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Alberta Cancer Exercise Dose in Colorectal Cancer (ACE-Dose-CRC)

27 ottobre 2026 aggiornato da: University of Calgary

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.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

90

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

    • Alberta
      • Calgary, Alberta, Canada, T2N 5G2
        • Arthur J.E. Child Comprehensive Cancer Centre - Gastrointestinal tumour group outpatient clinics
        • Contatto:
        • Contatto:
        • Investigatore principale:
          • Safiya Karim, MD
        • Sub-investigatore:
          • Patricia Tang, MD, FRCPC
        • Sub-investigatore:
          • Richard Lee-Ying, MD, MPH, FRCPC
        • Sub-investigatore:
          • David Langelier, MD, MSc, FRCPC
        • Sub-investigatore:
          • Marc Kerba, MD, FRCPC
        • Sub-investigatore:
          • Jongbok Lee, PhD
        • Sub-investigatore:
          • Rui Fu, PhD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.

Comparatore attivo: 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.

Nessun intervento: Control-waitlisted group (Arm 3)

Standard of care control-waitlisted group to start the Thrive program after 24 weeks on a voluntary basis

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
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.
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of participants with exercise-related adverse events with CTCAE standardized reports
Lasso di tempo: 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
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Changes from baseline in immunologic parameters at 8 weeks and 12-week follow-up.
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: S. Nicole Culos-Reed, PhD, University of Calgary

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 gennaio 2027

Completamento primario (Stimato)

1 gennaio 2028

Completamento dello studio (Stimato)

1 gennaio 2029

Date di iscrizione allo studio

Primo inviato

27 ottobre 2026

Primo inviato che soddisfa i criteri di controllo qualità

27 ottobre 2026

Primo Inserito (Effettivo)

3 novembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

3 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

27 ottobre 2026

Ultimo verificato

1 ottobre 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

No plan at this time to share IPD outside of research team

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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