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NCT Number: NCT04765241

mHealth Physical Activity Intervention for Young Cancer Survivors

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Cancer Behavior Motor Activity Neoplasms

Age range

15 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arthur J.E. Child Comprehensive Cancer Centre

Calgary, Alberta, T2N5G2, Canada

About this study

Background:

There is a need for adolescent and young adult (AYA) cancer research because the number of new cancers in young people is increasing and the survivor population is growing. Interventions that try to reduce problems that affect people after cancer are particularly important since its treatments can have negative effects on survivors' physical and mental health even decades after diagnosis.

Aim:

Given the many positive effects of physical activity (e.g. improved fitness and quality of life), the study aims to encourage AYA cancer survivors to be more physically active as they shift from treatment to survivorship care. The main goal of this study is to see if a home-based, mobile health (mHealth) physical activity intervention can increase physical activity levels by at least 90 minutes/week compared to baseline in AYA cancer survivors.

Methods:

The investigators will conduct a two-center randomized controlled trial of 320 AYA cancer survivors. Participants (N=320) will be Albertan residents, diagnosed with a first cancer between the ages of 15 and 39 years, and within one year of cancer treatment completion. At the start of the study, participants will complete fitness testing and questionnaires. Participants will then be randomly put into either a control or intervention group. The control group will receive educational information only. The intervention group will also receive a personalized physical activity plan, an activity tracker watch, access to a private, online survivor community, motivational text messages and check-in calls/e-mails. Fitness testing and questionnaires will be repeated at 6 and 12 months to see if the intervention increased physical activity levels and improved health outcomes among the participants in the intervention group compared to controls. A final measurement at 24 months will test long-term use.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Physical activity

Behavioral

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.

Primary outcomes

  1. Changes in weekly minutes of moderate-vigorous intensity physical activity

    Time frame: Baseline, 6 months, 12 months, 24 months

    Measured by Actigraph

Secondary outcomes

  1. Changes in weekly minutes of sedentary time

    Time frame: Baseline, 6 months,12 months

    Measured by Actigraph

  2. Changes in weekly minutes of sleep

    Time frame: Baseline, 6 months,12 months

    Measured by Actigraph

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

    Time frame: Baseline, 6 months,12 months

    Global score range is 0 to 23 where higher scores indicate worse sleep quality

  4. Changes in weight

    Time frame: Baseline, 6 months,12 months

    Measured in kilograms

  5. Changes in body mass index (BMI)

    Time frame: Baseline, 6 months,12 months

    Measured by combining height (meters) and weight (kilograms) and reported in kg/m2

  6. Changes in waist and hip circumference

    Time frame: Baseline, 6 months,12 months

    Measured in centimeters

  7. Changes in cardiorespiratory fitness

    Time frame: Baseline, 6 months,12 months

    Measured by peak oxygen consumption in relative (ml/kg/min) values using the incremental Balke and Ware treadmill test with direct measures of gas exchange and ventilation

  8. Changes in cardiorespiratory fitness

    Time frame: Baseline, 6 months,12 months

    Measured by peak oxygen consumption in absolute (L/min) values using the incremental Balke and Ware treadmill test with direct measures of gas exchange and ventilation

  9. Changes in grip strength

    Time frame: Baseline, 6 months,12 months

    Measured in kilograms using a hand dynamometer

  10. Changes in upper body muscular strength

    Time frame: Baseline, 6 months,12 months

    Measured in kilograms using an 8-10 repetition maximum (RM) chest press test used to predict 1-RM

  11. Changes in upper body muscular endurance

    Time frame: Baseline, 6 months,12 months

    Measured in kilograms using the maximum number of chest press repetitions completed at 50-70% of estimated 1-RM

  12. Changes in lower body muscular strength

    Time frame: Baseline, 6 months,12 months

    Measured in kilograms using an 8-10 repetition maximum (RM) leg press test used to predict 1-RM

  13. Changes in lower body muscular endurance

    Time frame: Baseline, 6 months,12 months

    Measured in kilograms using the maximum number of leg press repetitions completed at 50-70% of estimated 1-RM

  14. Changes in frailty

    Time frame: Baseline, 6 months,12 months

    Defined according to the Fried phenotype which takes into account low lean muscle mass, exhaustion, low energy expenditure, walking limitations, and weakness

  15. Changes in the Short Form 36 (SF-36) Mental Health Component subscale

    Time frame: Baseline, 6 months,12 months

    Score range is from 0 to 100 where higher scores indicate better mental health

  16. Changes in the Short Form 36 (SF-36) Physical Health Component subscale

    Time frame: Baseline, 6 months,12 months

    Score range is from 0 to 100 where higher scores indicate better physical health

  17. Changes in the Short Form 36 (SF-36) Physical Functioning subscale

    Time frame: Baseline, 6 months,12 months

    Score range is from 0 to 100 where higher scores indicate higher functioning

  18. Changes in the Short Form 36 (SF-36) Role-physical subscale

    Time frame: Baseline, 6 months,12 months

    Score range is from 0 to 100 where higher scores indicate higher functioning

  19. Changes in the Short Form 36 (SF-36) Bodily Pain subscale

    Time frame: Baseline, 6 months,12 months

    Score range is from 0 to 100 where higher scores indicate less pain

  20. Changes in the Short Form 36 (SF-36) General Health subscale

    Time frame: Baseline, 6 months,12 months

    Score range is from 0 to 100 where higher scores indicate better health

  21. Changes in the Short Form 36 (SF-36) Vitality subscale

    Time frame: Baseline, 6 months,12 months

    Score range is from 0 to 100 where higher scores indicate higher vitality

  22. Changes in the Short Form 36 (SF-36) Social Functioning subscale

    Time frame: Baseline, 6 months,12 months

    Score range is from 0 to 100 where higher scores indicate higher functioning

  23. Changes in the Short Form 36 (SF-36) Role-emotional subscale

    Time frame: Baseline, 6 months,12 months

    Score range is from 0 to 100 where higher scores indicate higher functioning

  24. Changes in the Short Form 36 Mental Health subscale

    Time frame: Baseline, 6 months,12 months

    Score range is from 0 to 100 where higher scores indicate better mental health

  25. Changes in the Cancer Distress Scales for AYAs Impact of Cancer subscale

    Time frame: Baseline, 6 months,12 months

    Scores range from 0 to 100 where higher scores indicate more distress

  26. Changes in the Cancer Distress Scales for AYAs Physical subscale

    Time frame: Baseline, 6 months,12 months

    Scores range from 0 to 100 where higher scores indicate more distress

  27. Changes in the Cancer Distress Scales for AYAs Emotional subscale

    Time frame: Baseline, 6 months,12 months

    Scores range from 0 to 100 where higher scores indicate more distress

  28. Changes in the Cancer Distress Scales for AYAs Cognitive subscale

    Time frame: Baseline, 6 months,12 months

    Scores range from 0 to 100 where higher scores indicate more distress

  29. Changes in the Cancer Distress Scales for AYAs Cancer Worry subscale

    Time frame: Baseline, 6 months,12 months

    Scores range from 0 to 100 where higher scores indicate more distress

  30. Changes in the Cancer Distress Scales for AYAs Employment subscale

    Time frame: Baseline, 6 months,12 months

    Scores range from 0 to 100 where higher scores indicate more distress

  31. Changes in the Cancer Distress Scales for AYAs Education subscale

    Time frame: Baseline, 6 months,12 months

    Scores range from 0 to 100 where higher scores indicate more distress

  32. Changes in the Cancer Distress Scales for AYAs Practical subscale

    Time frame: Baseline, 6 months,12 months

    Scores range from 0 to 100 where higher scores indicate more distress

  33. Changes in the Functional Assessment of Cancer Therapy Cognitive Function Perceived Cognitive Impairment subscale

    Time frame: Baseline, 6 months,12 months

    Score range is from 0 to 80. Higher scores indicate poorer quality of life.

  34. Changes in the Functional Assessment of Cancer Therapy Cognitive Function (FACT-Cog) Comments From Others subscale

    Time frame: Baseline, 6 months,12 months

    Score range is from 0 to 16 where higher scores indicate poorer cognition

  35. Changes in the Functional Assessment of Cancer Therapy Cognitive Function (FACT-Cog) Perceived Cognitive Abilities subscale

    Time frame: Baseline, 6 months,12 months

    Score range is from 0 to 36 where higher scores indicate poorer cognition

  36. Changes in the Functional Assessment of Cancer Therapy Cognitive Function (FACT-Cog) Impact on Quality of Life subscale

    Time frame: Baseline, 6 months,12 months

    Score range is from 0 to 16 where higher scores indicate poorer cognition

  37. Changes in the Functional Assessment of Cancer Therapy Fatigue (FACT-F)

    Time frame: Baseline, 6 months,12 months

    Score range is from 0 to 52 where higher scores indicate less fatigue

  38. Changes in the Comprehensive Score for Financial Toxicity (COST)

    Time frame: Baseline, 6 months,12 months

    Score range is from 0 to 44 where higher scores indicate better financial wellbeing

Sponsors and collaborators

Lead sponsor

AHS Cancer Control Alberta

Other

Collaborators

  • University of Calgary

Registry information

Official study title

Adolescents and Young Adults Becoming Physically Active After Cancer Trial

Acronym: AYA-PACT

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Feb 21, 2021
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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