FIRST-Sask Study Protocol: A Randomized Controlled Trial of a Remote Exercise Oncology Intervention
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 37
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —(Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
- •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.
排除标准
- •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.
研究者
Schroder Sattar
Associate Professor
University of Saskatchewan
