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FIRST-Sask Study Protocol: A Remote Exercise Oncology Intervention (FIRST-Sask)

2026年5月28日 更新者：Schroder Sattar、University of Saskatchewan

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

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.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

37

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：支持治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：Intervention group
The online exercise sessions will be delivered via Zoom, led by 2 certified exercise trainers. The program will span 12 weeks, with 2 sessions per week. Each session will be 60 min in duration and will include: warm-up (breathing exercise and joint mobility, 5 min); circuit-style training encompassing aerobic, balance, and resistance training (45-50 min), and cool-down. Individual progressions will be titrated based on abilities. Exercise intensity will be monitored using the 10-point Borg Rating of Perceived Exertion (RPE) scale. To provide some form of flexibility within this study, participants who would like to occasionally attend some of their sessions in-person will have option to informing the trainers 48 hours in advance to arrange an in-person session.
行为的：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.
无干预：Control
Participants in the control arm will receive no intervention.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Feasibility (measurement by recruitment rate, adherence rate, retention rate, outcome capture rate)
大体时间：At Week 12 (end-of-intervention)
Feasibility of the intervention will be measured using attendance rate (attending ≥50% of sessions), adherence rate (adhering to ≥50% of the prescribed exercises), retention rate (≥50%), and outcome capture (≥80%).
At Week 12 (end-of-intervention)
Acceptability of program (measured using survey and open-ended interview)
大体时间：At Week 12 (end-of-intervention)
Acceptability will be assessed using the CSQ-8 tool that assesses satisfactory level about the program. It contains 8 items, each item is scored from 1 to 4. Higher scores indicate greater satisfaction. There will also be open-ended questions to share feedback as well as recommendations for improvement for further participants, their perceived benefits about the program regarding quality of life and general well-being, and likelihood to recommend it to other cancer survivors. The optional exit interview with provide participants with opportunity to share in more depth about their experiences, and
At Week 12 (end-of-intervention)

次要结果测量

结果测量
措施说明
大体时间
Cardiovascular endurance, measured using the 2-Minute Step Test and reported as the number of steps completed in two minutes.
大体时间：At baseline and at Week 12 (end-of-intervention)
Cardiovascular endurance will be assessed using the 2-min Step Test, a validated measure of cardiovascular endurance. For online assessment, participants will be instructed to stand perpendicular to the camera (i.e., with their side and either the left or right leg facing the camera); the number of steps completed by the leg facing the camera during the 2-minute test will be recorded.
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)
大体时间：At baseline and at Week 12 (end-of-intervention)
Upper limb muscle strength will be measured using hand grip strength test with a Jamar dynamometer, which is considered the gold standard for measuring grip strength.
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.
大体时间：At baseline and at Week 12 (end-of-intervention)
Lower limb strength will be measured assessed using 30-second sit-stand.
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.
大体时间：At baseline and at Week 12 (end-of-intervention)
Balance will be assessed using the Single-leg Stance test.
At baseline and at Week 12 (end-of-intervention)

其他结果措施

结果测量
措施说明
大体时间
Health-related quality of life, measured using the 30-item EORTC QLQ-C30 and reported as domain and symptom scores reflecting physical, social, emotional, and cognitive functioning, symptom burden, and overall quality of life.
大体时间：At baseline and at Week 12 (end-of-intervention)
Health-related quality of life will be measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). The EORTC QLQ-C30 is a 30-item questionnaire that generates scores transformed to a 0-100 scale for functional domains, symptom domains, and global health status/quality of life. Higher scores on the functional and global health status/quality of life scales indicate better functioning and quality of life, whereas higher scores on the symptom scales indicate greater symptom burden and worse outcomes.
At baseline and at Week 12 (end-of-intervention)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University of Saskatchewan

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年5月1日

初级完成 (估计的)

2027年3月30日

研究完成 (估计的)

2027年7月30日

研究注册日期

首次提交

2026年5月7日

首先提交符合 QC 标准的

2026年5月28日

首次发布 (实际的)

2026年6月1日

研究记录更新

最后更新发布 (实际的)

2026年6月1日

上次提交的符合 QC 标准的更新

2026年5月28日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

其他研究编号

  • BIO 5554
  • SHRF 6794 (其他赠款/资助编号：Saskatchewan Health Research Foundation)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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