- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06960291
- Original Trial
Sustainable Implementation of the EXCEL Exercise Oncology Program Across Canada (EXCEL)
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
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Julianna Dreger, PhD
- Phone Number: (403) 210-8482
- Email: jdreger@ucalgary.ca
Study Contact Backup
- Name: Georgia Kaluznick
- Phone Number: 403-210-8482
- Email: wellnesslab@ucalgary.ca
Study Locations
-
-
Alberta
-
Calgary, Alberta, Canada, T2N1N4
- Recruiting
- University of Calgary
-
Principal Investigator:
- Nicole Culos-Reed, PhD
-
Contact:
- Julianna Dreger
- Phone Number: 403-210-8482
- Email: jdreger@ucalgary.ca
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V6T 1Z7
- Recruiting
- University of British Columbia
-
Contact:
- Carole Yin
- Phone Number: 604-827-1914
- Email: exercise.research@ubc.ca
-
Principal Investigator:
- Kristin Campbell, PhD
-
-
Nova Scotia
-
Halifax, Nova Scotia, Canada, B3H 4R2
- Recruiting
- Nova Scotia Health Authority
-
Contact:
- Tom Christensen
- Phone Number: 902-473-2035
- Email: excancer@nshealth.ca
-
Principal Investigator:
- Melanie Keats, PhD
-
-
Ontario
-
Toronto, Ontario, Canada, M5S 1A1
- Recruiting
- University of Toronto
-
Contact:
- Daniel Sibley
- Phone Number: 403-210-8482
- Email: excel.ontario@utoronto.ca
-
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:
- Alexia Piché
- Phone Number: 5148908000
- Email: alexia.piche.chum@ssss.gouv.qc.ca
-
Principal Investigator:
- Isabelle Doré, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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 |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
All participants will be involved in group exercise classes, twice a week for 8-12 weeks.
|
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
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
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Nicole Culos-Reed, PhD, University of Calgary
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Genital Neoplasms, Male
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Diseases, Male
- Prostatic Diseases
- Male Urogenital Diseases
- Intestinal Diseases
- Respiratory Tract Diseases
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Digestive System Diseases
- Gastrointestinal Diseases
- Colorectal Neoplasms
- Intestinal Neoplasms
- Lung Diseases
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Colonic Diseases
- Skin Diseases
- Breast Diseases
- Behavior
- Skin and Connective Tissue Diseases
- Neoplasms
- Prostatic Neoplasms
- Lung Neoplasms
- Colonic Neoplasms
- Breast Neoplasms
- Motor Activity
Other Study ID Numbers
- HREBA.CC-25-0029
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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