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Идёт набор NCT07302230

Home-Based Physical Activity Program With Digital App Versus Health Education Group for Improving Physical Activity Among Patients With Non-muscle Invasive Bladder Cancer, The EMPOWER Trial

Без фазы С лечением Localized Non-Muscle Invasive Bladder Urothelial Carcinoma Stage 0a Bladder Cancer AJCC v8 Stage 0is Bladder Cancer AJCC v8 Stage I Bladder Cancer AJCC v8

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: Internet-Based Intervention, Best Practice, Internet-Based Intervention, Exercise Intervention.
Кому может быть актуально
Состояния в реестре: Localized Non-Muscle Invasive Bladder Urothelial Carcinoma, Stage 0a Bladder Cancer AJCC v8, Stage 0is Bladder Cancer AJCC v8, Stage I Bladder Cancer AJCC v8. 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
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Официальное название

The EMPOWER Trial: Evaluating a Home-Based Physical Activity Program (PAP) With the ExerciseRx™ Digital Platform vs. Health Education Group (HEG) in People With Non-Muscle Invasive Bladder Cancer

Обзор

This clinical trial compares how well a home-based personalized physical activity program (PAP) that is delivered by a digital application (app) (the ExerciseRx app) works compared to health education in improving physical activity for patients with bladder cancer that has not reached the muscle wall of the bladder (non-muscle invasive). For people who are not physically active, previous studies have shown that increasing step counts can reduce incidence of death, reduce frailty, and reduce healthcare costs. The ExerciseRx app tracks adherence to home exercise, adapts step count goals based on the patient's progress, and provides encouraging feedback and motivation from the healthcare team. Additional features include activity summaries, progress towards current goal, nudges, helpful facts about the benefits of activity, and ideas for how to incorporate daily movement. A home-based PAP using the ExerciseRx app may work better in increasing physical activity among patients with non-muscle invasive bladder cancer compared to a health education only group.

Подробное описание

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I (Health Education Group, HEG): Patients receive recommendations from their physicians and an educational pamphlet describing physical activity goals in line with National Comprehensive Cancer Network (NCCN) Survivorship for Healthy Living Guidelines. They receive a FitBit® to wear continuously throughout the study, with the ExerciseRx app locked to the baseline home screen.

GROUP II (PAP INTERVENTION): Patients complete home exercise sessions given via the ExerciseRx app over 20-30 minutes 4 times per week for 12 weeks and receive personalized daily step count goals that gradually increase over the study period. Patients also receive a FitBit® to wear continuously throughout the study, are given access to features of the ExerciseRx app (step count goals, home exercise videos), and receive an educational pamphlet as in Group I.

After completion of the study intervention, patients are followed up at 4 weeks.

Вмешательства

  • Другое Internet-Based Intervention
    Given access to the ExerciseRx app
  • Другое Best Practice
    Given instruction to continue physical activity as usual
  • Другое Internet-Based Intervention
    Given access to the ExerciseRx app locked to the baseline home screen
  • Другое Exercise Intervention
    Complete home exercise sessions
  • Другое Health Telemonitoring
    Given a FitBit® to wear continuously
  • Другое Educational Intervention
    Given NCCN Survivorship for Healthy Living Guidelines pamphlet
  • Другое Questionnaire Administration
    Ancillary studies
  • Другое Interview
    Ancillary studies
  • Другое Electronic Health Record Review
    Ancillary studies

Первичные конечные точки

  • Change in mean daily step count [Срок оценки: Baseline (1 week prior to trial initiation) and timepoint 2 (12 weeks)]
  • Qualitative experience [Срок оценки: Week 16]
Вторичные конечные точки (12)
  • Active time/24 hours (minutes) per week on study [Срок оценки: Up to 12 weeks]
  • Change in mean daily step count [Срок оценки: Baseline up to 4 weeks post intervention]
  • Change in functional mobility [Срок оценки: Baseline up to 4 weeks post intervention]
  • Change in frailty [Срок оценки: Baseline up to 4 weeks post intervention]
  • Change in health-related quality of life [Срок оценки: Baseline up to 4 weeks post intervention]
  • Change in fatigue [Срок оценки: Baseline up to 4 weeks post intervention]
  • Change in pain [Срок оценки: Baseline up to 4 weeks post intervention]
  • Change in anxiety/depression [Срок оценки: Baseline up to 4 weeks post intervention]
  • Change in distress [Срок оценки: Baseline up to 4 weeks post intervention]
  • Change in resiliency [Срок оценки: Baseline up to 4 weeks post intervention]
  • Change in treatment burden [Срок оценки: Baseline up to 4 weeks post intervention]
  • Incidence of patient-reported musculoskeletal adverse events [Срок оценки: Baseline up to 4 weeks post intervention]

Критерии участия

Критерии включения

  • Adults (age >= 18 years)
  • Prior diagnosis of non-muscle invasive bladder cancer (NMIBC), currently on surveillance or receiving maintenance intravesical therapy (including intravesical chemotherapy, immunotherapy)
  • Classified as insufficiently active on the Physical Activity as a Vital Sign (PAVS) assessment
  • Has an Android or Apple Smartphone/Tablet
  • Ambulatory
  • English-speaking
  • Willing and able to participate in study activities and sign the informed consent form

Критерии исключения

  • Severe cognitive or memory impairment/dementia precluding ability to follow instructions or participate in survey assessments
  • Inability to read or understand English
  • Lack of access or lack of sufficient facility to use an Android or iOS smart device with the minimum criteria to run the ExerciseRx app
  • Not receiving treatment at University of Washington (UW)
  • Orthopedic, neurologic, or other problems that prevent safe ambulation and protocol adherence. Information on prior falls and other recent orthopedic or neurologic problems will be used to make judgment about protocol eligibility
  • Inability/Unwillingness to participate in a personalized exercise program
  • Current diagnosis with muscle-invasive or metastatic bladder cancer
  • Uncontrolled or concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Lack of access or lack of sufficient facility to use an Android or iOS smart device with the minimum criteria for using the ExerciseRx app
  • Participation in a clinical trial that does not permit enrollment in the EMPOWER trial

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
Простое слепое
Основная цель
Поддерживающая терапия

Центры проведения

США · 1 центр
  • Fred Hutch/University of Washington Cancer Consortium — Seattle

Идентификаторы

NCT: NCT07302230 · RG1125987 · NCI-2025-08850 · 21052

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗