Clinical trial NCT04765241: mHealth Physical Activity Intervention for Young Cancer Survivors
Official title: Adolescents and Young Adults Becoming Physically Active After Cancer Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cancer
Keywords: Adolescent cancer
Young adult cancer
Physical activity
mHealth
Survivorship
AYA cancer
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
Collaborators: name: University of Calgary
First posted: 2021-02-21
Enrollment: 287
Sex: ALL
Minimum age (years): 15
Maximum age (years): 39
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in weekly minutes of moderate-vigorous intensity physical activity
timeFrame: Baseline, 6 months, 12 months, 24 months
Secondary outcomes:
measure: Changes in weekly minutes of sedentary time
timeFrame: Baseline, 6 months,12 months
measure: Changes in weekly minutes of sleep
timeFrame: Baseline, 6 months,12 months
measure: Changes in the Pittsburgh Sleep Quality Index (PSQI) Global Sleep Quality Score
timeFrame: Baseline, 6 months,12 months
measure: Changes in weight
timeFrame: Baseline, 6 months,12 months
measure: Changes in body mass index (BMI)
timeFrame: Baseline, 6 months,12 months
measure: Changes in waist and hip circumference
timeFrame: Baseline, 6 months,12 months
measure: Changes in cardiorespiratory fitness
timeFrame: Baseline, 6 months,12 months
measure: Changes in cardiorespiratory fitness
timeFrame: Baseline, 6 months,12 months
measure: Changes in grip strength
timeFrame: Baseline, 6 months,12 months
measure: Changes in upper body muscular strength
timeFrame: Baseline, 6 months,12 months
measure: Changes in upper body muscular endurance
timeFrame: Baseline, 6 months,12 months
measure: Changes in lower body muscular strength
timeFrame: Baseline, 6 months,12 months
measure: Changes in lower body muscular endurance
timeFrame: Baseline, 6 months,12 months
measure: Changes in frailty
timeFrame: Baseline, 6 months,12 months
measure: Changes in the Short Form 36 (SF-36) Mental Health Component subscale
timeFrame: Baseline, 6 months,12 months
measure: Changes in the Short Form 36 (SF-36) Physical Health Component subscale
timeFrame: Baseline, 6 months,12 months
measure: Changes in the Short Form 36 (SF-36) Physical Functioning subscale
timeFrame: Baseline, 6 months,12 months
measure: Changes in the Short Form 36 (SF-36) Role-physical subscale
timeFrame: Baseline, 6 months,12 months
measure: Changes in the Short Form 36 (SF-36) Bodily Pain subscale
timeFrame: Baseline, 6 months,12 months
measure: Changes in the Short Form 36 (SF-36) General Health subscale
timeFrame: Baseline, 6 months,12 months
measure: Changes in the Short Form 36 (SF-36) Vitality subscale
timeFrame: Baseline, 6 months,12 months
measure: Changes in the Short Form 36 (SF-36) Social Functioning subscale
timeFrame: Baseline, 6 months,12 months
measure: Changes in the Short Form 36 (SF-36) Role-emotional subscale
timeFrame: Baseline, 6 months,12 months
measure: Changes in the Short Form 36 Mental Health subscale
timeFrame: Baseline, 6 months,12 months
measure: Changes in the Cancer Distress Scales for AYAs Impact of Cancer subscale
timeFrame: Baseline, 6 months,12 months
measure: Changes in the Cancer Distress Scales for AYAs Physical subscale
timeFrame: Baseline, 6 months,12 months
measure: Changes in the Cancer Distress Scales for AYAs Emotional subscale
timeFrame: Baseline, 6 months,12 months
measure: Changes in the Cancer Distress Scales for AYAs Cognitive subscale
timeFrame: Baseline, 6 months,12 months
measure: Changes in the Cancer Distress Scales for AYAs Cancer Worry subscale
timeFrame: Baseline, 6 months,12 months
measure: Changes in the Cancer Distress Scales for AYAs Employment subscale
timeFrame: Baseline, 6 months,12 months
measure: Changes in the Cancer Distress Scales for AYAs Education subscale
timeFrame: Baseline, 6 months,12 months
measure: Changes in the Cancer Distress Scales for AYAs Practical subscale
timeFrame: Baseline, 6 months,12 months
measure: Changes in the Functional Assessment of Cancer Therapy Cognitive Function Perceived Cognitive Impairment subscale
timeFrame: Baseline, 6 months,12 months
measure: Changes in the Functional Assessment of Cancer Therapy Cognitive Function (FACT-Cog) Comments From Others subscale
timeFrame: Baseline, 6 months,12 months
measure: Changes in the Functional Assessment of Cancer Therapy Cognitive Function (FACT-Cog) Perceived Cognitive Abilities subscale
timeFrame: Baseline, 6 months,12 months
measure: Changes in the Functional Assessment of Cancer Therapy Cognitive Function (FACT-Cog) Impact on Quality of Life subscale
timeFrame: Baseline, 6 months,12 months
measure: Changes in the Functional Assessment of Cancer Therapy Fatigue (FACT-F)
timeFrame: Baseline, 6 months,12 months
measure: Changes in the Comprehensive Score for Financial Toxicity (COST)
timeFrame: Baseline, 6 months,12 months
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Arthur J.E. Child Comprehensive Cancer Centre
state: Alberta
Study officials:
affiliation: Alberta Health services
name: Christine Friedenreich
role: STUDY_DIRECTOR
affiliation: Alberta Health services
name: Miranda Fidler-Benaoudia
role: PRINCIPAL_INVESTIGATOR
References: