Clinical trial NCT03572374: 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
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: Workforce
Employers
Talking to Employers and Medical Staff About Work (TEAMWork)
18-217
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2018-06-28
Enrollment: 546
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: number of participants still employed
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge (Consent and Follow-up)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (Consent and Follow-up)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (Consent and Follow up)
state: New Jersey
city: Bronx
country: United States
facility: Lincoln Medical and Mental Health Center
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (Consent and Follow-up)
state: New York
city: Jamaica
country: United States
facility: Queens Cancer Center of Queens Hospital
state: New York
city: New York
country: United States
facility: Bellevue Hospital Center (Data Collection Only)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Victoria Blinder, M.D., M.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
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.