CancerEXCELNCT04478851
EXCEL: Exercise for Cancer to Enhance Living Well
A study testing Group Exercise Classes in people with Cancer and Head and Neck Cancer, run by University of Calgary at 3 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer, Head and Neck Cancer, Colon Cancer
- What is being tested?
- Group Exercise Classes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 3 sitesCanada
- Study dates
- 2 Sep 2020to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- unable to read/write in English
- are unable to participate in exercise
- for online programs, do not have internet or computer access
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada3 sites, 3 recruiting
- Recruiting
Health and Wellness Lab, University of Calgary
Calgary, Alberta, T2N 1N4
Nicole Culos-Reed, PhD, +1 403-210-8482, wellnesslab@ucalgary.ca
Julianna Dreger, M.ClinExPhys, +1 403-210-8482, wellnesslab@ucalgary.ca
- Not yet recruiting
University of Alberta
Edmonton, Alberta, T6G 2G4
Margaret L McNeely, PhD
- Not yet recruiting
Dalhousie University
Halifax, Nova Scotia, B3H 4R2
Melanie Keats, PhD
About this study
Official title: Project EXCEL: Dissemination, Implementation, and Effectiveness of the Exercise Oncology Survivorship Partnership Model - Reaching Rural Cancer Survivors to Enhance Quality of Life
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.
Read the 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.
- Conditions
- Cancer, Head and Neck Cancer, Colon Cancer, Breast Cancer, Prostate Cancer, Cancer Caregivers
- Being tested
- Group Exercise Classes
- Keywords
- Physical activity, Exercise, Community programs, Online resources, Quality of life, Cancer survivor, mobile health, telehealth
- Medical subject headings
- Neoplasms, Head and Neck Neoplasms, Colonic Neoplasms, Breast Neoplasms, Prostatic Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group Exercise ClassesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | All participants will be involved in group exercise classes, twice a week for 12 weeks. Receives: Behavioral: Group Exercise Classes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to one-year
Secondary outcomes (17)
Body Composition
Change in body mass index (BMI)
Measured: Baseline to post 12-week exercise intervention
Aerobic Endurance
Change in 6-minute walk test (m) or 2 minute step test (steps) results
Measured: Baseline to post 12-week exercise intervention
Upper extremity grip strength
Change in hand-grip dynamometry (kg)
Measured: Baseline to post 12-week exercise intervention
Functional performance test
Change in sit-to-stand (number of repetitions in 30 seconds)
Measured: Baseline to post 12-week exercise intervention
Upper extremity flexibility
Change in active shoulder flexion range of motion (degrees)
Measured: Baseline to post 12-week exercise intervention
Lower extremity flexibility
Change in sit-and-reach test (cm)
Measured: Baseline to post 12-week exercise intervention
Balance
Change in one legged stance test (seconds)
Measured: Baseline to post 12-week exercise intervention
Symptom tracking
Change in fatigue, mood, and QOL, recorded via m-Health app
Measured: Baseline to one year
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.
Measured: Baseline to one year
Subjective reporting of average weekly physical activity
Change in Godin Leisure Time Exercise Questionnaire
Measured: Baseline to one year
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.
Measured: Baseline to one year
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".
Measured: Baseline to one year
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".
Measured: Baseline to one year
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).
Measured: Baseline to one year
Barriers and facilitators to exercise participation
Change in Exercise Barriers and Facilitators questionnaire
Measured: Baseline to one year
Exercise adherence
Adherence to exercise programming (attendance at sessions)
Measured: Baseline to one year
Program implementation and evaluation
RE-AIM: program reach, effectiveness, adoption, implementation and maintenance
Measured: Baseline to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start2 Sep 2020
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Hybrid implementation effectiveness study
- Masking
- None (open label)
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Nicole Culos-Reed, PhD, Principal investigator, University of CalgaryMargaret L McNeely, PhD, Principal investigator, University of AlbertaMelanie Keats, PhD, Principal investigator, Dalhousie University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04478851
- Sponsor's protocol ID
- HREBA.CC-20-0098
- Acronym
- EXCEL
- Status last verified
- Mar 2022
- First submitted
- 15 Jul 2020
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan at this time to share IPD outside of the research team.
Publications
Culos-Reed N, Wagoner CW, Dreger J, McNeely ML, Keats M, Santa Mina D, Cuthbert C, Capozzi LC, Francis GJ, Chen G, Ester M, McLaughlin E, Eisele M, Sibley D, Langley J, Chiekwe J, Christensen T; EXCEL Project Team. Implementing an exercise oncology model to reach rural and remote individuals living with and beyond cancer: a hybrid effectiveness-implementation protocol for project EXCEL (EXercise for Cancer to Enhance Living Well). BMJ Open. 2022 Dec 29;12(12):e063953. doi: 10.1136/bmjopen-2022-063953.
PubMed 36581419
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project EXCEL: Dissemination, Implementation, and Effectiveness of the Exercise Oncology Survivorship Partnership Model - Reaching Rural Cancer Survivors to Enhance Quality of Life
- ClinicalTrials.gov ID
- NCT04478851
- Acronym / sponsor ID
- EXCEL / HREBA.CC-20-0098
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- 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
- Study start
- 2 Sep 2020 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 21 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Hybrid implementation effectiveness study
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Group Exercise ClassesAll participants will be involved in group exercise classes, twice a week for 12 weeks. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- unable to read/write in English
- are unable to participate in exercise
- for online programs, do not have internet or computer access
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group Exercise ClassesThe 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. | Behavioural | Intervention |
Primary outcome
Physical Activity Minutes Per Week
Time frame: Baseline to one-year
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.
17 secondary outcomes
Body Composition
Time frame: Baseline to post 12-week exercise intervention
Aerobic Endurance
Time frame: Baseline to post 12-week exercise intervention
Upper extremity grip strength
Time frame: Baseline to post 12-week exercise intervention
Functional performance test
Time frame: Baseline to post 12-week exercise intervention
Upper extremity flexibility
Time frame: Baseline to post 12-week exercise intervention
Lower extremity flexibility
Time frame: Baseline to post 12-week exercise intervention
Balance
Time frame: Baseline to post 12-week exercise intervention
Symptom tracking
Time frame: Baseline to one year
Cancer related symptoms
Time frame: Baseline to one year
Subjective reporting of average weekly physical activity
Time frame: Baseline to one year
General Health-related Quality of Life
Time frame: Baseline to one year
Fatigue
Time frame: Baseline to one year
General well-being
Time frame: Baseline to one year
Cognition
Time frame: Baseline to one year
Barriers and facilitators to exercise participation
Time frame: Baseline to one year
Exercise adherence
Time frame: Baseline to one year
Program implementation and evaluation
Time frame: Baseline to one year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Derived from this study: PubMed 36581419Culos-Reed N, Wagoner CW, Dreger J, McNeely ML, Keats M, Santa Mina D, Cuthbert C, Capozzi LC, Francis GJ, Chen G, Ester M, McLaughlin E, Eisele M, Sibley D, Langley J, Chiekwe J, Christensen T; EXCEL Project Team. Implementing an exercise oncology model to reach rural and remote individuals living with and beyond cancer: a hybrid effectiveness-implementation protocol for project EXCEL (EXercise for Cancer to Enhance Living Well). BMJ Open. 2022 Dec 29;12(12):e063953. doi: 10.1136/bmjopen-2022-063953.
- Individual participant dataSharing planned: No. No plan at this time to share IPD outside of the research team.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nicole Culos-Reed, PhD principal investigator
University of Calgary
Margaret L McNeely, PhD principal investigator
University of Alberta
Melanie Keats, PhD principal investigator
Dalhousie University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Exercise Classes in people with Cancer and Head and Neck Cancer, run by University of Calgary at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicole Culos-Reed, PhD (+1 (403) 220-7540, nculosre@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Activity Minutes Per Week (time frame: Baseline to one-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04478851, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.