NCT04765241

Brief Summary

In this randomized controlled trial the investigators will determine whether a mobile health intervention can increase physical activity levels in AYA cancer survivors over a one year period. The investigators will recruit 320 cancer survivors in Alberta who were diagnosed with a first cancer between the ages of 15 to 39 years and are within one year of treatment completion. Participants will be randomized into either the control group (educational information) or the intervention group (educational information; personalized physical activity plan; activity tracker watch; access to a private, online survivor community; motivational text messages and check-in calls/e-mails). All participants will complete fitness testing and questionnaires at baseline, 6 months and 12 months. A final measurement at 24 months will test long-term effectiveness.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
287

participants targeted

Target at P75+ for not_applicable cancer

Timeline
Completed

Started Sep 2021

Longer than P75 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
active not 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

First Submitted

Initial submission to the registry

February 9, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 21, 2021

Completed
7 months until next milestone

Study Start

First participant enrolled

September 27, 2021

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Completed
Last Updated

January 8, 2026

Status Verified

January 1, 2026

Enrollment Period

4.7 years

First QC Date

February 9, 2021

Last Update Submit

January 6, 2026

Conditions

Cancer

Keywords

Adolescent cancerYoung adult cancerPhysical activitymHealthSurvivorshipAYA cancer

Outcome Measures

Primary Outcomes (1)

  • Changes in weekly minutes of moderate-vigorous intensity physical activity

    Measured by Actigraph

    Baseline, 6 months, 12 months, 24 months

Secondary Outcomes (38)

  • Changes in weekly minutes of sedentary time

    Baseline, 6 months,12 months

  • Changes in weekly minutes of sleep

    Baseline, 6 months,12 months

  • Changes in the Pittsburgh Sleep Quality Index (PSQI) Global Sleep Quality Score

    Baseline, 6 months,12 months

  • Changes in weight

    Baseline, 6 months,12 months

  • Changes in body mass index (BMI)

    Baseline, 6 months,12 months

  • +33 more secondary outcomes

Study Arms (2)

mHealth Physical Activity Intervention

EXPERIMENTAL

The intervention arm will receive a 12 month mobile health (mHealth) physical activity intervention with a goal of increasing their moderate-vigorous intensity physical activity levels by 90 minutes per week above baseline

Behavioral: Physical Activity

Control

NO INTERVENTION

Controls will receive general health education materials

Interventions

Physical ActivityBEHAVIORAL

The intervention includes a physical activity prescription, a Polar activity tracker watch, access to a private AYA cancer survivor community through the Polar Flow community platform, mHealth nudges and surveys via text messaging, and regular phone or email contact from study staff.

mHealth Physical Activity Intervention

Eligibility Criteria

Age15 Years - 39 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Lives in Alberta
  • Diagnosed with invasive malignancy in Alberta
  • Completed active cancer directed therapy (cytotoxic chemotherapy, radiation therapy and/or definitive surgical intervention) in the last 12 months, except for "maintenance" therapy to prevent recurrences
  • Have the ability to read, write and speak English
  • Have access to the Internet on at least a weekly basis
  • Have a mobile phone with a text messaging plan
  • Willing to be randomized to either arm.

You may not qualify if:

  • Health problems which preclude the ability to walk for physical activity, as measured by the Physical Activity Readiness Questionnaire (PAR-Q)
  • Currently pregnant or planning to become pregnant within the next 6 months
  • Currently taking part in \> 300 minutes/week of moderate-to-vigorous intensity physical activity on a regular basis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arthur J.E. Child Comprehensive Cancer Centre

Calgary, Alberta, T2N5G2, Canada

Location

MeSH Terms

Conditions

NeoplasmsMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Christine Friedenreich

    Cancer Care Alberta

    STUDY DIRECTOR

  • Miranda Fidler-Benaoudia

    Cancer Care Alberta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The study team, with the exception of the study coordinator, will be blinded to reduce bias.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2021

First Posted

February 21, 2021

Study Start

September 27, 2021

Primary Completion

June 1, 2026

Study Completion

June 1, 2026

Last Updated

January 8, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)