From Exercise Oncology Research to Clinical Practice

Официальное название

Bridging the Gap Between Exercise Oncology Research and Its Implementation in Clinical Practice

Обзор

Building on previous research that shows the benefits of exercise, this study aims to find out how best to implement exercise in real-world settings. The study will assess the feasibility and acceptability of an embedding an automated referral tool and an exercise professional into standard cancer care impacts clinician referral and patient uptake of exercise programming. The study will assess how effective the exercise program is at improving patients' physical health, quality of life, symptom management, and overall wellbeing during different stages of their cancer journey (e.g., before treatment, on treatment, after treatment).

Подробное описание

The ICARE study is a comprehensive hybrid Type 3 effectiveness-implementation trial aimed at evaluating the integration of an evidence-based exercise program into routine cancer care in real-world clinical settings. Its primary focus is on understanding the feasibility, acceptability, and practical aspects of implementing this intervention through the application of targeted implementation strategies, including the automation of referrals into the clinical workflow to streamline and standardize the process. Specifically, the study assesses the extent of program adoption at multiple levels: first, at the clinician level by measuring the proportion and representativeness of oncology care providers who refer patients to the exercise program; second, at the clinic level by evaluating the proportion and diversity of cancer centers and community clinics that successfully incorporate the exercise intervention into their standard workflows; and third, at the patient level by examining the reach of the program, including the number, proportion, and demographic diversity of participating patients. The study also seeks to identify contextual factors, such as organizational culture, resources, and clinician attitudes, as well as barriers and facilitators that influence successful implementation and sustainment of the program.

While the primary focus is on implementation, the study also has a secondary aim to evaluate the clinical effectiveness of the tailored, evidence-based exercise intervention on important patient-centered outcomes. These include improvements in physical functioning, enhancements in quality of life, better symptom management, and overall wellbeing, measured across various stages of the post-diagnosis cancer journey (i.e., pretreatment/prehabilitation, active treatment, post-treatment/rehabilitation/early survivorship. Ultimately, the findings from this study aim to inform future implementation strategies, optimize integration processes, and improve patient outcomes by translating evidence-based practices into sustainable, real-world cancer care settings.

Вмешательства

• Другое Exercise
  PRE-TREATMENT: Frequency: 2-3 supervised exercise sessions/week (45-60 min/session) with 30 minutes of walking on non-supervised days. Intensity: Rating of Perceived Exertion (RPE) 5-7/10. Type: Multimodal (aerobic + resistance training). Time: 3 to 12 weeks of supervised exercise. ON TREATMENT: Frequency: 2 supervised exercise sessions/week (45-60 min/session) with 30 minutes of walking on non-supervised days. Intensity: RPE 3-5/10. Type: Multimodal (aerobic + resistance training). Time: 12 we

Первичные конечные точки

• Implementation [Reach] [Срок оценки: 12 months, 24 months, 36 months]
• Implementation [Adoption] [Срок оценки: 12 months, 24 months, 36 months]
• Implementation Outcomes [Срок оценки: 6 months, 12 months, 18 months, 24 months, 30 months, 36 months]
• Implementation [Maintenance] [Срок оценки: 12 months, 24 months, 36 months]
• Implementation [Cost Effectiveness] [Срок оценки: 36 months]

Вторичные конечные точки (7)

• Effectiveness [Quality of Life] [Срок оценки: Baseline, 12 weeks, 16 weeks]
• Effectiveness [Physical Activity] [Срок оценки: Baseline, 12 weeks, 16 weeks]
• Effectiveness [Symptom Burden] [Срок оценки: Baseline, 12 weeks, 16 weeks]
• Effectiveness [Participant Satisfaction] [Срок оценки: 12 weeks, 16 weeks]
• Effectiveness [Physical Fitness] [Срок оценки: Baseline, 12 weeks, 16 weeks]
• Effectiveness [Functional Capacity] [Срок оценки: Baseline, 12 weeks]
• Effectiveness [Treatment Related Complications] [Срок оценки: Baseline, 12 weeks]

Критерии участия

Критерии включения

• Have received a cancer diagnosis (inclusive of primary, recurrent; and/or metastatic disease);
• Over the age of 19 years;
• Able to participate in mild levels of activity as a minimum;
• Be pretreatment, or receiving active cancer treatment, or have received cancer treatment within the past six months and are still under active oncology care, or beyond six months if they continue to be under active oncology care;
• Able to provide informed written consent in English; and
• Have access to internet service and a device that can support video calling (for online programs).

Критерии исключения

• Severe cognitive, physical, psychiatric, or uncontrolled medical condition(s) resulting in an inability to provide consent and/or safely participate in the study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Канада · 1 центр

• Physical Activity & Cancer Lab — Halifax

Идентификаторы

NCT: NCT07635589 · PAC ICare

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗