Clinical trial NCT04478851: EXCEL: Exercise for Cancer to Enhance Living Well
Official title: Project EXCEL: Dissemination, Implementation, and Effectiveness of the Exercise Oncology Survivorship Partnership Model - Reaching Rural Cancer Survivors to Enhance Quality of Life
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Head and Neck Cancer
Colon Cancer
Breast Cancer
Prostate Cancer
Cancer Caregivers
Keywords: Physical activity
Exercise
Community programs
Online resources
Quality of life
Cancer survivor
mobile health
telehealth
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: University of Alberta
name: Dalhousie University
name: Alberta Health services
name: University Health Network, Toronto
name: Memorial University of Newfoundland
name: University of British Columbia
name: University of Prince Edward Island
First posted: 2020-07-21
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Hybrid implementation effectiveness study
Primary purpose: SUPPORTIVE_CARE

Brief summary: Project EXCEL will provide community or online exercise programs to rural and remote and under-served cancer survivors, as well as encourage participants to become life-long exercisers. Exercise is an evidence-based self-management strategy that benefits all cancer survivors. However, most cancer survivors who live in remote or rural places don't have adequate opportunities to be involved in exercise programs that are tailored to their needs.

Detailed description: As cancer survivorship numbers grow, a focus on positive health in survivorship is essential. Exercise is an evidence-based effective self-management strategy that benefits all cancer survivors (CS). However, the majority of research and the limited development of evidence-based clinical or community programs in exercise and cancer has been conducted almost exclusively in urban academic and clinical settings, with very limited implementation outreach to "hard to reach" CS.

In this proposed cancer exercise hybrid implementation effectiveness research, over 5 years we will use an integrated knowledge translation approach to move the current evidence-base that clearly supports the role of exercise in cancer survivorship, into sustainable and effective community-based or online settings that will optimize the delivery of exercise to rural/remote and underserved CS (RCS). Implementing and evaluating the proposed Exercise Oncology Survivorship (EOS) partnership model will result in a sustainable resource to support the implementation and delivery of exercise oncology programs in rural Canadian communities.

Investigators will work to develop lasting referral pathways between cancer care clinics and local fitness professionals. These fitness professionals will have additional cancer specific training to ensure they can effectively and safely deliver the program. Eligible and consenting participants will be screened for exercise safety, and following fitness testing will be triaged to appropriate exercise programming. If, due to COVID-19 public health restrictions, community based programming cannot occur, the exercise sessions will be delivered online by fitness professionals.

Eligibility criteria: Inclusion Criteria:

* have a diagnosis of cancer
* are over the age of 18 years
* are able to participate in mild levels of activity
* are about to have treatment, are currently having treatment, or have had cancer treatment within the last 5 years
* can read/write in English
* can access online programs, if necessary, to participate in the exercise programs.

Exclusion Criteria:

* unable to read/write in English
* are unable to participate in exercise
* for online programs, do not have internet or computer access

Primary outcomes:
measure: Physical Activity Minutes Per Week
timeFrame: Baseline to one-year
Secondary outcomes:
measure: Body Composition
timeFrame: Baseline to post 12-week exercise intervention
measure: Aerobic Endurance
timeFrame: Baseline to post 12-week exercise intervention
measure: Upper extremity grip strength
timeFrame: Baseline to post 12-week exercise intervention
measure: Functional performance test
timeFrame: Baseline to post 12-week exercise intervention
measure: Upper extremity flexibility
timeFrame: Baseline to post 12-week exercise intervention
measure: Lower extremity flexibility
timeFrame: Baseline to post 12-week exercise intervention
measure: Balance
timeFrame: Baseline to post 12-week exercise intervention
measure: Symptom tracking
timeFrame: Baseline to one year
measure: Cancer related symptoms
timeFrame: Baseline to one year
measure: Subjective reporting of average weekly physical activity
timeFrame: Baseline to one year
measure: General Health-related Quality of Life
timeFrame: Baseline to one year
measure: Fatigue
timeFrame: Baseline to one year
measure: General well-being
timeFrame: Baseline to one year
measure: Cognition
timeFrame: Baseline to one year
measure: Barriers and facilitators to exercise participation
timeFrame: Baseline to one year
measure: Exercise adherence
timeFrame: Baseline to one year
measure: Program implementation and evaluation
timeFrame: Baseline to one year
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Health and Wellness Lab, University of Calgary
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Halifax
country: Canada
facility: Dalhousie University
state: Nova Scotia
Study officials:
affiliation: University of Calgary
name: Nicole Culos-Reed, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alberta
name: Margaret L McNeely, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dalhousie University
name: Melanie Keats, PhD
role: PRINCIPAL_INVESTIGATOR
References: