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

• ClinicalTrials.gov Identifier: NCT03572374
• Recruitment Status: Recruiting
• First Posted: June 28, 2018
• Last Update Posted: July 2, 2021
• Sponsor: Memorial Sloan Kettering Cancer Center
• Information provided by (Responsible Party): Memorial Sloan Kettering Cancer Center

Tracking Information

• First Submitted Date: June 8, 2018
• First Posted Date: June 28, 2018
• Last Update Posted Date: July 2, 2021
• Actual Study Start Date: June 7, 2018
• Estimated Primary Completion Date: June 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 26, 2018)

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.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Talking to Employers and Medical Staff About Breast Cancer Treatment and Your Job
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care
• Condition: Breast Cancer

Intervention

• 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)
• 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.

Study Arms

• 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.
  Intervention: Other: TEAMWork App
• 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.
  Intervention: Other: Information Booklet

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: February 12, 2020): 546
• Original Estimated Enrollment (submitted: June 26, 2018): 450
• Estimated Study Completion Date: June 2022
• Estimated Primary Completion Date: June 2022 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Breast cancer

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Victoria Blinder, M.D., M.Sc.; 646-888-4808; blinderv@mskcc.org

Contact: Francesca Gany, M.D., M.Sc.; 646-888-8054

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03572374
• Other Study ID Numbers: 18-217
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Responsible Party: Memorial Sloan Kettering Cancer Center
• Study Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: Not Provided

Investigators

• Principal Investigator: Victoria Blinder, M.D., M.Sc.; Memorial Sloan Kettering Cancer Center

• PRS Account: Memorial Sloan Kettering Cancer Center
• Verification Date: July 2021