FIRST-Sask Study Protocol: A Remote Exercise Oncology Intervention

Официальное название

FIRST-Sask Study Protocol: A Randomized Controlled Trial of a Remote Exercise Oncology Intervention

Обзор

Older adults undergoing cancer treatment experience substantial treatment-related burden and reduced quality of life (QoL). Exercise is an effective supportive care intervention, but access is limited in rural and geographically dispersed settings. Evidence on flexible delivery models that accommodate patient preferences and real-world constraints remains scarce. This study seeks to evaluate the feasibility and acceptability of a hybrid exercise program for older adults with cancer in rural settings and to obtain preliminary efficacy estimates to inform a larger trial. This randomized controlled trial tests a 12-week, multimodal exercise intervention co-designed with patient partners. The program uses a hybrid delivery model with options (in-person, remote, or combined formats) based on preference, geography, season, and alignment with routine travel (e.g. clinic visits). Older adults (≥65) with breast, lung, prostate, colorectal, or hematologic cancers are recruited using a multipronged strategy. Assessments at baseline and 12 weeks include cardiovascular endurance, upper and lower limb strength, balance, and QoL. Feasibility and acceptability will be examined via recruitment, retention, adherence, exit surveys and interviews. Exercise prescription will follow FITT principles. Adherence, dose modifications, and fidelity will be monitored using standardized procedures. Analyses will follow an intention-to-treat approach, with between-group and over-time effects estimated using generalized linear and mixed-effects models. This study will inform the development of a scalable exercise rehabilitation model to improve equitable access to supportive care in rural settings.

Вмешательства

• Поведенческое FIRST-Sask Study (Feasibility & acceptabIlity of canceR exerciSe inTervention - a Saskatchewan study)
  The 12- week intervention entails 2x weekly synchronous exercise sessions, delivered via Zoom and facilitated by two certified exercise trainers. Each session is 60 min in duration and includes multimodal exercises.

Первичные конечные точки

• Feasibility (measurement by recruitment rate, adherence rate, retention rate, outcome capture rate) [Срок оценки: At Week 12 (end-of-intervention)]
• Acceptability of program (measured using survey and open-ended interview) [Срок оценки: At Week 12 (end-of-intervention)]

Вторичные конечные точки (4)

• Cardiovascular endurance, measured using the 2-Minute Step Test and reported as the number of steps completed in two minutes. [Срок оценки: At baseline and at Week 12 (end-of-intervention)]
• Upper limb muscle strength, measured using hand grip dynamometry and reported as maximal grip strength (in kilograms) [Срок оценки: At baseline and at Week 12 (end-of-intervention)]
• Lower limb muscle strength, measured using the 30-Second Sit-to-Stand Test and reported as the number of full sit-to-stand repetitions completed in 30 seconds. [Срок оценки: At baseline and at Week 12 (end-of-intervention)]
• Balance, measured using the Single-Leg Stance Test and reported as the duration a participant can maintain single-leg standing. [Срок оценки: At baseline and at Week 12 (end-of-intervention)]

Критерии участия

Критерии включения

• confirmed diagnosis of any type of cancer (except non-melanoma skin cancer);
• having received cancer treatment within the past 12 months;
• self-identifying as rural resident; or residing in areas outside of the city of Saskatoon or Regina;
• age ≥65;
• ability to communicate in English;
• ability to provide informed consent;
• physically suitable to participate by research personnel based on PAR-Q and physical performance screening.

Критерии исключения

• persistent light-headedness during physical activity of or syncopal episodes within the past month;
• other comorbidities or musculoskeletal complications that preclude participation in the exercise programs as deemed by the exercise interventionist;
• unstable bone metastases.

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07617220 · BIO 5554 · SHRF 6794

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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