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Идёт набор NCT06719206

Reduce Sedentary Behavior During Cancer Treatment - the RedSedCan Study

Без фазы С лечением Breast Cancer Colorectal Cancer (CRC) Prostate Cancer Neoadjuvant Therapy

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: Digital self-management program.
Кому может быть актуально
Состояния в реестре: Breast Cancer, Colorectal Cancer (CRC), Prostate Cancer, Neoadjuvant Therapy. 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
Швеция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

Summary Reducing sedentary behavior during treatment is important to reduce the risk of future health problems in individuals undergoing cancer treatment. Therefore, the goal of this project is with a multicenter randomised controlled design investigate whether a digital support intervention during ongoing neo- or adjuvant cancer treatment for breast, prostate or colon cancer is effective in reducing sedentary lifestyle and improving well-being in the short and long term.

Подробное описание

Description of the project

This project is about investigating the effect of a digital support intervention to reduce sedentary behavior in people with breast, prostate, or colorectal cancer during neo- or adjuvant cancer treatment. The digital support intervention has been developed with patients and researchers and consists of existing high-quality technology that provides support for setting and following goals. The people who use the digital support intervention also receive support from a physiotherapist to set goals for reduced sedentary time and get to choose which activities will replace the time spent sedentary.

The goal of the project

The goal of the project is to investigate the effects of a digital support intervention on reduced sedentary and well-being during ongoing cancer treatment, both in the short and long term. In addition, the project will study the health-economic effects, and climate benefits of using the digital support intervention. By focusing on reducing a sedentary lifestyle and replacing it with daily activities and/or physical activity, the health of individuals is expected to be positively affected in the short term through, for example, increased well-being and reduced side effects from cancer treatment, and the long term through a reduced risk of developing complications and new illness related to the cancer treatment, such as cardiovascular disease.

Вмешательства

  • Поведенческое Digital self-management program
    The program consists of commercially available technologies, e.g. applications including behavour change techniques for reducing sedentary behavior (SB) (i.e. self-monitorization of physical activity, reminders for breaking SB/doing physical activity, and providing feedback on physical activity/breaks from SB) and a webpage containing information and tips (provided in short videos and text) regarding how to reduce SB. The participants will be receive help with setting goals for reducing time spe

Первичные конечные точки

  • Sedentary behavior time [Срок оценки: At baseline, 3-months, 6 months, 12 months and 24 months. Axivity is worn for 7 consecutive days at each measurement point.]
Вторичные конечные точки (10)
  • Sedentary behavior bouts [Срок оценки: At baseline, 3-months, 6 months, 12 months and 24 months. Axivity is worn for 7 consecutive days at each measurement point.]
  • Physical activity [Срок оценки: At baseline, 3-months, 6 months, 12 months and 24 months. Axivity is worn for 7 consecutive days at each measurement point.]
  • Health-related quality of life [Срок оценки: At baseline, 3-months, 6 months, 12 months and 24 months.]
  • Health-related quality of life [Срок оценки: At baseline, 3-months, 6 months, 12 months and 24 months.]
  • Cancer related fatigue [Срок оценки: At baseline, 3-months, 6 months, 12 months and 24 months.]
  • Fear of movement [Срок оценки: At baseline, 3-months, 6 months, 12 months and 24 months.]
  • Changes in health [Срок оценки: At 3-months, 6 months, 12 months and 24 months.]
  • Work ability [Срок оценки: At baseline, 3-months, 6 months, 12 months and 24 months.]
  • Self-efficacy for reducing sedentary behavior [Срок оценки: At baseline, 3-months, 6 months, 12 months and 24 months.]
  • Perceived support from peers [Срок оценки: At baseline, 3-months, 6 months, 12 months and 24 months.]

Критерии участия

Критерии включения

  • Individuals diagnosed with breast, prostate, or colorectal cancer planned for or resently started neo- or adjuvant treatment (e.g. chemotherapy, radiotherapy, endocrine treatment) at the hospitals in Uppsala and Västerås, Sweden.

Критерии исключения

  • Individuals diagnosed with dementia.
  • Individuals diagnosed with severe psychiatric disease.
  • Individuals with severe loss of vision, or communicative ability.
  • Individuals who cannot walk independently indoors with or without a walking aid.
  • Individuals completed treatment for other cancer diseases less than 12 months ago or not recovered from previous cancer treatment.

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

Швеция · 2 центра
  • Akademiska sjukhuset — Uppsala
  • Västmanlands sjukhus — Västerås

Идентификаторы

NCT: NCT06719206 · 2020/1120

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗