NCT04478851

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for not_applicable cancer

Timeline
20mo left

Started Sep 2020

Longer than P75 for not_applicable cancer

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress78%
Sep 2020Dec 2027

First Submitted

Initial submission to the registry

July 15, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 21, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

September 2, 2020

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

7.3 years

First QC Date

July 15, 2020

Last Update Submit

March 29, 2022

Conditions

Keywords

Physical activityExerciseCommunity programsOnline resourcesQuality of lifeCancer survivormobile healthtelehealth

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline to one-year

Secondary Outcomes (17)

  • Body Composition

    Baseline to post 12-week exercise intervention

  • Aerobic Endurance

    Baseline to post 12-week exercise intervention

  • Upper extremity grip strength

    Baseline to post 12-week exercise intervention

  • Functional performance test

    Baseline to post 12-week exercise intervention

  • Upper extremity flexibility

    Baseline to post 12-week exercise intervention

  • +12 more secondary outcomes

Study Arms (1)

Intervention

EXPERIMENTAL

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

Behavioral: Group Exercise Classes

Interventions

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.

Intervention

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Health and Wellness Lab, University of Calgary

Calgary, Alberta, T2N 1N4, Canada

RECRUITING

University of Alberta

Edmonton, Alberta, T6G 2G4, Canada

NOT YET RECRUITING

Dalhousie University

Halifax, Nova Scotia, B3H 4R2, Canada

NOT YET RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

NeoplasmsHead and Neck NeoplasmsColonic NeoplasmsBreast NeoplasmsProstatic NeoplasmsMotor Activity

Condition Hierarchy (Ancestors)

Neoplasms by SiteColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesBehavior

Study Officials

  • Nicole Culos-Reed, PhD

    University of Calgary

    PRINCIPAL INVESTIGATOR
  • Margaret L McNeely, PhD

    University of Alberta

    PRINCIPAL INVESTIGATOR
  • Melanie Keats, PhD

    Dalhousie University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicole Culos-Reed, PhD

CONTACT

Julianna Dreger, M.ClinExPhys

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Hybrid implementation effectiveness study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2020

First Posted

July 21, 2020

Study Start

September 2, 2020

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

March 31, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

No plan at this time to share IPD outside of the research team.

Locations