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Идёт набор NCT06505590

STEpwise Research Program to Promote INGeniouS ONline Supportive Solutions in the Relief of Cancer-related Fatigue

Без фазы С лечением Cancer Diagnosis Moderate or Severe Score of Cancer-related Fatigue (CRF)

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: Educational content, Educational material plus self-management program - self-administered version, Educational material plus self-management program - guided version with mental health professional.
Кому может быть актуально
Состояния в реестре: Cancer Diagnosis, Moderate or Severe Score of Cancer-related Fatigue (CRF). 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
Франция
Следующий шаг
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Официальное название

STEpwise Research Program to Promote INGeniouS ONline Supportive Solutions in the Relief of Cancer-related Fatigue (STEPPING-STONe)

Обзор

Decentralized, randomized hybrid type 2 (effectiveness/implementation) controlled trial comparing the effectiveness of three different digital aid modalities programs in reducing the perceived burden of CRF in cancer patients while also gathering data on the implementation strategy.

Вмешательства

  • Устройство Educational content
    Patients will have access to educational content on the mobile app Resilience © in the format of articles, videos or podcasts on treatment related symptoms and on validated supportive care interventions. This version is currently public available in France and Belgium at www.resilience.care and is considered the control group (education only).
  • Устройство Educational material plus self-management program - self-administered version
    Patients will have access to the same mobile app (Resilience ©) with its educational content will be powered with a self-guided fatigue self-management program based on a cognitive behavioral therapy approach.
  • Устройство Educational material plus self-management program - guided version with mental health professional
    Patients will have access to the same mobile app (Resilience ©) with its educational content and the self-management program of arm 2 and weekly calls with a certified mental health professional certified in cognitive behavioural therapy for guided coaching across the self-management program.

Первичные конечные точки

  • Compare the effectiveness of standard of care plus three different types of digital aid modalities for the patient. [Срок оценки: 3 months and 6 months after the end of the program.]

Критерии участия

Критерии включения

  • Age 18 years and older.
  • Having a clinical diagnosis of cancer including patients on active treatment or cancer survivors.
  • Self-reporting moderate to severe CRF for at least one week (worst level of fatigue ≥ 4 on a 10-point numerical rating scale, retained in international guidelines as an optimal cutoff for identifying clinically significant CRF).
  • Being able to read and understand French.
  • Having access to a smartphone.
  • Patients must be affiliated to a social security system or beneficiary of the same.

Критерии исключения

  • Suffering from current psychiatric disorder or cognitive disorder that would interfere with the ability to consent or participate.
  • Currently engaging in cognitive-behavioral therapy.
  • Currently engaging in another non-drug (behavioral) clinical trial.
  • Suffering from physical related reversible and treatable causes of fatigue (anemia, electrolytes unbalance, infections, renal dysfunction, active metastases causing fatigue, hormonal unbalances (hypothyroidism, adrenal insufficiency, etc.) - according to physician's judgement at the moment of inclusion.

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

Франция · 1 центр
  • Gustave Roussy — Villejuif

Публикации

  • Franzoi MA, Pages A, Charles C, Debiasi M, Gillanders E, Ferreira A, Jacques F, Everhard S, GaryBobo G, Sambou C, Alla F, Quivy A, Morin S, Vaz-Luis I. The effectiveness and implementation of a STEpwise Program to Promote INGeniouS ONline supportive solutions for self-management of cancer-related fatigue: The STEPPING-STONe digitally enabled randomized trial. Contemp Clin Trials. 2025 Aug;155:1079 PMID 40581251

Идентификаторы

NCT: NCT06505590 · 2023-A02082-43 · 2023/3717

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗