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Идёт набор NCT03572374

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

Без фазы С лечением Breast Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: TEAMWork App, Information Booklet.
Кому может быть актуально
Состояния в реестре: Breast Cancer. Базовые параметры: 18 лет — 64 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Breast Cancer and the Workforce: Talking to Employers and Medical Staff About Work (TEAMWork)

Обзор

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.

Вмешательства

  • Другое 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 i
  • Другое 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 as

Первичные конечные точки

  • number of participants still employed [Срок оценки: 2 years]

Критерии участия

Критерии включения

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)

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

США · 9 центров
  • Memorial Sloan Kettering Basking Ridge (Consent and Follow-up) — Basking Ridge
  • Memorial Sloan Kettering Monmouth (Consent and Follow-up) — Middletown
  • Memorial Sloan Kettering Bergen (Consent and Follow up) — Montvale
  • Memorial Sloan Kettering Westchester (Consent and Follow-up) — Harrison
  • Queens Cancer Center of Queens Hospital — Jamaica
  • Bellevue Hospital Center (Data Collection Only) — New York
  • Memorial Sloan Kettering Cancer Center — New York
  • Lincoln Medical and Mental Health Center — The Bronx
  • … и ещё 1 центр

Публикации

  • 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. PMID 36192754

Идентификаторы

NCT: NCT03572374 · 18-217

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗