center at Aventura - Aventura
- Miami Cancer Institute - Miami
- Mount Sinai Medical Center - Miami Beach
- Miami Cancer Institute at Plantation - Plantation
Georgia
- Grady Health System - Atlanta
- Emory University Hospital Midtown - Atlanta
- Emory University Hospital/Winship Cancer Institute - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 412 participants |
| Start Date | 2020-10-23 |
| Est. Completion | 2028-06-01 |
| Phase | NA |
What the registry record for NCT04496739 still lists
NCT04496739 is an interventional study that assigns participants to a tested intervention. The registered 412 participants enrollment target is mid-sized for trials with a published cap, above the 79-participant average among 5 other Lobular Breast Carcinoma in Situ trials with a reported enrollment target (422% higher).
The record links to 3 conditions, with Lobular Breast Carcinoma in Situ appearing as the primary indexed condition, and to 4 interventions - of which Questionnaire Administration is the first listed.
NCT04496739 names 20 study sites across 3 states, led by California, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT04496739 about?
NCT04496739 is a clinical study titled "Making Informed Choices on Incorporating Chemoprevention Into Care (MiCHOICE)". This trial studies the implementation of web-based decision support tools for patients with atypical hyperplasia or lobular carcinoma in situ and healthcare providers. Decision support tools are designed to improve informed choice about breast cancer chemoprevention. Recognizing barriers and facilit...
What is the current status of trial NCT04496739?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 412 participants. The study started on 2020-10-23. Estimated completion is 2028-06-01.
What conditions does trial NCT04496739 study?
This clinical trial studies the following conditions: Lobular Breast Carcinoma in Situ, Atypical Hyperplasia of the Breast, Pleomorphic Lobular Breast Carcinoma In Situ.
What interventions are being tested in trial NCT04496739?
The interventions under investigation include: Questionnaire Administration (OTHER), Interview (OTHER), Decision Aid (OTHER), Cancer Educational Materials (BEHAVIORAL).
Who is sponsoring clinical trial NCT04496739?
This trial is sponsored by SWOG Cancer Research Network, which has 270 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04496739 being conducted?
This trial has 20 study locations across California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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