Clinical trial NCT06960291: Sustainable Implementation of the EXCEL Exercise Oncology Program Across Canada
Official title: Sustainable Implementation of the EXCEL Exercise Oncology Program Across Canada
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Prostate Cancers
Breast Cancers
Colon Cancer
Lung Cancers
Keywords: Exercise oncology
Exercise
Physical activity
community program
online exercise
cancer survivor
individual living with and beyond cancer
quality of life
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: University of Alberta
name: Dalhousie University
name: Nova Scotia Health Authority
name: University of Toronto
name: Centre hospitalier de l'Université de Montréal (CHUM)
name: University of British Columbia
name: Memorial University of Newfoundland
name: University of Prince Edward Island
name: Alberta Health services
First posted: 2025-05-07
Enrollment: 740
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Hybrid effectiveness-implementation study
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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'.

Eligibility criteria: 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

Primary outcomes:
measure: Physical Activity Level
timeFrame: Baseline to one year
Secondary outcomes:
measure: Cancer related symptoms
timeFrame: Baseline to one year
measure: Cost-effectiveness
timeFrame: Baseline to one year
measure: Fatigue
timeFrame: Baseline to one year
measure: Quality of life
timeFrame: Baseline to one year
measure: Body Composition
timeFrame: Baseline to 12-weeks
measure: Aerobic Capactiy
timeFrame: Baseline to 12-weeks
measure: Lower body strength
timeFrame: Baseline to 12-weeks
measure: Upper extremity flexibility
timeFrame: Baseline to 12-weeks
measure: Balance
timeFrame: Baseline to 12-weeks
measure: Exercise adherence
timeFrame: Duration of the intervention (8-12 week exercise program)
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
city: Halifax
country: Canada
facility: Nova Scotia Health Authority
state: Nova Scotia
city: Toronto
country: Canada
facility: University of Toronto
state: Ontario
city: Montreal
country: Canada
facility: Centre hospitalier de l'Université de Montréal
state: Quebec
Study officials:
affiliation: University of Calgary
name: Nicole Culos-Reed, PhD
role: PRINCIPAL_INVESTIGATOR
References: