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CancerAYA-PACTNCT04765241

mHealth Physical Activity Intervention for Young Cancer Survivors

A study testing Physical Activity in people with Cancer, run by AHS Cancer Control Alberta at 1 site in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 15 to 39 years
Conditions the study is for
Cancer
What is being tested?
Physical Activity
Could I receive a placebo?
No, everyone receives an active treatment
How many people
287 participants
Where
1 siteCanada
Study dates
27 Sep 2021to May 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 15 to 39 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Arthur J.E. Child Comprehensive Cancer Centre

    Calgary, Alberta, T2N5G2

Other trials in Canada

About this study

Official title: Adolescents and Young Adults Becoming Physically Active After Cancer Trial

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.

Read the detailed description

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.

Conditions
Cancer
Being tested
Physical Activity
Keywords
Adolescent cancer, Young adult cancer, Physical activity, mHealth, Survivorship, AYA cancer
Medical subject headings
Neoplasms, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physical ActivityBehavioural

    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.

Study groups in NCT04765241
Study groupRoleWhat they receive
mHealth Physical Activity InterventionExperimentalThe 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.
Receives: Behavioral: Physical Activity
ControlNo interventionControls received "standard of care" from their medical team and were not provided with any physical activity guidance.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured by ActiGraph

    Measured: Baseline to 12 months

Secondary outcomes (43)

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

    Measured by ActiGraph

    Measured: Baseline to 6 months and 24 months.

  2. Changes in weekly minutes of sleep

    Measured by ActiGraph

    Measured: Baseline, 6 months, 12 months, 24 months

  3. Changes in weekly minutes of sedentary time

    Measured by ActiGraph

    Measured: Baseline, 6 months,12 months, 24 months

  4. Changes in moderate-vigorous physical activity using the self-administered Past Year Total Physical Activity Questionnaire (PYTPAQ).

    Met-Hours per week and hours per week of moderate-vigorous physical activity

    Measured: Baseline, 12 months, 24 months.

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

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

    Measured: Baseline, 6 months,12 months

  6. Changes in weight

    Measured in kilograms

    Measured: Baseline, 6 months,12 months

  7. Changes in body mass index (BMI)

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

    Measured: Baseline, 6 months,12 months

  8. Changes in waist and hip circumference

    Measured in centimeters

    Measured: Baseline, 6 months,12 months

  9. Changes in cardiorespiratory fitness

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

    Measured: Baseline, 6 months,12 months

  10. Changes in cardiorespiratory fitness

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

    Measured: Baseline, 6 months,12 months

  11. Changes in grip strength

    Measured in kilograms using a hand dynamometer

    Measured: Baseline, 6 months,12 months

  12. Changes in upper body muscular strength

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

    Measured: Baseline, 6 months,12 months

  13. Changes in upper body muscular endurance

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

    Measured: Baseline, 6 months,12 months

  14. Changes in lower body muscular strength

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

    Measured: Baseline, 6 months,12 months

  15. Changes in lower body muscular endurance

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

    Measured: Baseline, 6 months,12 months

  16. Changes in frailty

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

    Measured: Baseline, 6 months,12 months

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

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

    Measured: Baseline, 6 months,12 months

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

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

    Measured: Baseline, 6 months,12 months

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

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

    Measured: Baseline, 6 months,12 months

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

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

    Measured: Baseline, 6 months,12 months

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

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

    Measured: Baseline, 6 months,12 months

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

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

    Measured: Baseline, 6 months,12 months

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

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

    Measured: Baseline, 6 months,12 months

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

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

    Measured: Baseline, 6 months,12 months

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

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

    Measured: Baseline, 6 months,12 months

  26. Changes in the Short Form 36 Mental Health subscale

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

    Measured: Baseline, 6 months,12 months

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

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

    Measured: Baseline, 6 months,12 months

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

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

    Measured: Baseline, 6 months,12 months

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

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

    Measured: Baseline, 6 months,12 months

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

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

    Measured: Baseline, 6 months,12 months

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

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

    Measured: Baseline, 6 months,12 months

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

    Score range is from 0 to 72. Higher scores indicate better quality of life.

    Measured: Baseline, 6 months,12 months

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

    Score range is from 0 to 16 where higher scores indicate better quality of life.

    Measured: Baseline, 6 months,12 months

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

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

    Measured: Baseline, 6 months,12 months

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

    Score range is from 0 to 16 where higher scores indicate better quality of life.

    Measured: Baseline, 6 months,12 months

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

    Score range is from 0 to 52 where higher scores indicate better quality of life.

    Measured: Baseline, 6 months,12 months

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

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

    Measured: Baseline, 6 months,12 months

  38. Changes in fear of cancer recurrence - short form (FCRI-SF)

    Score range is from 0 - 36 where higher scores indicate greater fear of recurrence severity.

    Measured: Baseline, 6 months, 12 months

  39. Changes in Sedentary Behaviour using a 7 day Sedentary Recall

    Hours of sitting during the week and on weekends for the following categories: (1) traveling to work, (2) at work or school, (3) watching television, (4) using a computer, and (5) leisure time not including television.

    Measured: Baseline, 6 months, 12 months.

  40. Changes in environmental barriers that prevent or limit walking and cycling where a person lives or works - PANES Questionnaire

    Score range is from 1 to 4 with higher values indicating greater environmental support for physical activity.

    Measured: Baseline, 6 months, 12 months.

  41. Changes in Exercise Self-Efficacy - Subscale (FITNET Questionnaire)

    Range of scores from 11 to 55 with higher scores indicated higher self-efficacy.

    Measured: Baseline, 6 months, 12 months

  42. Changes in Social Support from Family and Friends related to Exercise - Subscale (FITNET Questionnaire)

    Range of scores from 10 to 50 with higher scores indicating more support.

    Measured: Baseline, 6 months, 12 months.

  43. Changes in Self-Monitoring related to setting exercise goals and planning exercise activities - Subscale (FITNET Questionnaire)

    Range of scores from 12 to 60 with higher scores indicating more self-monitoring.

    Measured: Baseline, 6 months, 12 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2021
  2. Study start27 Sep 2021
  3. Primary completion16 Jul 2026
  4. Study completionMay 2027 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
287 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04765241
Sponsor's protocol ID
HREBA.CC-20-0397
Acronym
AYA-PACT
Status last verified
Sep 2026
First submitted
9 Feb 2021
Last updated
25 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Physical Activity in people with Cancer, run by AHS Cancer Control Alberta at 1 site 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 7 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: under way, not looking for participants, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in weekly minutes of moderate-vigorous intensity physical activity (time frame: Baseline to 12 months). 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 NCT04765241.

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 25 Sep 2026.

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AYA-PACT Clinical Trial NCT04765241 | AzTrials