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

3. november 2026 oppdatert av: 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.

Studieoversikt

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

90

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.

Aktiv komparator: 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.

Ingen inngripen: Control-waitlisted group (Arm 3)

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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
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.
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of participants with exercise-related adverse events with CTCAE standardized reports
Tidsramme: 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
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Changes from baseline in immunologic parameters at 8 weeks and 12-week follow-up.
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. januar 2027

Primær fullføring (Antatt)

1. januar 2028

Studiet fullført (Antatt)

1. januar 2029

Datoer for studieregistrering

Først innsendt

27. oktober 2026

Først innsendt som oppfylte QC-kriteriene

27. oktober 2026

Først lagt ut (Faktiske)

3. november 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

6. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. november 2026

Sist bekreftet

1. oktober 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

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

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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