A Home-Based Prehabilitation Exercise Intervention for Improving Physical Function in Patients With Bladder Cancer and Upper Tract Urothelial Cancer, Get Moving Trial

Официальное название

The "Get Moving Trial": A Phase I/II RCT of Home-Based (P)Rehabilitation With ExerciseRx in Bladder Cancer and Upper Tract Urothelial Cancer

Обзор

Prehabilitation refers to the process of improving a patient's functional capabilities prior to a surgical procedure with the goal of decreasing post-surgical inactivity and physical decline. This clinical trial evaluates the utility of a personalized home-based prehabilitation exercise intervention for the improvement of physical function and surgical outcomes in patients with urothelial carcinoma undergoing definitive or consolidative surgery of the bladder (radical cystectomy) or upper tract (nephroureterectomy, ureterectomy) with or without preceding neoadjuvant/systemic therapy. The exercise intervention includes at-home exercise sessions focused on the improvement of core strength and balance as well as personalized step count goals, delivered to patients remotely via a smart-device-based application (ExerciseRx). Encouraging physical activity before surgery may improve physical function and surgical outcomes in patients who are scheduled to undergo surgery for their bladder or urothelial cancer.

Подробное описание

OUTLINE: Patients are randomized to 1 of 2 arms and are followed from enrollment through surgery, and for 90 days following surgery (total estimated time on study: \~4-7 months).

ARM A: Starting at least 4 weeks prior to date of surgery, patients use the ExerciseRx application (app) to follow the (P)REHAB exercise program, which consists of four 20-30 minute home exercise sessions per week approximately 4-6 weeks prior to surgery and personalized step count goal setting and tracking, while receiving standard of care (SOC) chemotherapy, if applicable, prior to SOC surgery, and for 90 days following surgery. Patients also wear a FitBit and use the FitBit app on study.

ARM B: Patients receive SOC educational materials and, starting at least 4 weeks prior to date of surgery, patients wear a FitBit and use the FitBit app while receiving SOC chemotherapy, if applicable, prior to SOC surgery.

After completion of study intervention, patients are followed up at 90 days following SOC surgery.

Вмешательства

• Другое Best Practice
  Receive SOC educational materials
• Другое Exercise Intervention
  Receive (P)REHAB exercise program
• Другое App-Based Intervention
  Use ExerciseRx app
• Другое App-Based Intervention
  Use FitBit app
• Другое Interview
  Ancillary studies
• Другое Wearable Activity Tracker
  Wear FitBit
• Другое Physical Performance Testing
  Ancillary studies
• Другое Questionnaire Administration
  Ancillary studies

Первичные конечные точки

• Trial recruitment [Срок оценки: At enrollment]
• Trial retention [Срок оценки: Through study completion, on average 4-7 months]
• Change in physical function [Срок оценки: From enrollment (T1) to 1-4 months post enrollment (before surgery) (T2)]
• Change in physical function [Срок оценки: From 1-4 months post enrollment (before surgery) (T2) to 4-7 months post enrollment (90 days post surgery) (T3)]
• Change in physical function [Срок оценки: From enrollment (T1) to 4-7 months post enrollment (90 days post surgery) (T3)]

Вторичные конечные точки (12)

• Protocol adherence [Срок оценки: Through study completion, on average 7 months]
• Patient experience with use of ExerciseRx app, including app engagement ([P]REHAB arm only) (feasibility) [Срок оценки: Through study completion, on average 7 months]
• Frailty [Срок оценки: From enrollment (T1) to 3-4 months post enrollment (before surgery) (T2)]
• Frailty [Срок оценки: From 3-4 months post enrollment (before surgery) (T2) to 4-7 months post enrollment (90 days post surgery) (T3)]
• Frailty [Срок оценки: From enrollment (T1) to 4-7 months post enrollment (90 days post surgery) (T3]
• Body composition - fat free mass [Срок оценки: From enrollment (T1) to 3-4 months post enrollment (before surgery) (T2)]
• Body composition - fat free mass [Срок оценки: From 3-4 months post enrollment (before surgery) (T2) to 4-7 months post enrollment (90 days post surgery) (T3)]
• Body composition - fat free mass [Срок оценки: From enrollment (T1) to 4-7 months post enrollment (90 days post surgery) (T3)]
• Body composition - fat mass [Срок оценки: From enrollment (T1) to 3-4 months post enrollment (before surgery) (T2)]
• Body composition - fat mass [Срок оценки: From 3-4 months post enrollment (before surgery) (T2) to 4-7 months post enrollment (90 days post surgery) (T3)]
• Body composition - fat mass [Срок оценки: From enrollment (T1) to 4-7 months post enrollment (90 days post surgery) (T3)]
• Patient-reported health-related quality of life [Срок оценки: At enrollment, 3-4 months from enrollment (before surgery), 4-7 months from enrollment (90 days post surgery)]

Критерии участия

Критерии включения

• 18 years of age or older
• English-speaking
• Planned treatment with radical cystectomy or radical nephroureterectomy/ureterectomy with or without preceding systemic therapy as indicated by the patient's surgeon with enough time to complete a minimum of 4 weeks of exercises before surgery if enrolled in the (P)REHAB arm
• Willing and able to participate in trial activities

Критерии исключения

• Cognitive/mental impairment that will preclude ability to participate in routine exercise activities. Significant cognitive or memory impairment or baseline dementia that would preclude a patient's ability to follow instructions or reproduce exercises
• Immobility, inability/unwillingness to perform personalized exercise program. Inability to perform exercises safely from seated or standing position at home or recent falls or high fall risk. Neurologic or orthopedic condition(s) that restricts participation in unsupervised home exercises, such as prior stroke with neurologic impairment, weight-bearing precautions, or unwillingness to participate in exercises
• Participants who have nonmuscle-invasive urothelial cancer of the bladder/upper tract anticipating undergoing organ-preserving treatments, or radiographic evidence of metastatic disease involving other organs including brain metastases.
• Patients with predominant histology other than urothelial carcinoma of the bladder or upper tracts (e.g. metastasis from another cancer) who would not otherwise be considered candidates for standard definitive or consolidative surgeries (radical cystectomy, ureterectomy, radical nephroureterectomy) with/without treatment with preoperative/neoadjuvant systemic therapy.
• 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
• Pregnant women are excluded from this study
• Inability to understand or read English
• Lack of access or lack of sufficient facility to use an Android or iOS smart device with the minimum criteria for using ExerciseRx
• Not receiving surgery at UWMC
• Participation in a clinical trial that does not permit enrollment in the Get Moving 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

Публикации

• Zhu A, Sher J, Li R, Ioseliani O, Cantor L, Brewer EG, Landis K, Bridges D, Munson SA, Hunter H, Lin C, Psutka SP. What motivates bladder cancer patients to be active? A qualitative study assessing attitudes towards physical activity and digital health technologies. Urol Oncol. 2025 Sep;43(9):522.e1-522.e8. doi: 10.1016/j.urolonc.2025.05.002. Epub 2025 May 28. PMID 40441948

Идентификаторы

NCT: NCT06040762 · RG1123479 · NCI-2023-05596 · RG1123479 · FHIRB0020171

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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