Recruiting

EXCEL Program

Sponsor:

University of Calgary

Code:

NCT04790578

Conditions

Cancer

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

ZoeInsights Application

EXCEL Exercise Class

Study Details

Brief summary:

Exercise adherence and maintenance in the EXCEL program supported with a smart phone application: A pilot randomized controlled trial

Conditions

Cancer

Study ID

NCT04790578

Start date

Apr 1, 2021

Status verified date

Mar, 2022

Completion date

Jun 30, 2023

Anticipated

Primary completion date

Dec 30, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Inclusion Criteria

  • Have a cancer diagnosis
  • Be over the age of 18 years
  • Be able to participate in mild levels of activity as a minimum (to be assessed during screening via the Physical Activity Readiness Questionnaire)
  • Be pre-treatment, or receiving active cancer treatment, or have received cancer treatment within the past three year
  • Be able to provide informed written consent in English
  • Have access to internet service that can support video calling
  • Be signed up for the EXCEL baseline class

Exclusion Criteria:

-

Study Design

Enrollment

140 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: ZoeInsights Application Arm

Participants will receive free access to the ZI app for the 12-week intervention. After completing initial set-up, participants will be asked to record physical activity and symptoms regularly via scheduled in-app routines. Further use of ZI (eg. Custom daily routines, additional graphing, medication tracking, accessing linked health resources) during the intervention will be possible ad libitum. After the initial 12-weeks of the EXCEL+ZI intervention, participants have continued free access to the ZI app for up to 1 year.

active comparator: Waitlist control

During the 12-week intervention the participants will only take part in an online delivered EXCEL exercise class and will not have access to the ZI app. After completion of the 24-week test, the participants will be granted access to the ZI app.

Interventions

ZoeInsights Application

ZI is designed to promote PA behavior change and maintenance via self-monitoring of PA, symptoms, and other health data. Additional information for using ZI will be provided via a PDF-based user guide on installing and using the application, a live instructional webinar hosted by ZI developer Hanalytics Solutions, and access to continued support via email/telephone communication with study staff as well as Hanalytics Solutions. Reminders to complete self-monitoring tasks will be provided using daily push notifications scheduled according to participant preferences. Automatic graphs will be generated and displayed within the app to allow participants to visualize trends in physical activity, symptoms, and other health data. ZI can be accessed via a web browser on any device that is connected to the internet (e.g. computer, laptop, tablet, smartphone), or via a native android or iOS mobile application on a smartphone or tablet.

EXCEL Exercise Class

The group based remote exercise program is delivered twice a week over the Zoom application. Classes are one hour long with a ten minute warm up, 40 minute strength and conditioning focused exercise circuits, and a ten minute stretching. Each class is followed by additional time to provide participants with an opportunity to interact with each other, fostering social support.

Primary outcome measure

  • Objective Physical Activity Minutes Per Week [ Time Frame: Measured continuously from baseline to 24 weeks ]
  • Subjective Physical Activity Minutes Per Week [ Time Frame: Self-reported at baseline, week 4, week 12, and week 24 ]
  • EXCEL class attendance [ Time Frame: Potential class data in EXCEL baseline and maintenance classes will be recorded, and input into REDCap, from week 1-12 (baseline); and 12-24 (maintenance, optional) ]

Central Contacts and Locations

Central contacts

Manuel Ester

+17788144605manuel.ester@ucalgary.ca

Locations

University of Calgary

Recruiting

Calgary, Alberta, Canada, T2N 1N4

Contacts

Julianna Dreger

4032108482

More Information

Sponsor

University of Calgary

Last update posted

Apr 7, 2022

Last verified

Mar, 2022

Keywords

  • Exercise
  • mHealth

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Calgary on 2022-04-07.