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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
287
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.
Arthur J.E. Child Comprehensive Cancer Centre
Calgary, Alberta, Canada
Changes in weekly minutes of moderate-vigorous intensity physical activity
Measured by Actigraph
Time frame: Baseline, 6 months, 12 months, 24 months
Changes in weekly minutes of sedentary time
Measured by Actigraph
Time frame: Baseline, 6 months,12 months
Changes in weekly minutes of sleep
Measured by Actigraph
Time frame: 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
Time frame: Baseline, 6 months,12 months
Changes in weight
Measured in kilograms
Time frame: Baseline, 6 months,12 months
Changes in body mass index (BMI)
Measured by combining height (meters) and weight (kilograms) and reported in kg/m2
Time frame: Baseline, 6 months,12 months
Changes in waist and hip circumference
Measured in centimeters
Time frame: 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
Time frame: 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
Time frame: Baseline, 6 months,12 months
Changes in grip strength
Measured in kilograms using a hand dynamometer
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline, 6 months,12 months
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