EXCEL: Exercise for Cancer to Enhance Living Well (EXCEL)
Primary Purpose
Cancer, Head and Neck Cancer, Colon Cancer
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Group Exercise Classes
Sponsored by
About this trial
This is an interventional supportive care trial for Cancer focused on measuring Physical activity, Exercise, Community programs, Online resources, Quality of life, Cancer survivor, mobile health, telehealth
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
Sites / Locations
- Health and Wellness Lab, University of CalgaryRecruiting
- University of Alberta
- Dalhousie University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention
Arm Description
All participants will be involved in group exercise classes, twice a week for 12 weeks.
Outcomes
Primary Outcome Measures
Physical Activity Minutes Per Week
Change in number of participants meeting Guidelines for Physical Activity of 150 minutes per week of moderate intensity exercise, based on accelerometer data from commercially-available activity tracker.
Secondary Outcome Measures
Body Composition
Change in body mass index (BMI)
Aerobic Endurance
Change in 6-minute walk test (m) or 2 minute step test (steps) results
Upper extremity grip strength
Change in hand-grip dynamometry (kg)
Functional performance test
Change in sit-to-stand (number of repetitions in 30 seconds)
Upper extremity flexibility
Change in active shoulder flexion range of motion (degrees)
Lower extremity flexibility
Change in sit-and-reach test (cm)
Balance
Change in one legged stance test (seconds)
Symptom tracking
Change in fatigue, mood, and QOL, recorded via m-Health app
Cancer related symptoms
Change in Edmonton Symptom Assessment Scale.
- 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.
Subjective reporting of average weekly physical activity
Change in Godin Leisure Time Exercise Questionnaire
General Health-related Quality of Life
Change in EuroQual - 5Dimensions (EQ-5D) tool
- first section is a questionniare; last section uses a scale from 0-100, where 0 means the worst health imaginable and 100 means the best health imaginable.
Fatigue
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".
General well-being
Change in Functional Assessment of Cancer Therapy - General subscale
- scale is from 0-4, where 0 means "not at all" and 4 means "very much".
Cognition
Change in Functional Assessment of Cancer Therapy - Cognitive subscale
- scale is from 0-4, where 0 means "never" and 4 means "several times a day" (experiencing symptoms).
Barriers and facilitators to exercise participation
Change in Exercise Barriers and Facilitators questionnaire
Exercise adherence
Adherence to exercise programming (attendance at sessions)
Program implementation and evaluation
RE-AIM: program reach, effectiveness, adoption, implementation and maintenance
Full Information
NCT ID
NCT04478851
First Posted
July 15, 2020
Last Updated
March 29, 2022
Sponsor
University of Calgary
Collaborators
University of Alberta, Dalhousie University, Alberta Health services, University Health Network, Toronto, Memorial University of Newfoundland, University of British Columbia, University of Prince Edward Island
1. Study Identification
Unique Protocol Identification Number
NCT04478851
Brief Title
EXCEL: Exercise for Cancer to Enhance Living Well
Acronym
EXCEL
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
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 2, 2020 (Actual)
Primary Completion Date
December 31, 2027 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Calgary
Collaborators
University of Alberta, Dalhousie University, Alberta Health services, University Health Network, Toronto, Memorial University of Newfoundland, University of British Columbia, University of Prince Edward Island
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Hybrid implementation effectiveness study
Masking
None (Open Label)
Allocation
N/A
Enrollment
1500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
All participants will be involved in group exercise classes, twice a week for 12 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Group Exercise Classes
Intervention Description
The exercise program to be implemented for rural cancer survivors will combine aerobic, resistance, balance, and flexibility exercises delivered in a circuit-type class setting or group personal training format, twice weekly for a 12-week period. If public health restrictions require closure of fitness facilities due to COVID-19, the program will be delivered online. If facilities are open, the sessions will be integrated in the community, delivered in-person. Whether delivered in-class or remotely, the program follows exercise progression principles (ie, frequency, intensity, time, type, overload and progression) over the 12-weeks, with tailoring of any exercise to meet individual participant needs as required, in order to promote fitness and wellness benefits. The exercise intervention is based on the Alberta Cancer Exercise (ACE) program.
Primary Outcome Measure Information:
Title
Physical Activity Minutes Per Week
Description
Change in number of participants meeting Guidelines for Physical Activity of 150 minutes per week of moderate intensity exercise, based on accelerometer data from commercially-available activity tracker.
Time Frame
Baseline to one-year
Secondary Outcome Measure Information:
Title
Body Composition
Description
Change in body mass index (BMI)
Time Frame
Baseline to post 12-week exercise intervention
Title
Aerobic Endurance
Description
Change in 6-minute walk test (m) or 2 minute step test (steps) results
Time Frame
Baseline to post 12-week exercise intervention
Title
Upper extremity grip strength
Description
Change in hand-grip dynamometry (kg)
Time Frame
Baseline to post 12-week exercise intervention
Title
Functional performance test
Description
Change in sit-to-stand (number of repetitions in 30 seconds)
Time Frame
Baseline to post 12-week exercise intervention
Title
Upper extremity flexibility
Description
Change in active shoulder flexion range of motion (degrees)
Time Frame
Baseline to post 12-week exercise intervention
Title
Lower extremity flexibility
Description
Change in sit-and-reach test (cm)
Time Frame
Baseline to post 12-week exercise intervention
Title
Balance
Description
Change in one legged stance test (seconds)
Time Frame
Baseline to post 12-week exercise intervention
Title
Symptom tracking
Description
Change in fatigue, mood, and QOL, recorded via m-Health app
Time Frame
Baseline to one year
Title
Cancer related symptoms
Description
Change in Edmonton Symptom Assessment Scale.
- 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.
Time Frame
Baseline to one year
Title
Subjective reporting of average weekly physical activity
Description
Change in Godin Leisure Time Exercise Questionnaire
Time Frame
Baseline to one year
Title
General Health-related Quality of Life
Description
Change in EuroQual - 5Dimensions (EQ-5D) tool
- first section is a questionniare; last section uses a scale from 0-100, where 0 means the worst health imaginable and 100 means the best health imaginable.
Time Frame
Baseline to one year
Title
Fatigue
Description
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".
Time Frame
Baseline to one year
Title
General well-being
Description
Change in Functional Assessment of Cancer Therapy - General subscale
- scale is from 0-4, where 0 means "not at all" and 4 means "very much".
Time Frame
Baseline to one year
Title
Cognition
Description
Change in Functional Assessment of Cancer Therapy - Cognitive subscale
- scale is from 0-4, where 0 means "never" and 4 means "several times a day" (experiencing symptoms).
Time Frame
Baseline to one year
Title
Barriers and facilitators to exercise participation
Description
Change in Exercise Barriers and Facilitators questionnaire
Time Frame
Baseline to one year
Title
Exercise adherence
Description
Adherence to exercise programming (attendance at sessions)
Time Frame
Baseline to one year
Title
Program implementation and evaluation
Description
RE-AIM: program reach, effectiveness, adoption, implementation and maintenance
Time Frame
Baseline to one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicole Culos-Reed, PhD
Phone
+1 (403) 220-7540
Email
nculosre@ucalgary.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Julianna Dreger, M.ClinExPhys
Phone
+1 (403) 210-8482
Email
jdreger@ucalgary.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicole Culos-Reed, PhD
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Margaret L McNeely, PhD
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Melanie Keats, PhD
Organizational Affiliation
Dalhousie University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Health and Wellness Lab, University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 1N4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicole Culos-Reed, PhD
Phone
+1 403-210-8482
Email
wellnesslab@ucalgary.ca
First Name & Middle Initial & Last Name & Degree
Julianna Dreger, M.ClinExPhys
Phone
+1 403-210-8482
Email
wellnesslab@ucalgary.ca
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2G4
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margaret L McNeely, PhD
Facility Name
Dalhousie University
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 4R2
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melanie Keats, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No plan at this time to share IPD outside of the research team.
Learn more about this trial
EXCEL: Exercise for Cancer to Enhance Living Well
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