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

Primary Purpose

Breast Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TEAMWork App
Information Booklet
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Workforce, Employers, Talking to Employers and Medical Staff About Work (TEAMWork), 18-217

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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:

  • Localized invasive breast cancer (not stage 0 or stage IV)

    • 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
  • 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:

RCT 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

Sites / Locations

  • Memorial Sloan Kettering Basking Ridge (Consent and Follow-up)Recruiting
  • Memorial Sloan Kettering Monmouth (Consent and Follow-up)Recruiting
  • Memorial Sloan Kettering Bergen (Consent and Follow up)Recruiting
  • Lincoln Medical and Mental Health CenterRecruiting
  • Montefiore Medical CenterRecruiting
  • Memorial Sloan Kettering Westchester (Consent and Follow-up)Recruiting
  • Queens Cancer Center of Queens Hospital
  • Bellevue Hospital Center (Data Collection Only)
  • Memorial Sloan Kettering Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TEAMWork App

Information Booklet (control)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 8, 2018
Last Updated
October 17, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT03572374
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 7, 2018 (Actual)
Primary Completion Date
June 2026 (Anticipated)
Study Completion Date
June 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Workforce, Employers, Talking to Employers and Medical Staff About Work (TEAMWork), 18-217

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
546 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TEAMWork App
Arm Type
Experimental
Arm Description
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.
Arm Title
Information Booklet (control)
Arm Type
Active Comparator
Arm Description
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 Type
Other
Intervention Name(s)
TEAMWork App
Other Intervention Name(s)
Talking to Employers and Medical Staff About Work (TEAMWork)
Intervention Description
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
Intervention Name(s)
Information Booklet
Intervention Description
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.
Primary Outcome Measure Information:
Title
number of participants still employed
Description
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.
Time Frame
2 years

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Breast cancer
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: 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: RCT 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Victoria Blinder, M.D., M.Sc.
Phone
646-888-4808
Email
blinderv@mskcc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Francesca Gany, M.D., M.Sc.
Phone
646-888-8054
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victoria Blinder, M.D., M.Sc.
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Basking Ridge (Consent and Follow-up)
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victoria Blinder, M.D., M.Sc
Phone
646-888-4808
Facility Name
Memorial Sloan Kettering Monmouth (Consent and Follow-up)
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victoria Blinder, MD, MSc
Phone
646-888-4808
Facility Name
Memorial Sloan Kettering Bergen (Consent and Follow up)
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victoria Blinder, M.D., M.Sc.
Phone
646-888-4808
Facility Name
Lincoln Medical and Mental Health Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10451
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monica Muppidi, MD
Phone
718-579-5874
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Della Makower, MD
Phone
718-862-8840
Facility Name
Memorial Sloan Kettering Westchester (Consent and Follow-up)
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victoria Blinder, M.D., M.Sc
Phone
646-888-4808
Facility Name
Queens Cancer Center of Queens Hospital
City
Jamaica
State/Province
New York
ZIP/Postal Code
11432
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margaret Kemeny, MD
Phone
718-883-4031
Facility Name
Bellevue Hospital Center (Data Collection Only)
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tresara Bell, MD
Phone
844-692-4692
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victoria Blinder, M.D., M.Sc
Phone
646-888-4808
First Name & Middle Initial & Last Name & Degree
Francesca Gany, M.D., M.Sc
Phone
646-888-8054

12. IPD Sharing Statement

Citations:
PubMed Identifier
36192754
Citation
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.
Results Reference
derived
Links:
URL
http://www.mskcc.org/mskcc/html/44.cfm
Description
Memorial Sloan Kettering Cancer Center

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