mHealth Physical Activity Intervention for Young Cancer Survivors
- Conditions
- Cancer
- Interventions
- Behavioral: Physical Activity
- Registration Number
- NCT04765241
- Lead Sponsor
- AHS Cancer Control Alberta
- 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.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 287
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description mHealth Physical Activity Intervention Physical Activity 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
- Primary Outcome Measures
Name Time Method Changes in weekly minutes of moderate-vigorous intensity physical activity Baseline, 6 months, 12 months, 24 months Measured by Actigraph
- Secondary Outcome Measures
Name Time Method Changes in upper body muscular endurance Baseline, 6 months,12 months Measured in kilograms using the maximum number of chest press repetitions completed at 50-70% of estimated 1-RM
Changes in lower body muscular endurance Baseline, 6 months,12 months Measured in kilograms using the maximum number of leg press repetitions completed at 50-70% of estimated 1-RM
Changes in the Short Form 36 (SF-36) Mental Health Component subscale Baseline, 6 months,12 months Score range is from 0 to 100 where higher scores indicate better mental health
Changes in weekly minutes of sedentary time Baseline, 6 months,12 months Measured by Actigraph
Changes in the Pittsburgh Sleep Quality Index (PSQI) Global Sleep Quality Score Baseline, 6 months,12 months Global score range is 0 to 23 where higher scores indicate worse sleep quality
Changes in upper body muscular strength Baseline, 6 months,12 months Measured in kilograms using an 8-10 repetition maximum (RM) chest press test used to predict 1-RM
Changes in weight Baseline, 6 months,12 months Measured in kilograms
Changes in the Short Form 36 (SF-36) Physical Health Component subscale Baseline, 6 months,12 months Score range is from 0 to 100 where higher scores indicate better physical health
Changes in the Short Form 36 (SF-36) Bodily Pain subscale Baseline, 6 months,12 months Score range is from 0 to 100 where higher scores indicate less pain
Changes in the Short Form 36 (SF-36) Social Functioning subscale Baseline, 6 months,12 months Score range is from 0 to 100 where higher scores indicate higher functioning
Changes in the Cancer Distress Scales for AYAs Impact of Cancer subscale Baseline, 6 months,12 months Scores range from 0 to 100 where higher scores indicate more distress
Changes in the Functional Assessment of Cancer Therapy Cognitive Function (FACT-Cog) Comments From Others subscale Baseline, 6 months,12 months Score range is from 0 to 16 where higher scores indicate poorer cognition
Changes in waist and hip circumference Baseline, 6 months,12 months Measured in centimeters
Changes in grip strength Baseline, 6 months,12 months Measured in kilograms using a hand dynamometer
Changes in frailty 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
Changes in the Short Form 36 (SF-36) Physical Functioning subscale Baseline, 6 months,12 months Score range is from 0 to 100 where higher scores indicate higher functioning
Changes in the Short Form 36 (SF-36) Role-emotional subscale Baseline, 6 months,12 months Score range is from 0 to 100 where higher scores indicate higher functioning
Changes in the Short Form 36 Mental Health subscale Baseline, 6 months,12 months Score range is from 0 to 100 where higher scores indicate better mental health
Changes in the Cancer Distress Scales for AYAs Education subscale Baseline, 6 months,12 months Scores range from 0 to 100 where higher scores indicate more distress
Changes in the Cancer Distress Scales for AYAs Practical subscale Baseline, 6 months,12 months Scores range from 0 to 100 where higher scores indicate more distress
Changes in lower body muscular strength Baseline, 6 months,12 months Measured in kilograms using an 8-10 repetition maximum (RM) leg press test used to predict 1-RM
Changes in the Comprehensive Score for Financial Toxicity (COST) Baseline, 6 months,12 months Score range is from 0 to 44 where higher scores indicate better financial wellbeing
Changes in weekly minutes of sleep Baseline, 6 months,12 months Measured by Actigraph
Changes in body mass index (BMI) Baseline, 6 months,12 months Measured by combining height (meters) and weight (kilograms) and reported in kg/m2
Changes in cardiorespiratory fitness 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
Changes in the Short Form 36 (SF-36) Vitality subscale Baseline, 6 months,12 months Score range is from 0 to 100 where higher scores indicate higher vitality
Changes in the Cancer Distress Scales for AYAs Physical subscale Baseline, 6 months,12 months Scores range from 0 to 100 where higher scores indicate more distress
Changes in the Cancer Distress Scales for AYAs Cognitive subscale Baseline, 6 months,12 months Scores range from 0 to 100 where higher scores indicate more distress
Changes in the Cancer Distress Scales for AYAs Cancer Worry subscale Baseline, 6 months,12 months Scores range from 0 to 100 where higher scores indicate more distress
Changes in the Cancer Distress Scales for AYAs Employment subscale Baseline, 6 months,12 months Scores range from 0 to 100 where higher scores indicate more distress
Changes in the Short Form 36 (SF-36) Role-physical subscale Baseline, 6 months,12 months Score range is from 0 to 100 where higher scores indicate higher functioning
Changes in the Short Form 36 (SF-36) General Health subscale Baseline, 6 months,12 months Score range is from 0 to 100 where higher scores indicate better health
Changes in the Cancer Distress Scales for AYAs Emotional subscale Baseline, 6 months,12 months Scores range from 0 to 100 where higher scores indicate more distress
Changes in the Functional Assessment of Cancer Therapy Fatigue (FACT-F) Baseline, 6 months,12 months Score range is from 0 to 52 where higher scores indicate less fatigue
Changes in the Functional Assessment of Cancer Therapy Cognitive Function Perceived Cognitive Impairment subscale Baseline, 6 months,12 months Score range is from 0 to 80. Higher scores indicate poorer quality of life.
Changes in the Functional Assessment of Cancer Therapy Cognitive Function (FACT-Cog) Perceived Cognitive Abilities subscale Baseline, 6 months,12 months Score range is from 0 to 36 where higher scores indicate poorer cognition
Changes in the Functional Assessment of Cancer Therapy Cognitive Function (FACT-Cog) Impact on Quality of Life subscale Baseline, 6 months,12 months Score range is from 0 to 16 where higher scores indicate poorer cognition
Trial Locations
- Locations (1)
Arthur J.E. Child Comprehensive Cancer Centre
🇨🇦Calgary, Alberta, Canada