Talking to Employers and Medical Staff About Breast Cancer Treatment and Your Job
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03572374 |
Recruitment Status :
Recruiting
First Posted : June 28, 2018
Last Update Posted : December 8, 2022
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Sponsor:
Memorial Sloan Kettering Cancer Center
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
Tracking Information | |||||||||
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First Submitted Date ICMJE | June 8, 2018 | ||||||||
First Posted Date ICMJE | June 28, 2018 | ||||||||
Last Update Posted Date | December 8, 2022 | ||||||||
Actual Study Start Date ICMJE | June 7, 2018 | ||||||||
Estimated Primary Completion Date | June 2023 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
number of participants still employed [ Time Frame: 2 years ] Talking to Employers and Medical Staff About Work (TEAMWork) the mobile application (app) is designed to educate patients and improve their communication skills with their employers and their oncology providers, thereby increasing access to work accommodations and optimizing symptom control during treatment. By increasing patients" ability to work during treatment, we believe the app will help them retain their jobs.
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Talking to Employers and Medical Staff About Breast Cancer Treatment and Your Job | ||||||||
Official Title ICMJE | Breast Cancer and the Workforce: Talking to Employers and Medical Staff About Work (TEAMWork) | ||||||||
Brief Summary | The purpose of this study is learn more about how being treated for breast cancer affects patients' employment. Researchers are testing an early version of a mobile app designed to help breast cancer patients keep their jobs during and after treatment. The app provides advice for patients to use when having conversations about breast cancer with their employers and their doctors. The app is called TEAMWork (Talking to Employers And Medical staff about Work). In this study, the investigators are asking breast cancer patients who are about to receive treatment or who are currently receiving treatment to tell us what aspects of the app work well, so that they can learn how to improve it. | ||||||||
Detailed Description | Not Provided | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Not Applicable | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Supportive Care |
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Condition ICMJE | Breast Cancer | ||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Blinder VS, Patil S, Finik J, Makower D, Muppidi M, Lichtenthal WG, Parker PA, Claros M, Suarez J, Narang B, Gany F. An interactive mobile application versus an educational booklet to promote job retention in women undergoing adjuvant chemotherapy for breast cancer: a randomized controlled trial. Trials. 2022 Oct 3;23(1):840. doi: 10.1186/s13063-022-06580-7. | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
546 | ||||||||
Original Estimated Enrollment ICMJE |
450 | ||||||||
Estimated Study Completion Date ICMJE | June 2023 | ||||||||
Estimated Primary Completion Date | June 2023 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria: Patient Usability Testing Inclusion Criteria:
Community Usability Testing Inclusion Criteria:
Focus Group and Interview Inclusion Criteria:
For Cohort 2:
RCT Inclusion Criteria:
Exclusion Criteria: RCT Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03572374 | ||||||||
Other Study ID Numbers ICMJE | 18-217 | ||||||||
Has Data Monitoring Committee | Not Provided | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||||||
Current Responsible Party | Memorial Sloan Kettering Cancer Center | ||||||||
Original Responsible Party | Same as current | ||||||||
Current Study Sponsor ICMJE | Memorial Sloan Kettering Cancer Center | ||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE |
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PRS Account | Memorial Sloan Kettering Cancer Center | ||||||||
Verification Date | December 2022 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |