Sustainable Implementation of the EXCEL Exercise Oncology Program Across Canada (EXCEL)

October 2, 2025 updated by: University of Calgary

EXCEL will provide online and, where feasible, in-person exercise programs to individuals living with and beyond cancer (ILWBC). Research has shown that targeted programs that include tailored exercise prescriptions are more successful in helping individuals with chronic disease to incorporate physical activity and exercise into their daily routines. While ILWBC are advised by healthcare professionals (HCPs) to engage in exercise, there is a lack of cancer-specific exercise programs and cancer-trained exercise specialists in Canada, outside of the research setting. Considering the negative impact cancer and its treatments have on fitness and physical activity levels, community-based efforts towards improving access, uptake and maintenance of exercise programming are needed.

This study will evaluate the benefits of a community-based or online EXCEL exercise program for people living with and beyond cancer across Canada, using a streamlined intake process compared to the original EXCEL Study (HREBA.CC-20-0098, NCT04478851). This 8 to 12-week program (intervention) will be delivered in-person or over virtual platform. It includes twice weekly supervised exercise classes.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Over the past 4.5 years, the EXCEL Study (HREBA.CC-20-0098, NCT04478851) has been implemented across Canada and has recruited over 1500 individuals living with and beyond cancer. This updated study will streamline the program to essential baseline screening and testing (for safe and effective program delivery), simplify outcome assessments (for participants to see changes and for program evaluation), and increase the reach to include more urban centres to encourage more healthcare provider (HCP) buy-in with a simplified referral process (i.e. no patient screening required from HCPs to determine eligibility, based on location). This updated program is based off of the Alberta Cancer Exercise (ACE) Program (HREBA.CC-24-0252). Thus, we are modifying the original EXCEL ethics to will reduce the participant burden with less patient-reported-outcomes and fewer follow-ups, which will allow more focus on program implementation, evaluation, and sustainability. Continued effort and training to establish the clinic-to-community model will be enhanced with stronger relationships and referrals from the cancer care system and the HCPs, which will continue to work towards a 'patient-centered care approach'.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
740

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N1N4
        • Recruiting
        • University of Calgary
        • Principal Investigator:
          • Nicole Culos-Reed, PhD
        • Contact:
    • British Columbia
      • Vancouver, British Columbia, Canada, V6T 1Z7
        • Recruiting
        • University of British Columbia
        • Contact:
        • Principal Investigator:
          • Kristin Campbell, PhD
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 4R2
        • Recruiting
        • Nova Scotia Health Authority
        • Contact:
        • Principal Investigator:
          • Melanie Keats, PhD
    • Ontario
      • Toronto, Ontario, Canada, M5S 1A1
        • Recruiting
        • University of Toronto
        • Contact:
        • Principal Investigator:
          • Daniel Santa Mina, PhD
        • Principal Investigator:
          • Linda Trinh, PhD
    • Quebec
      • Montreal, Quebec, Canada, H2X 0A9
        • Recruiting
        • Centre Hospitalier de L'Universite de Montreal
        • Contact:
        • Principal Investigator:
          • Isabelle Doré, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • have or had a diagnosis of cancer;
  • be 18 years or older;
  • be able to participate in low-intensity levels of activity, at minimum;
  • be pretreatment, or receiving active cancer treatment (i.e., surgery, systemic therapy and radiation therapy), have received cancer treatment within the past 3 years, or if beyond 3 years since treatment completion, have a referral from their healthcare team indicating they have side effects from cancer treatment or the cancer itself, that could be improved or managed with exercise;
  • be able to provide informed written consent in English or French

Exclusion Criteria:

  • does not or did not have a cancer diagnosis
  • is under the age of 18
  • is unable to participate in mild exercise, at minimum
  • is not pretreatment, or receiving active cancer treatment (i.e., surgery, systemic therapy and radiation therapy), has not received cancer treatment within the past 3 years, or if beyond 3 years since treatment completion, doesn't have side effects from cancer treatment or the cancer itself, that could be improved or managed with exercise
  • unable to read/write in English
  • for online programs, does not have internet or computer access

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention
All participants will be involved in group exercise classes, twice a week for 8-12 weeks.
Behavioral: Group Exercise Classes
Participants will take part in a combination of aerobic, resistance, balance, and flexibility exercises delivered in a circuit-type class setting, twice weekly for a 8-12-week period (duration of intervention depends on scheduling logistics for the coordinating hubs and their spokes sites). The exercise sessions will be conducted in groups with a ratio of up to 15 participants per instructor. The program follows exercise progression principles (i.e., frequency, intensity, time, type, overload and progression) over the 8-12-weeks, with tailoring of any exercise to meet individual participant needs as required, in order to promote fitness and wellness benefits.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Physical Activity Level
Time Frame: Baseline to one year
The Modified Godin Leisure Time Exercise Questionnaire is used to determine subjective levels of physical activity in each participant.
Baseline to one year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Program implementation and evaluation
Time Frame: Baseline to one year
RE-AIM: program reach, effectiveness, adoption, implementation and maintenance
Baseline to one year
Cancer related symptoms
Time Frame: Baseline to one year
Change in Edmonton Symptom Assessment Scale - revised: cancer. Scale is from 0-10, where 0 means the symptom is absent and 10 means the worst possible severity of the symptom is being experienced.
Baseline to one year
Cost-effectiveness
Time Frame: Baseline to one year
Change in EuroQual - 5Dimensions (EQ-5D) tool - first section is a questionnaire; last section uses a scale from 0-100, where 0 means the worst health imaginable and 100 means the best health imaginable.
Baseline to one year
Fatigue
Time Frame: Baseline to one year
Change in Functional Assessment of Chronic Illness Therapy - Fatigue subscale - scale is from 0-4, where 0 means "not at all" and 4 means "very much".
Baseline to one year
Quality of life
Time Frame: Baseline to one year
Single-item measure on quality of life - scale from 0 to 100, where 100 means the best Quality of Life imaginable and 0 means the worst Quality of Life imaginable.
Baseline to one year
Body Composition
Time Frame: Baseline to 12-weeks
Change in body mass index (BMI)
Baseline to 12-weeks
Aerobic Capactiy
Time Frame: Baseline to 12-weeks
Change in 6-minute walk test (m) or 2 minute step test (steps) results
Baseline to 12-weeks
Lower body strength
Time Frame: Baseline to 12-weeks
Change in sit-to-stand (number of repetitions in 30 seconds)
Baseline to 12-weeks
Upper extremity flexibility
Time Frame: Baseline to 12-weeks
Change in active shoulder flexion range of motion (degrees)
Baseline to 12-weeks
Balance
Time Frame: Baseline to 12-weeks
Change in one legged stance test (seconds)
Baseline to 12-weeks
Exercise adherence
Time Frame: Duration of the intervention (8-12 week exercise program)
Adherence to exercise programming (attendance at sessions)
Duration of the intervention (8-12 week exercise program)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Calgary

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of British Columbia
Alberta Health services
University of Alberta
Centre hospitalier de l'Université de Montréal (CHUM)
University of Toronto
Nova Scotia Health Authority
Dalhousie University
University of Prince Edward Island
Memorial University of Newfoundland

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nicole Culos-Reed, PhD, University of Calgary

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 11, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 4, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 7, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 7, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 2, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HREBA.CC-25-0029

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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