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Идёт набор NCT05250284

The Intersection of Oncology Care and Worker Well-Being

— Наблюдательное Solid Tumor

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: WellBQ, PROMIS.
Кому может быть актуально
Состояния в реестре: Solid Tumor. Базовые параметры: 21 лет — 70 лет · Мужчины.
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 →

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Обзор

The goals of this study will be a greater understanding of cancer patients' well-being experience through the care/treatment continuum. An important aspect of the study is an understanding of work- and treatment-related challenges experienced by low-income men, many of whom will be Latino. At the 12-month observation period, the investigators will learn whether these men work long-term and how work status relates to well-being.

Подробное описание

Labor supply and well-being outcomes will be evaluated at 3 timepoints (baseline, start of treatment, 12 months). The likelihood of remaining employed will be estimated with linear probability models as is the convention in labor economics. The study team also estimate employment using analogous logistic models, reporting marginal effects. Weekly hours worked will be estimated using ordinary least squares regression. In addition to measuring raw hours, the team estimate change and percent change in hours worked from baseline. These models can be expanded to accommodate control variables for worksite and job characteristics as well as accommodations, satisfaction, and other covariates predictive employment and hours worked.

Well-being will be assessed as specified by the Worker Well-Being Questionnaire (WellBQ) Manual23 and Patient Reported Outcomes Measurement Information Systems (PROMIS) domains. For PROMIS, subjects respond to a 4-item questionnaire for each domain. Responses are summed and standardized to t-scores, with higher t-scores representing higher levels of the domain measured. For example, an individual with a PROMIS depression t-score of 50 is the average observed in the general U.S. population, while a t-score of 60 indicates one standard deviation above the average score in the general population and represents moderate depressive symptoms. Guided by previous health literature, the team consider a half standard deviation (5-point) increase from initial scores a meaningful improvement for all PROMIS domains. The literature also suggests that meaningful change ranges from 2 to 6 points. Secondary to Aim 1, the team will assess the correlation between PROMIS measures and WellBQ. The WellBQ is at an earlier stage of adoption, warranting side-by-side comparison with established instruments like PROMIS. The InCharge instrument will be evaluated as suggested by the developers.

Вмешательства

  • Поведенческое WellBQ
    National Institue for Occupational Safety and Health Worker Well-Being Questionnaire is comprised of 21 scales (multiple items assessing a single construct) and 31 single items that cover worker well-being. Domains include (i) work evaluation and experience, (ii) workplace policies and culture, (iii) workplace physical environment and safety climate, (iv) health status, and (v) home, community, and society.
  • Поведенческое PROMIS
    Patient-Reported Outcomes Measurement Information System is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children.

Первичные конечные точки

  • Employment Hours Worked [Срок оценки: 2 years]
  • Worker Well-being [Срок оценки: 2 years]
  • Psychosocial Outcomes of Employed Males with Cancer using the validated Stress Thermometer. [Срок оценки: 2 years]
  • Psychosocial Outcomes of Employed Males with Cancer using PROMIS domains [Срок оценки: 2 years]
  • Financial Burden of Employed Males with Cancer [Срок оценки: 2 yearas]

Критерии участия

Критерии включения

  • Males
  • Ages 21 to 70
  • Newly diagnosed with a first primary solid tumor
  • colorectal, lung, and head and neck
  • Currently employed (defined as working 10+ hours per week) with the intention to continue working or return to work
  • Within 2 months of initiating infusion chemotherapy, oral agent, or radiation therapy

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • University of Colorado Anschutz Medical Campus — Aurora

Идентификаторы

NCT: NCT05250284 · 21-4139.cc · U19OH011227

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗