AYActive Study! A Physical Health Activity Intervention

Study Overview
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Brief Summary
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The purpose of this pilot study is to explore the feasibility, acceptability, and efficacy of a 6-week mobile health (mHealth) physical activity intervention among adolescent and young adult (AYA) cancer survivors being treated at the University of Iowa Hospitals and Clinics.

Detailed Description
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The purpose of this pilot study is to explore the feasibility, acceptability, and efficacy of a 6-week mobile health (mHealth) physical activity intervention among adolescent and young adult (AYA) cancer survivors being treated at the University of Iowa Hospitals and Clinics. Eligible participants will receive a Fitbit activity monitor and access to the mHealth physical activity intervention for 6 weeks. The intervention will include regular motivational messages to encourage activity, a social media thread to provide social support, and a series of fun virtual walking races. AYA cancer survivors between 13-39 years are invited to participate and the impact of this intervention will be tested over 6 weeks.

Official Title
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AYActive Study! A Physical Health Activity Intervention

Conditions
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Cancer

Intervention / Treatment
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* Behavioral: mHealth Activity Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female cancer survivors Diagnosed between 13 and 39 years old Currently 3-24 months post-treatment (or in maintenance therapy) Receiving survivorship care at HCCC/UIHC In remission Physically able to walk without limitations Own a smartphone with a data plan that is also capable of receiving and sending texts Able to understand English and provide informed assent/consent Exclusion Criteria: Physically unable to walk without limitations Actively receiving cancer treatment Does not own a smartphone with a data plan Visual or cognitive impairments causing inability to read, complete or sign the consent form and survey Participants with diagnosis of thyroid cancer (due to differences in physical, psychological, emotional, and social effects) Presence of a psychiatric disorder that is not managed/unstable or suicidal ideation/actuation in preceding 12 months Currently meeting physical activity requirements per American Cancer Society guidelines (150 or more minutes per week of moderate to vigorous physical activity)

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: The intervention will include an activity monitor and access to the mHealth physical activity intervention for 6 weeks. The intervention will include regular motivational messages to encourage activity, a social media thread to provide social support, and a series of fun virtual walking races.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Participants will receive a Fitbit activity monitor and access to the mHealth physical activity intervention for 6 weeks. The intervention will include regular motivational messages to encourage activity, a social media thread to provide social support, and a series of fun virtual walking races. | Behavioral: mHealth Activity Intervention<br>* Eligible participants will receive a Fitbit activity monitor and access to our mHealth physical activity intervention for 6 weeks. The intervention will include regular motivational messages to encourage activity, a social media thread to provide social support, and a series of fun virtual walking races.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of steps taken per day | Number of steps taken per day on each day of the intervention | Dail steps will be measured each day of the intervention for 7 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PROMIS Fatigue Scale | 8 item scale, lower score is better | Change in fatigue over 7 weeks | 
| PROMISE Pain Scale | 8 item scale, lower score is better | Change in pain over 7 weeks | 
| PROMIS Physical Function Scale | 8 item scale, lower score is better | Change in physical function over 7 weeks | 
| PROMIS Depression Scale | 8 item scale, lower score is better | Change in depression over 7 weeks | 
| PROMIS Anxiety Scale | 8 item scale, lower score is better | Change in anxiety over 7 weeks | 
| Exercise Self-Regulatory Efficacy | 20 item scale, higher score is better | Change in exercise self regulatory efficacy over 7 weeks | 
| Social Support for exercise | 13 item scale, higher score is better | Change in social support for exercise over 7 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adolescents, Young Adults