Alberta Cancer Exercise Dose in Colorectal Cancer (ACE-Dose-CRC)
The purpose of this pilot randomized, wait-list controlled study is to evaluate the effects of exercise dose in terms of frequency (1 vs. 2 days per week) in individuals on systemic treatment for colorectal cancer. The impact on the individual (physical function, quality of life, fatigue and other patient reported outcomes) as well as on health care utilization (cost to deliver, cost to individuals, savings and impact to the health care system) will be evaluated. In addition, assessments of immunological markers to better understand the biological impact of exercise dose on immunological markers will be explored.
調査の概要
詳細な説明
Background and Rationale: There is a growing interest in optimizing exercise strategies that can enhance the well-being of individuals living with and beyond cancer (ILWBC). ILWBC frequently experience declines in physical function and QoL during and after treatment, and exercise is one of the few interventions consistently shown to address these challenges. This is of particular importance for individuals living with colorectal cancers, who face fluctuating treatment effects and often struggle to adhere to higher volumes of exercise. Many exercise oncology programs are standardized to reach guidelines levels of 90 or 150 minutes per week (ie, approximately 2-3 sessions/week), and this dose of exercise can impact both attendance (adherence to the sessions) as well as the effectiveness (outcomes, physical, fitness, and psychosocial). Questions thus remain about the most effective, practical, and sustainable "dose" - the frequency of supervised exercise - required to achieve meaningful benefits. In addition, there are questions of sustainability of delivering exercise within cancer care. The dose is thus a critical issue to examine, not only for feasibility of attendance by ILWBC and their anticipated benefits, but also in terms of the economics. There is a paucity of literature examining the economics of exercise dose (cost to deliver based on times per week), as well as a general lack of understanding the health economics (cost to deliver, cost to individuals, savings and impact on the cancer care system).
In Calgary, we have the existing ACE program (now called the Thrive Cancer Exercise Program) which offers participants a 12-week exercise oncology program with 2 classes per week. The original ACE study, baseline characteristics, and initial examination of program impact highlight the value of the ACE exercise intervention for ILWBC. This published work has resulted in streamlining ACE to program implementation and evaluation (HREBA.CC-24-0252). With increased clinical referral, the waitlist to the ongoing Thrive Cancer Exercise Program is growing. There is thus a pragmatic need to establish the optimal dose of exercise, to determine if a sustainable model of one class per week is sufficient to garner potential benefits and meet the growing clinical demand, as well as optimize health care costs and savings.
Research Question and Objectives: The purpose of this study is to evaluate the effects of exercise dose in terms of frequencies (one vs. two days per week) in individuals on treatment for colorectal cancer. The impact not only on the individual (potential benefits of exercise), but also in terms of cost will be assessed. In addition, assessments of immunological markers, physical function, QoL, fatigue, symptoms and exercise experience will occur.
Methods: This RCT study is a three-arm, parallel-group trial delivered through the Thrive Cancer Exercise Program at the Arthur J.E. Child Comprehensive Cancer Centre (ACCCC) Stride Centre and Rehab gym. Participants will be randomized (1:1:1) to: 1) Once/week (n = 30); 2) Twice/week for 12 weeks (n = 30); 3) Control-waitlisted to start Thrive Cancer Exercise Program after study completion (n = 30).
ACE-Dose classes will be delivered by Clinical Exercise Physiologists (CEPs) trained to lead high-risk participant classes. The program is a combination of aerobic, resistance, balance, and flexibility exercises delivered in group circuit-style class. The Thrive Cancer Exercise Program current infrastructure and referral process will be used.
Baseline, 12 weeks, 24 weeks and 52 weeks assessments will be done. The following information will be collected: 1) Attendance and Adverse event; 2) Health economics (work and productivity, time and income loss, informal care and daily impact, treatment attendance and travel, out-of-pocket costs, and medications and cost for cancer); 3) Bloodwork conducted by a phlebotomist to assess Immunological markers; 4) Patient-reported outcomes through standardized questionnaires (Quality of life, Fatigue, Symptom management, Exercise Barriers and Facilitators); 5) Physical activity & function assessments (Subjective Physical activity level, Cardiorespiratory fitness, Musculoskeletal fitness, Flexibility, Balance, and Anthropometrics); 6) Garmin data (step counts per day and heart rate) to assess objective Physical Activity Level; 7) Qualitative interview on Program experience.
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究連絡先
- 名前:Aude-Marie Foucaut, PhD
- 電話番号:403-210-8482
- メール:audemarie.foucaut@ucalgary.ca
研究場所
-
-
Alberta
-
Calgary、Alberta、カナダ、T2N 5G2
- Arthur J.E. Child Comprehensive Cancer Centre - Gastrointestinal tumour group outpatient clinics
-
コンタクト:
- Safiya Karim, MD
- 電話番号:403-521-3166
- メール:karis@ucalgary.ca
-
コンタクト:
- Aude-Marie Foucaut Beaucage, PhD
- 電話番号:403-210-8482
- メール:audemarie.foucaut@ucalgary.ca
-
主任研究者:
- Safiya Karim, MD
-
副調査官:
- Patricia Tang, MD, FRCPC
-
副調査官:
- Richard Lee-Ying, MD, MPH, FRCPC
-
副調査官:
- David Langelier, MD, MSc, FRCPC
-
副調査官:
- Marc Kerba, MD, FRCPC
-
副調査官:
- Jongbok Lee, PhD
-
副調査官:
- Rui Fu, PhD
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Adults (≥18)
- Have a primary biopsy-proven diagnosis of colon or rectal adenocarcinoma and undergoing adjuvant systemic treatment
- Cleared for exercise (PAR-Q+)
- Able to attend scheduled sessions
- Able to provide informed written consent in English.
- Not meeting current aerobic exercise guidelines (i.e. performing < 90 minutes of moderate to vigorous physical activity per week in the past month)
Exclusion Criteria:
- Participants who have completed adjuvant treatment for CRC
- Unstable cardiopulmonary disease
- Uncontrolled hypertension
- Active infection
- Recent autoimmune flare
- Contraindication to needles/venipuncture
- Grade 2 or higher diarrhea secondary to systemic treatment
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 |
|---|---|
|
実験的:Once/week exercise session for 12 weeks (Arm 1)
Arm 1 will be supervised by a CEP once a week (e.g. Tuesday or Thursday) at the ACCCC. The exercise program includes aerobic, strength and balance / flexibility exercises for 12 week. |
Interventional arm 1 complete the supervised 60-min exercise classes for 12 weeks at low-to-moderate intensity, progressing individually (warm-up, aerobic intervals, multi-joint resistance, balance/flexibility cool-down), once-weekly. Sessions are delivered in-person by a CEP at the ACCCC Stride Centre. Attendance, RPE, and any modifications/adverse events are logged each session. In addition to exercise, 5 behaviour components will be covered throughout the program using an "Exercise and Educate" model, to support behaviour change. The trained instructor will build a positive motivational climate utilizing training in health coaching and motivational interviewing. |
|
アクティブコンパレータ:Twice/week exercise session for 12 weeks (Arm 2)
Arm 2 will be supervised by a CEP twice a week (e.g. Tuesday and Thursday) at the ACCCC. The exercise program includes aerobic, strength and balance / flexibility exercises for 12 week. |
Interventional arm 2 complete the supervised 60-min exercise classes for 12 weeks at low-to-moderate intensity, progressing individually (warm-up, aerobic intervals, multi-joint resistance, balance/flexibility cool-down), twice-weekly. Sessions are delivered in-person by a CEP at the ACCCC Stride Centre. Attendance, RPE, and any modifications/adverse events are logged each session. In addition to exercise, 5 behaviour components will be covered throughout the program using an "Exercise and Educate" model, to support behaviour change. The trained instructor will build a positive motivational climate utilizing training in health coaching and motivational interviewing. |
|
介入なし:Control-waitlisted group (Arm 3)
Standard of care control-waitlisted group to start the Thrive program after 24 weeks on a voluntary basis |
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 |
|---|---|---|
|
Proportion of patients in the once per week and twice per week group that achieve an increase of ≥10 MET-h/wk of total physical activity level at 12 weeks.
時間枠:Single time point: 12 weeks
|
To assess the dose-response effect of exercise frequency (once versus twice weekly) over a 12-week period on clinically meaningful improvements in physical activity level (≥10 MET-h/wk increase over baseline) in patients with early-stage CRC receiving systemic treatment, with the goal of identifying the minimal effective intervention frequency |
Single time point: 12 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of participants with exercise-related adverse events with CTCAE standardized reports
時間枠:From enrollment to 24 weeks
|
To assess safety of the once per week versus twice per week supervised exercise |
From enrollment to 24 weeks
|
|
Difference in health economic and health care utilization between groups over 52 weeks
時間枠:From enrollment to 52 weeks
|
Indirect costs of cancer, work and productivity, time and income loss, informal care and daily impact, treatment attendance and travel, out-of-pocket costs, medications and cost for cancer treatment, emergency department admissions, and hospitalizations |
From enrollment to 52 weeks
|
|
Changes from baseline in the PROs at 12 weeks, and at 24- and 52-week follow-ups.
時間枠:From enrollment to the end of the study at 52 weeks
|
Assess changes in patient-reported outcomes (PROs) - including quality of life, functional abilities, cognitive function, well-being, fatigue, and symptoms - from the start of the study through the end of the intervention, and then at follow-up visits. |
From enrollment to the end of the study at 52 weeks
|
|
Changes from baseline in anthropometric parameters and fitness level at 12 weeks, and at the 24- and 52-week follow-ups.
時間枠:From enrollment to the end of the study at 52 weeks
|
Assess changes in anthropometric parameters (height and weight) and physical fitness - including cardiorespiratory fitness, musculoskeletal fitness, flexibility and balance - from the start of the study through the end of the intervention, and then at follow-up visits. |
From enrollment to the end of the study at 52 weeks
|
|
Changes from baseline in objective physical activity level at 12 weeks, and at the 24-week follow-up.
時間枠:From enrollment to 24 weeks
|
Assess step count and heart rate, as per the Garmin fitness tracker watch data. Participants will be asked to wear the tracker for at least 10 hours per day for 24 weeks, unless the device is charging. |
From enrollment to 24 weeks
|
|
Participant experience and perceived tolerability of the ACE-dose program at 12 weeks
時間枠:Single time point: 12 weeks
|
Assess participant experience of the ACE-dose program, including overall experience and manageability and tolerability of treatment-related side effects during the program with semi-structured interviews at 12 weeks. |
Single time point: 12 weeks
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Changes from baseline in immunologic parameters at 8 weeks and 12-week follow-up.
時間枠:From enrollment to 8 and 12 weeks
|
Explore biologic mechanisms of exercise through changes in peripheral immune cell composition, particularly T-cell subsets. These endpoints may clarify whether exercise dose is associated with immunologic changes relevant to CRC outcomes and patient-reported benefit. |
From enrollment to 8 and 12 weeks
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:S. Nicole Culos-Reed, PhD、University of Calgary
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
- HREBA.CC-26-0061
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?
IPD プランの説明
No plan at this time to share IPD outside of research team
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。