Internet-Based Lifestyle Intervention to Eradicate Obese Frailty in Prostate Cancer Survivors, iLIVE

Официальное название

Internet-Based Lifestyle Intervention to Eradicate Obese Frailty in Prostate Cancer Survivors (iLIVE)

Обзор

This clinical trial tests the effectiveness of an online weight loss plus resistance training intervention (iLIVE) to decrease obesity and improve frailty in men with prostate cancer who received androgen deprivation therapy (ADT). Androgen deprivation therapy increases the risk of frailty, weight gain and obesity in prostate cancer survivors. The combination of frailty and obesity can lead to a decrease in quality of life and an increased risk of recurrent falls. Using iLIVE may improve obesity and frailty in men with prostate cancer who receive ADT.

Подробное описание

PRIMARY OBJECTIVE:

I. To test the effectiveness of a combined online weight loss plus resistance training intervention (iLIVE) on obese frailty in prostate cancer survivors (PCS) on ADT.

SECONDARY OBJECTIVES:

I. To understand the effect of iLIVE on health behaviors, physical functioning, and quality of life II. To understand facilitators and barriers to implementing iLIVE in clinical and community practice

OUTLINE: Patients are randomized to arm I or II. Key stakeholders are identified for implementation outcomes

ARM I: Patients receive online access to an interactive weight loss website and participate in online group based resistance training sessions (iLIVE) on study. Patients also use a Fitbit fitness tracker and Aria (registered trademark) smart scale while on study.

ARM II: Patients receive usual care with access to online survivorship and exercise recommendations and use a Fitbit fitness tracker and Aria (registered trademark) smart scale while on study.

Patients are followed for 6 months after completion of intervention.

Key stakeholders complete an interview while on study to assess barriers and facilitators to implementation of iLIVE into clinical practice.

Вмешательства

• Другое Internet-Based Exercise Intervention
  Participate in online supervised, group resistance training sessions (iLIVE)
• Другое Internet-Based Diet Intervention
  Receive online access to an interactive website with a series of weekly self-directed and interactive sessions on various topics associated with diet and weight loss (iLIVE)
• Другое Education Intervention
  Receive usual care receiving educational information about diet and exercise for cancer survivors

Первичные конечные точки

• Change in overweight/obesity [Срок оценки: At baseline, 3 months, 6 months and 12 months]
• Change in sarcopenia [Срок оценки: At baseline and 6 months]
• Change in slowness [Срок оценки: At baseline, 3 months and 6 months]
• Change in weakness [Срок оценки: At baseline, 3 months, and 6 months]
• Change in inactivity [Срок оценки: At baseline, 3 months, 6 months, and 12 months]
• Change in fatigue [Срок оценки: At baseline, 3 months, 6 months, and 12 months]

Вторичные конечные точки (3)

• Change in health behaviors [Срок оценки: At baseline, 3 months, 6 months, and 12 months]
• Change in physical functioning [Срок оценки: At baseline, 3 months, 6 months, 12 months]
• Change in quality of life [Срок оценки: At baseline, 3 months, 6 months, and 12 months]

Критерии участия

Критерии включения

• INTERVENTION PARTICIPANTS: Age 18 or older
• INTERVENTION PARTICIPANTS: Diagnosed with histologically confirmed prostate cancer
• INTERVENTION PARTICIPANTS: Received \>= 6 months of ADT any time in the past 10 years
• INTERVENTION PARTICIPANTS: Completed radiotherapy, chemotherapy and/or surgery \> 6 weeks prior to
• INTERVENTION PARTICIPANTS: No intent to start adjuvant chemotherapy or radiotherapy within 6 months of enrollment
• INTERVENTION PARTICIPANTS: Overweight or obese (body mass index \> 25 kg/m2 to BMI ≤ 50).
• INTERVENTION PARTICIPANTS: Evidence of frailty by meeting three or more of the following frailty criteria: weakness, slowness, fatigue, inactivity, and/or illness
• INTERVENTION PARTICIPANTS: Not currently engaging in structured diet or resistance strength training exercise program
• INTERVENTION PARTICIPANTS: Willing to be randomized into either study arm and adhere to study protocol
• INTERVENTION PARTICIPANTS: Home internet sufficient for videoconferencing
• INTERVENTION PARTICIPANTS: Signed informed consent
• IMPLEMENTATION PARTICIPANTS: Be a key stakeholder (i.e., healthcare provider or administrative, or intervention participant \[completers, partial completers, or no participation\])
• IMPLEMENTATION PARTICIPANTS: Verbal informed consent following receipt of an information sheet

Критерии исключения

• INTERVENTION PARTICIPANTS: Unintentional weight loss \> 5% within the last year
• INTERVENTION PARTICIPANTS: Contraindication to moderate intensity exercise
• INTERVENTION PARTICIPANTS: Health or medical condition that affects weight status/body composition (e.g., Cushing's syndrome, uncontrolled hyper-/hypo- thyroidism)
• INTERVENTION PARTICIPANTS: Active malignancy (other than non-melanoma skin cancer)
• INTERVENTION PARTICIPANTS: Not fluent in English and therefore incapable of answer survey questions, following directions during exercise or performance testing, and providing informed consent in English
• INTERVENTION PARTICIPANTS: Currently taking or have taken creatine supplement in the month preceding baseline creatine testing

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

• OHSU Knight Cancer Institute — Portland

Публикации

• Demark-Wahnefried W, Rogers LQ, Zubkoff L, Pisu M, Hung A, Graff JN, Hamilton J, Dieckmann NF, Winters-Stone K. Protocol for the internet-based lifestyle intervention to eradicate obese frailty in prostate cancer survivors (iLIVE) randomized controlled trial: a type I hybrid effectiveness implementation trial. BMC Cancer. 2026 Mar 25;26(1):559. doi: 10.1186/s12885-026-15851-4. PMID 41882641

Идентификаторы

NCT: NCT06011499 · STUDY00025281 · R01CA275055 · NCI-2023-03141 · STUDY00025281

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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