- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07913906
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.
연구 개요
상태
상세 설명
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, the principal investigator have developed 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.
연구 유형
등록 (추정된)
단계
- 2 단계
연락처 및 위치
연구 연락처
- 이름: Aude-Marie Foucaut, PhD
- 전화번호: 403-210-8482
- 이메일: audemarie.foucaut@ucalgary.ca
연구 장소
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Alberta
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Calgary, Alberta, 캐나다, T2N 5G2
- Arthur J.E. Child Comprehensive Cancer Centre - Gastrointestinal tumour group outpatient clinics
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연락하다:
- Safiya Karim, MD
- 전화번호: 403-521-3166
- 이메일: karis@ucalgary.ca
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연락하다:
- Aude-Marie Foucaut Beaucage, PhD
- 전화번호: 403-210-8482
- 이메일: audemarie.foucaut@ucalgary.ca
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수석 연구원:
- Safiya Karim, MD
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부수사관:
- Patricia Tang, MD, FRCPC
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부수사관:
- Richard Lee-Ying, MD, MPH, FRCPC
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부수사관:
- David Langelier, MD, MSc, FRCPC
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부수사관:
- Marc Kerba, MD, FRCPC
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부수사관:
- Jongbok Lee, PhD
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부수사관:
- Rui Fu, PhD
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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. |
|
활성 비교기: 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. |
|
간섭 없음: Control-waitlisted group (Arm 3)
Standard of care control-waitlisted group to start the Thrive program after 24 weeks on a voluntary basis |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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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.
기간: Single time point: 12 weeks
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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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of participants with exercise-related adverse events with CTCAE standardized reports
기간: From enrollment to 24 weeks
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To assess safety of the once per week versus twice per week supervised exercise |
From enrollment to 24 weeks
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Difference in health economic and health care utilization between groups over 52 weeks
기간: From enrollment to 52 weeks
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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
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Changes from baseline in the PROs at 12 weeks, and at 24- and 52-week follow-ups.
기간: From enrollment to the end of the study at 52 weeks
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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
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Changes from baseline in anthropometric parameters and fitness level at 12 weeks, and at the 24- and 52-week follow-ups.
기간: From enrollment to the end of the study at 52 weeks
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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
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Changes from baseline in objective physical activity level at 12 weeks, and at the 24-week follow-up.
기간: From enrollment to 24 weeks
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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
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Participant experience and perceived tolerability of the ACE-dose program at 12 weeks
기간: Single time point: 12 weeks
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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
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Changes from baseline in immunologic parameters at 8 weeks and 12-week follow-up.
기간: From enrollment to 8 and 12 weeks
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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
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공동 작업자 및 조사자
수사관
- 수석 연구원: S. Nicole Culos-Reed, PhD, University of Calgary
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- HREBA.CC-26-0061
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
No plan at this time to share IPD outside of research team
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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