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Идёт набор NCT05391217

Feasibility of Remote Activity Assessment and PRO Collection Among Transgender Cancer Survivors

— Наблюдательное Neoplasms Chronic Disease

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: Remote assessment of patient reported outcomes and daily activity.
Кому может быть актуально
Состояния в реестре: Neoplasms, Chronic Disease. Базовые параметры: от 18 лет · Все.
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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Официальное название

Study to Remotely Monitor Activity in Transgender Cancer Survivors

Обзор

Prospective observational feasibility study to evaluate the role of wearable activity monitors to determine the feasibility and acceptability of remote monitoring using wearable technology and PROs to monitor fatigue and physical function in transgender cancer patients and survivors.

Подробное описание

Transgender cancer survivors are a diverse population who currently suffer from cancer-related disparities. Enrolled subjects will receive wearable activity devices to help understand how their daily activity (e.g., daily step counts, stairs climbed) and sleep levels are affected by their symptoms and treatment side-effects, including fatigue, physical functioning, emotional well-being, sleep quality, and quality of life over the 2-week course of the study. Qualitative interviews will be conducted to gain a deeper understanding of barriers to physical activity and their perceived relationships with their cancer history, treatment symptoms and gender affirming hormone therapy.

Вмешательства

  • Другое Remote assessment of patient reported outcomes and daily activity
    Electronic patient-reported outcomes (NIH PROMIS) will be collected and combined with remotely monitored physical activity, heart rate, and sleep, as measured with a Fitbit (Sense).

Первичные конечные точки

  • Feasibility of Remote Activity Assessment and PRO Collection [Срок оценки: 2 weeks]
Вторичные конечные точки (5)
  • Key themes and concepts surrounding the relationships patients have with their treatment symptoms and how they affect their daily activity [Срок оценки: 2 weeks]
  • Average daily step count (steps/day) [Срок оценки: 2 weeks]
  • 24-Hour Movement [Срок оценки: 2 weeks]
  • Patient-reported health and well-being [Срок оценки: 2 weeks]
  • Patient-reported mood [Срок оценки: up to 2 weeks]

Критерии участия

Критерии включения

  • Self-identifies as transgender person with a history of cancer or receiving treatment for cancer in the last five years from screening for the current study (case) OR self-identifies as transgender person without a history of cancer (control)
  • 18 years or older
  • Ambulatory (use of walking aids, such as cane and rollator, is acceptable)
  • Access to a device (e.g., smartphone, tablet, iPhone) that has the capability to sync to the Fitbit
  • Have an understanding, ability, and willingness to fully comply with study procedures and restrictions
  • Can read and understand English, Spanish, or Tagalog (for participant surveys and interviews)
  • Informed consent obtained from subject and ability for subject to comply with the requirements of the study.

Критерии исключения

  • Any person that does not meet the listed criteria above
  • Using a pacemaker, implantable cardiac defibrillator, neurostimulator, implantable hearing aids, cochlear implants, or other electronic medical equipment\*. However, removable hearing aids are permitted.

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • Cedars-Sinai Medical Center — Los Angeles

Идентификаторы

NCT: NCT05391217 · STUDY00001826

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗