A Randomized Trial of a Mobile Health Exercise Intervention for Older Adults With Myeloid Neoplasms

Официальное название

A Pilot Randomized Trial of a Mobile Health Exercise Intervention for Older Patients With Myeloid Neoplasms

Обзор

This is a phase 2 randomized controlled trial (RCT) to assess the preliminary efficacy of the a mobile health exercise intervention (GO-EXCAP) versus a chemotherapy education control in 100 older patients with MN receiving outpatient chemotherapy on physical function and patient-reported outcomes (fatigue, mood, and quality of life). We will also explore the effect of the intervention on TNFα and related cytokine gene promoter methylation and their gene and protein expression.

Подробное описание

Up to 98% of older patients with myeloid neoplasms experience physical function decline, fatigue, and mood disturbances. Mobile health exercise interventions are promising strategy to prevent physical function decline and improve fatigue and mood disturbances, but older patients with myeloid neoplasms receiving outpatient chemotherapy are understudied. The proposed study will investigate whether a novel mobile health exercise intervention that is adapted to this population can prevent physical function decline, improve fatigue and mood disturbances, and prevent worsening quality of life.

Вмешательства

• Поведенческое GO-EXCAP Mobile App
  A mobile app delivery platform to deliver an exercise program \[Exercise for Cancer Patients (EXCAP©®)\]. EXCAP©®) is a progressive walking and resistance exercise program
• Поведенческое Behavioral Placebo Control
  Participants will meet with an oncology nurse (for approximately 60 min) to review the NCI booklet Chemotherapy and You: Support for People With Cancer, which includes facts about chemotherapy and its side effects. They will be provided with NCI online resources to review at home.

Первичные конечные точки

• Difference between experimental and active comparator arms- Physical Function [Срок оценки: 12 Weeks]

Вторичные конечные точки (3)

• Difference between experimental and active comparator arms -Fatigue [Срок оценки: 12 Weeks]
• Difference between experimental and active comparator arms -Depression [Срок оценки: 12 Weeks]
• Difference between experimental and active comparator arms -Quality of Life [Срок оценки: 12 Weeks]

Критерии участия

Критерии включения

• Age ≥60 years (conventional definition of older age in clinical trials of MN)
• Have a diagnosis of MN
• Planned for or receiving outpatient cancer-directed treatments (participants receiving consolidative or maintenance outpatient therapies after induction chemotherapy are allowed to enroll)
• English speaking
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-3
• No medical contraindications for exercise per oncologist
• Able to walk 4 meters as part of Short Physical Performance Battery measured walk (with or without assistive device)
• Able to provide informed consent

Критерии исключения

• Physical, psychological, or social impairments that would interfere with subject's ability to participate in the study or participate in the intervention, as determined by the PI or the treating team

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

США · 1 центр

• University of Rochester Medical Center/Wilmot Cancer Institute — Rochester

Публикации

• Wang Y, Jensen-Battaglia M, Lin PJ, Kleckner I, Hayward E, Mendler J, Liesveld J, LoCastro M, Fallone Sharma C, Mortaz Hedjri S, Dunne R, Mustian K, Loh KP. Gait Changes After a Mobile Health Exercise Intervention in Older Adults With Myeloid Neoplasms: Single-Arm Pilot Trial. JMIR Cancer. 2026 Apr 29;12:e80909. doi: 10.2196/80909. PMID 42054674
• Loh KP, Sanapala C, Jensen-Battaglia M, Rana A, Sohn MB, Watson E, Gilmore N, Klepin HD, Mendler JH, Liesveld J, Huselton E, LoCastro M, Susiarjo M, Netherby-Winslow C, Williams AM, Mustian K, Vertino P, Janelsins MC. Exercise and epigenetic ages in older adults with myeloid malignancies. Eur J Med Res. 2023 May 30;28(1):180. doi: 10.1186/s40001-023-01145-z. PMID 37254221

Идентификаторы

NCT: NCT04981821 · UCCS21043 · R00CA237744

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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