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

NCT ID: NCT03572374

Last Updated: 2025-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

546 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-07

Study Completion Date

2026-06-30

Brief Summary

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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

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

TEAMWork App

Intervention Type OTHER

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.

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.

Group Type ACTIVE_COMPARATOR

Information Booklet

Intervention Type OTHER

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.

Interventions

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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 Type 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.

Intervention Type OTHER

Other Intervention Names

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Talking to Employers and Medical Staff About Work (TEAMWork)

Eligibility Criteria

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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)


* 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)


* 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


* Localized invasive breast cancer (not stage 0 or stage IV) per EMR or breast cancer (not stage 0 or stage IV) per self-report for community participants

* If electronic medical record does not specify stage and patient is undergoing (neo)adjuvant chemotherapy, assume stage is I, II or III
* Planning to undergo or undergoing adjuvant or neoadjuvant chemotherapy per EMR or planning to undergo or undergo chemotherapy per self-report for community participants
* Age 18 to 64 (inclusive)
* Female
* Employment statue of (full time or part time) (those who are on disability leave/medical leave, and other unique employment circumstances at the PI's dicretion are eligible)
* Language preference as English or Spanish
* Able to use and read a smartphone or tablet (e.g. iPad, iPhone or Android)
* Has access to a smartphone or tablet (e.g. iPad, iPhone or Android)

Exclusion Criteria

* Stage 0 breast cancer (DCIS only)
* Stage IV (metastatic) breast cancer
* Recurrence with metastases of breast cancer
* Participants or family members who are participating in MSK IHCD studies related to social determinants of health
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Victoria Blinder, M.D., M.Sc.

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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Memorial Sloan Kettering Basking Ridge (Consent and Follow-up)

Basking Ridge, New Jersey, United States

Site Status RECRUITING

Memorial Sloan Kettering Monmouth (Consent and Follow-up)

Middletown, New Jersey, United States

Site Status RECRUITING

Memorial Sloan Kettering Bergen (Consent and Follow up)

Montvale, New Jersey, United States

Site Status RECRUITING

Memorial Sloan Kettering Westchester (Consent and Follow-up)

Harrison, New York, United States

Site Status RECRUITING

Queens Cancer Center of Queens Hospital

Jamaica, New York, United States

Site Status RECRUITING

Bellevue Hospital Center (Data Collection Only)

New York, New York, United States

Site Status NOT_YET_RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status RECRUITING

Lincoln Medical and Mental Health Center

The Bronx, New York, United States

Site Status ACTIVE_NOT_RECRUITING

Montefiore Medical Center

The Bronx, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Victoria Blinder, M.D., M.Sc.

Role: CONTACT

646-888-4808

Francesca Gany, M.D., M.Sc.

Role: CONTACT

646-888-8054

Facility Contacts

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Victoria Blinder, M.D., M.Sc

Role: primary

646-888-4808

Victoria Blinder, MD, MSc

Role: primary

646-888-4808

Victoria Blinder, M.D., M.Sc.

Role: primary

646-888-4808

Victoria Blinder, M.D., M.Sc

Role: primary

646-888-4808

Margaret Kemeny, MD

Role: primary

718-883-4031

Tresara Bell, MD

Role: primary

844-692-4692

Victoria Blinder, M.D., M.Sc

Role: primary

646-888-4808

Francesca Gany, M.D., M.Sc

Role: backup

646-888-8054

Della Makower, MD

Role: primary

718-862-8840

References

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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.

Reference Type DERIVED
PMID: 36192754 (View on PubMed)

Related Links

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http://www.mskcc.org/mskcc/html/44.cfm

Memorial Sloan Kettering Cancer Center

Other Identifiers

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18-217

Identifier Type: -

Identifier Source: org_study_id

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