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Clinical Trials/NCT06960291
NCT06960291RecruitingNot Applicable

Sustainable Implementation of the EXCEL Exercise Oncology Program Across Canada

University of Calgary10 sites in 1 country740 target enrollmentStarted: March 11, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
740
Locations
10
Primary Endpoint
Physical Activity Level

Study Overview

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'.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Intervention

Experimental

All participants will be involved in group exercise classes, twice a week for 8-12 weeks.

Intervention: Group Exercise Classes (Behavioral)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Cost-effectiveness(Baseline to one year)
  • Fatigue(Baseline to one year)
  • Quality of life(Baseline to one year)
  • Body Composition(Baseline to 12-weeks)
  • Aerobic Capactiy(Baseline to 12-weeks)
  • Lower body strength(Baseline to 12-weeks)
  • Upper extremity flexibility(Baseline to 12-weeks)
  • Balance(Baseline to 12-weeks)
  • Exercise adherence(Duration of the intervention (8-12 week exercise program))
  • Cancer related symptoms(Baseline to one year)
  • Cancer related symptoms(Baseline to one year)
  • Cost-effectiveness(Baseline to one year)
  • Fatigue(Baseline to one year)
  • Quality of life(Baseline to one year)
  • Body Composition(Baseline to 12-weeks)
  • Aerobic Capactiy(Baseline to 12-weeks)
  • Lower body strength(Baseline to 12-weeks)
  • Upper extremity flexibility(Baseline to 12-weeks)
  • Balance(Baseline to 12-weeks)
  • Exercise adherence(Duration of the intervention (8-12 week exercise program))
  • Program implementation and evaluation(Baseline to one year)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (10)

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