FIRST-Sask Study Protocol: A Remote Exercise Oncology Intervention (FIRST-Sask)
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.
調査の概要
状態
条件
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Principle Investigator
- 電話番号：1-306-337-3817
- メール：schroder.sattar@usask.ca
参加基準
適格基準
就学可能な年齢
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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.
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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.
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介入なし：Control
Participants in the control arm will receive no intervention.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Feasibility (measurement by recruitment rate, adherence rate, retention rate, outcome capture rate)
時間枠：At Week 12 (end-of-intervention)
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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%).
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At Week 12 (end-of-intervention)
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Acceptability of program (measured using survey and open-ended interview)
時間枠：At Week 12 (end-of-intervention)
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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
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At Week 12 (end-of-intervention)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Cardiovascular endurance, measured using the 2-Minute Step Test and reported as the number of steps completed in two minutes.
時間枠：At baseline and at Week 12 (end-of-intervention)
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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.
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At baseline and at Week 12 (end-of-intervention)
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Upper limb muscle strength, measured using hand grip dynamometry and reported as maximal grip strength (in kilograms)
時間枠：At baseline and at Week 12 (end-of-intervention)
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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.
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At baseline and at Week 12 (end-of-intervention)
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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.
時間枠：At baseline and at Week 12 (end-of-intervention)
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Lower limb strength will be measured assessed using 30-second sit-stand.
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At baseline and at Week 12 (end-of-intervention)
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Balance, measured using the Single-Leg Stance Test and reported as the duration a participant can maintain single-leg standing.
時間枠：At baseline and at Week 12 (end-of-intervention)
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Balance will be assessed using the Single-leg Stance test.
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At baseline and at Week 12 (end-of-intervention)
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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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.
時間枠：At baseline and at Week 12 (end-of-intervention)
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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.
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At baseline and at Week 12 (end-of-intervention)
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- BIO 5554
- SHRF 6794 (その他の助成金/資金番号：Saskatchewan Health Research Foundation)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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