NCT03572374

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
546

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
1mo left

Started Jun 2018

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

9 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Jun 2018Jun 2026

Study Start

First participant enrolled

June 7, 2018

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 8, 2018

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 28, 2018

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

March 24, 2026

Status Verified

March 1, 2026

Enrollment Period

8 years

First QC Date

June 8, 2018

Last Update Submit

March 20, 2026

Conditions

Keywords

WorkforceEmployersTalking to Employers and Medical Staff About Work (TEAMWork)18-217

Outcome Measures

Primary Outcomes (1)

  • number of participants still employed

    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.

    2 years

Study Arms (2)

TEAMWork App

EXPERIMENTAL

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

Information Booklet (control)

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: Talking to Employers and Medical Staff About Work (TEAMWork)
TEAMWork App

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.

Information Booklet (control)

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsBreast cancer
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • +14 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

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

Basking Ridge, New Jersey, 07920, United States

RECRUITING

Memorial Sloan Kettering Monmouth (Consent and Follow-up)

Middletown, New Jersey, 07748, United States

RECRUITING

Memorial Sloan Kettering Bergen (Consent and Follow up)

Montvale, New Jersey, 07645, United States

RECRUITING

Memorial Sloan Kettering Westchester (Consent and Follow-up)

Harrison, New York, 10604, United States

RECRUITING

Queens Cancer Center of Queens Hospital

Jamaica, New York, 11432, United States

RECRUITING

Bellevue Hospital Center (Data Collection Only)

New York, New York, 10016, United States

NOT YET RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Lincoln Medical and Mental Health Center

The Bronx, New York, 10451, United States

ACTIVE NOT RECRUITING

Montefiore Medical Center

The Bronx, New York, 10467, United States

RECRUITING

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Victoria Blinder, M.D., M.Sc.

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

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

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2018

First Posted

June 28, 2018

Study Start

June 7, 2018

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

March 24, 2026

Record last verified: 2026-03

Locations