Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Talking to Employers and Medical Staff About Breast Cancer Treatment and Your Job

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 : July 2, 2021
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Other: TEAMWork App Other: Information Booklet Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 546 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Breast Cancer and the Workforce: Talking to Employers and Medical Staff About Work (TEAMWork)
Actual Study Start Date : June 7, 2018
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: TEAMWork App
The 2-pronged approach of the intervention is operationalized through 2 menus, 1 focused on interactions with the employer and the other with the clinic team. Each menu has a list of features from which participants can choose to learn about a particular topic. A "My notes" button allows participants to take notes directly on the app. These notes will not be available to the research team, such that participants may use the tool without concerns about privacy. The workplace accommodations menu includes sample videos using trained actors to demonstrate how to approach an employer to request accommodations. Additional features include suggestions for accommodations that may be helpful, templates for letters participants can use when requesting accommodations, links to relevant websites, information about legal protections, and contact information for lawyers and firms that provide pro bono assistance.
 Other: TEAMWork App
The 2-pronged approach of the intervention is operationalized through 2 menus, 1 focused on interactions with the employer and the other with the clinic team. Each menu has a list of features from which participants can choose to learn about a particular topic. A "My notes" button allows participants to take notes directly on the app. These notes will not be available to the research team, such that participants may use the tool without concerns about privacy. The workplace accommodations menu includes sample videos using trained actors to demonstrate how to approach an employer to request accommodations. Additional features include suggestions for accommodations that may be helpful, templates for letters participants can use when requesting accommodations, links to relevant websites, information about legal protections, and contact information for lawyers and firms that provide pro bono assistance.
Other Name: Talking to Employers and Medical Staff About Work (TEAMWork)
Active Comparator: Information Booklet (control)
Participants will receive a booklet that includes the information in the app that can practicably be converted to paper. These participants will not have access to the multimedia aspects of the intervention, such as the videos, but they will have all of the relevant information in the app described above, including suggestions for accommodations, written templates for letters, links to websites, information about legal protections, and contact information for pro bono legal assistance. The booklet will also contain information about chemotherapy, radiation therapy and surgery, recommendations for management of common symptoms, and advice for communicating with the clinic team. The information booklet will be provided entirely on paper, although participants may independently access websites recommended in the booklet. The booklet content will mirror the app with regard to cultural responsiveness and appropriateness for different job types and characteristics.
 Other: Information Booklet
Participants in the control arm will receive a booklet that includes the information in the app that can practicably be converted to paper. These participants will not have access to the multimedia aspects of the intervention, such as the videos, but they will have all of the relevant information in the app described above, including suggestions for accommodations, written templates for letters, links to websites, information about legal protections, and contact information for pro bono legal assistance. The booklet will also contain information about chemotherapy, radiation therapy and surgery, recommendations for management of common symptoms, and advice for communicating with the clinic team. The information booklet will be provided entirely on paper, although participants may independently access websites recommended in the booklet. The booklet content will mirror the app with regard to cultural responsiveness and appropriateness for different job types and characteristics.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Breast cancer
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patient Usability Testing Inclusion Criteria:

  • History of a cancer diagnosis
  • At least 18 years of age
  • Male or Female
  • The ability to give informed consent in English or Spanish
  • Able to use and read a smartphone (iPhone or Android)
  • Has a smartphone (iPhone or Android)

Community Usability Testing Inclusion Criteria:

  • At least 18 years of age
  • Male or Female
  • The ability to give informed consent in English or Spanish
  • Able to use and read a smartphone (iPhone or Android)
  • Has a smartphone (iPhone or Android)

Focus Group and Interview Inclusion Criteria:

  • Completed chemotherapy treatment for stage I-III breast cancer.
  • Age 18 to 64 (inclusive)
  • Female
  • Paid employment (full time or part time) in the three months prior to diagnosis or at time of consent to MSK protocol #10-071 (PI: Blinder)
  • The ability to give informed consent in English or Spanish
  • Able to use and read a smartphone (iPhone or Android)
  • Has a smartphone (iPhone or Android)

For Cohort 2:

  • Participants was covered by Emergency Medicaid at the time of diagnosis and/or at any point during their treatment for breast cancer

RCT Inclusion Criteria:

  • Planning to undergo adjuvant or neoadjuvant chemotherapy for stage I-III breast cancer*
  • Age 18 to 64 (inclusive)
  • Female
  • Paid employment (full time or part time) at time of consent
  • The ability to give informed consent English or Spanish
  • Able to use and read a smartphone (iPhone or Android)
  • Has a smartphone (iPhone or Android)
  • Has low confidence in requesting workplace accommodations (based on a brief screening survey included as Appendix C). Low confidence is defined by having a score of 7 or lower on any of the five measures included in this appendix.

Exclusion Criteria:

RCT Exclusion Criteria:

  • Recurrence with metastases of breast cancer
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03572374


Contacts
Layout table for location contacts
Contact: Victoria Blinder, M.D., M.Sc. 646-888-4808 blinderv@mskcc.org
Contact: Francesca Gany, M.D., M.Sc. 646-888-8054

Locations
Layout table for location information
United States, New Jersey
Memoral Sloan Kettering Basking Ridge Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Victoria Blinder, M.D., M.Sc    646-888-4808      
Memorial Sloan Kettering Monmouth Recruiting
Middletown, New Jersey, United States, 07748
Contact: Victoria Blinder, MD, MSc    646-888-4808      
United States, New York
Lincoln Medical and Mental Health Center Recruiting
Bronx, New York, United States, 10451
Contact: Monica Muppidi, MD    718-579-5874      
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
Contact: Della Makower, MD    718-862-8840      
Memorial Sloan Kettering Commack Recruiting
Commack, New York, United States, 11725
Contact: Victoria Blinder, M.D., M.Sc.    646-888-4808      
Memorial Sloan Kettering Westchester Recruiting
Harrison, New York, United States, 10604
Contact: Victoria Blinder, M.D., M.Sc    646-888-4808      
Ralph Lauren Center for Cancer Care and Prevention Recruiting
New York, New York, United States, 10035
Contact: Victoria Blinder, M.D., M.Sc.    646-888-4808      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Victoria Blinder, M.D., M.Sc    646-888-4808      
Contact: Francesca Gany, M.D., M.Sc    646-888-8054      
Memorial Sloan Kettering Nassau Recruiting
Uniondale, New York, United States, 11553
Contact: Victoria Blinder, MD, M.Sc.    646-888-4808      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
Layout table for investigator information
Principal Investigator: Victoria Blinder, M.D., M.Sc. Memorial Sloan Kettering Cancer Center
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03572374    
Other Study ID Numbers: 18-217
First Posted: June 28, 2018    Key Record Dates
Last Update Posted: July 2, 2021
Last Verified: July 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
Workforce
Employers
Talking to Employers and Medical Staff About Work (TEAMWork)
18-217
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases