mHealth Physical Activity Intervention for Young Cancer Survivors

Cancer Clinical Trial

— AYA-PACT  

Official title:

Adolescents and Young Adults Becoming Physically Active After Cancer Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04765241
• Other study ID #: HREBA.CC-20-0397
• Status: Recruiting
• Phase: N/A
• Start date: September 27, 2021
• Est. completion date: September 2026

Study information

• Verified date: February 2024
• Source: AHS Cancer Control Alberta
• Contact: Leanne Dickau
• Phone: 4034762416
• Email: leanne.dickau[@]ahs.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: September 2026
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

Behavioral:
• Physical Activity
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.

Locations

Country	Name	City	State
Canada	Holy Cross Centre	Calgary	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
AHS Cancer Control Alberta	University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in weekly minutes of moderate-vigorous intensity physical activity	Measured by Actigraph	Baseline, 6 months, 12 months, 24 months
Secondary	Changes in weekly minutes of sedentary time	Measured by Actigraph	Baseline, 6 months,12 months
Secondary	Changes in weekly minutes of sleep	Measured by Actigraph	Baseline, 6 months,12 months
Secondary	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
Secondary	Changes in weight	Measured in kilograms	Baseline, 6 months,12 months
Secondary	Changes in body mass index (BMI)	Measured by combining height (meters) and weight (kilograms) and reported in kg/m2	Baseline, 6 months,12 months
Secondary	Changes in waist and hip circumference	Measured in centimeters	Baseline, 6 months,12 months
Secondary	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
Secondary	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
Secondary	Changes in grip strength	Measured in kilograms using a hand dynamometer	Baseline, 6 months,12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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