mHealth Physical Activity Intervention for Young Cancer Survivors

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Adolescents and Young Adults Becoming Physically Active After Cancer Trial

Conditions
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Cancer

Intervention / Treatment
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* Behavioral: Physical Activity


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mHealth Physical Activity Intervention<br>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<br>* 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.<br>|
| No Intervention: Control<br>Controls will receive general health education materials | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in weekly minutes of moderate-vigorous intensity physical activity | Measured by Actigraph | Baseline, 6 months, 12 months, 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in weekly minutes of sedentary time | Measured by Actigraph | Baseline, 6 months,12 months | 
| Changes in weekly minutes of sleep | Measured by Actigraph | Baseline, 6 months,12 months | 
| 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 | Baseline, 6 months,12 months | 
| Changes in weight | Measured in kilograms | Baseline, 6 months,12 months | 
| Changes in body mass index (BMI) | Measured by combining height (meters) and weight (kilograms) and reported in kg/m2 | Baseline, 6 months,12 months | 
| Changes in waist and hip circumference | Measured in centimeters | Baseline, 6 months,12 months | 
| Changes in cardiorespiratory fitness | 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 | Baseline, 6 months,12 months | 
| Changes in cardiorespiratory fitness | 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 | Baseline, 6 months,12 months | 
| Changes in grip strength | Measured in kilograms using a hand dynamometer | Baseline, 6 months,12 months | 
| Changes in upper body muscular strength | Measured in kilograms using an 8-10 repetition maximum (RM) chest press test used to predict 1-RM | Baseline, 6 months,12 months | 
| Changes in upper body muscular endurance | Measured in kilograms using the maximum number of chest press repetitions completed at 50-70% of estimated 1-RM | Baseline, 6 months,12 months | 
| Changes in lower body muscular strength | Measured in kilograms using an 8-10 repetition maximum (RM) leg press test used to predict 1-RM | Baseline, 6 months,12 months | 
| Changes in lower body muscular endurance | Measured in kilograms using the maximum number of leg press repetitions completed at 50-70% of estimated 1-RM | Baseline, 6 months,12 months | 
| 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 | Baseline, 6 months,12 months | 
| 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 | Baseline, 6 months,12 months | 
| 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 | Baseline, 6 months,12 months | 
| Changes in the Short Form 36 (SF-36) Physical Functioning subscale | Score range is from 0 to 100 where higher scores indicate higher functioning | Baseline, 6 months,12 months | 
| Changes in the Short Form 36 (SF-36) Role-physical subscale | Score range is from 0 to 100 where higher scores indicate higher functioning | Baseline, 6 months,12 months | 
| Changes in the Short Form 36 (SF-36) Bodily Pain subscale | Score range is from 0 to 100 where higher scores indicate less pain | Baseline, 6 months,12 months | 
| Changes in the Short Form 36 (SF-36) General Health subscale | Score range is from 0 to 100 where higher scores indicate better health | Baseline, 6 months,12 months | 
| Changes in the Short Form 36 (SF-36) Vitality subscale | Score range is from 0 to 100 where higher scores indicate higher vitality | Baseline, 6 months,12 months | 
| Changes in the Short Form 36 (SF-36) Social Functioning subscale | Score range is from 0 to 100 where higher scores indicate higher functioning | Baseline, 6 months,12 months | 
| Changes in the Short Form 36 (SF-36) Role-emotional subscale | Score range is from 0 to 100 where higher scores indicate higher functioning | Baseline, 6 months,12 months | 
| Changes in the Short Form 36 Mental Health subscale | Score range is from 0 to 100 where higher scores indicate better mental health | Baseline, 6 months,12 months | 
| Changes in the Cancer Distress Scales for AYAs Impact of Cancer subscale | Scores range from 0 to 100 where higher scores indicate more distress | Baseline, 6 months,12 months | 
| Changes in the Cancer Distress Scales for AYAs Physical subscale | Scores range from 0 to 100 where higher scores indicate more distress | Baseline, 6 months,12 months | 
| Changes in the Cancer Distress Scales for AYAs Emotional subscale | Scores range from 0 to 100 where higher scores indicate more distress | Baseline, 6 months,12 months | 
| Changes in the Cancer Distress Scales for AYAs Cognitive subscale | Scores range from 0 to 100 where higher scores indicate more distress | Baseline, 6 months,12 months | 
| Changes in the Cancer Distress Scales for AYAs Cancer Worry subscale | Scores range from 0 to 100 where higher scores indicate more distress | Baseline, 6 months,12 months | 
| Changes in the Cancer Distress Scales for AYAs Employment subscale | Scores range from 0 to 100 where higher scores indicate more distress | Baseline, 6 months,12 months | 
| Changes in the Cancer Distress Scales for AYAs Education subscale | Scores range from 0 to 100 where higher scores indicate more distress | Baseline, 6 months,12 months | 
| Changes in the Cancer Distress Scales for AYAs Practical subscale | Scores range from 0 to 100 where higher scores indicate more distress | Baseline, 6 months,12 months | 
| Changes in the Functional Assessment of Cancer Therapy Cognitive Function Perceived Cognitive Impairment subscale | Score range is from 0 to 80. Higher scores indicate poorer quality of life. | Baseline, 6 months,12 months | 
| 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 poorer cognition | Baseline, 6 months,12 months | 
| 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 | Baseline, 6 months,12 months | 
| 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 poorer cognition | Baseline, 6 months,12 months | 
| Changes in the Functional Assessment of Cancer Therapy Fatigue (FACT-F) | Score range is from 0 to 52 where higher scores indicate less fatigue | Baseline, 6 months,12 months | 
| Changes in the Comprehensive Score for Financial Toxicity (COST) | Score range is from 0 to 44 where higher scores indicate better financial wellbeing | Baseline, 6 months,12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adolescent cancer, Young adult cancer, Physical activity, mHealth, Survivorship, AYA cancer