Employment Support After Hematopoietic Stem Cell Transplantation

Официальное название

Supportive Care Intervention Development to Address Employment Concerns After Allogeneic Hematopoietic Stem Cell Transplantation

Обзор

This is a feasibility study of a Work Support (WorkS) intervention designed to ameliorate employment challenges for people preparing to return to work after allogeneic stem cell transplantation. The aim of this study is to evaluate "proof of concept" by: 1. examining the feasibility and acceptability of the WorkS intervention and the study procedures, and 2. exploring the preliminary effects of WorkS for improving patient-reported return-to-work self-efficacy, work status, quality of life, and financial toxicity.

Подробное описание

Participants will be recruited from MGH Cancer Center. The intervention will be delivered at MGH Institute of Health Professions (IHP) and investigators at MGH IHP will be involved in recruiting participants and collecting/managing data.

Participants will be enrolled in the study for approximately six months following the schedule below:

* Enrollment into study: HSCT recipients will be recruited into the study approximately six months post HSCT (+/- one month). * Baseline assessment: To be completed within 3 weeks of completing informed consent. * WorkS Appointment #1 and #2: To be completed within a 2-month period after completing the baseline assessment. Ideally, the appointments will be approximately one month apart, but can be timed whenever in the 2-month window that is preferred by the participant. * Exit assessment: To be completed within 3 weeks of completing Appointment 2. * Final assessment: Return to work status at 12 months post HSCT (+/- three weeks)

Вмешательства

• Поведенческое Work Support (WorkS)
  The WorkS intervention entails two structured visits with a research team member initiated 6-months post-HSCT, which is the earliest point at which most HSCT survivors can safely consider returning to work. The sessions are focused on 1) identifying challenges of navigating work and illness; 2) linking survivors with psychological, rehabilitative, governmental, and community resources that can promote recovery and well-being; and 3) communicating with employers regarding the necessary work modif

Первичные конечные точки

• Screening Rate [Срок оценки: At screening]
• Eligibility Rate [Срок оценки: At screening]
• Enrollment Rate [Срок оценки: Up to 2 months]
• Intervention completion Rate [Срок оценки: Up to 2 months]
• Assessment Completion Rate [Срок оценки: Up to 6 months]

Вторичные конечные точки (6)

• Working Status [Срок оценки: 6 months]
• Financial Toxicity [Срок оценки: 2 months]
• Quality of Life: Functional Assessment of Cancer Therapy - Bone Marrow Transplant [Срок оценки: 2 months]
• Return to Work Self-Efficacy [Срок оценки: 2 months]
• Concerns Regarding Work [Срок оценки: 2 months]
• Utility of Intervention [Срок оценки: 2 months]

Критерии участия

Критерии включения

• Received an allogeneic HSCT within the past six months to treat a hematological malignancy.
• Screen positive for work-related concerns (i.e., responds "yes" to the question, "Are you concerned about your ability to return to work in the coming six months?")

Критерии исключения

• Patients with acute psychiatric or cognitive conditions which the treating clinician believes prohibits informed consent or compliance with the study procedures
• We will not enroll the following special populations: adults unable to consent, individuals not yet adults, pregnant women, and prisoners.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• MGH Cancer Center — Boston

Идентификаторы

NCT: NCT06494423 · 2024P000290

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗