AYActive Study! A Physical Health Activity Intervention

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.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Behavioral: mHealth Activity Intervention

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 39 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Lucas Carr
• Collaborators: University of Iowa
• Investigators: Principal Investigator: Lucas Carr, PhD, University of Iowa

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2019
• Primary Completion (Actual): September 4, 2020
• Study Completion (Actual): September 4, 2020

Study Registration Dates

• First Submitted: November 18, 2019
• First Submitted That Met QC Criteria: October 20, 2020
• First Posted (Actual): October 26, 2020

Study Record Updates

• Last Update Posted (Actual): May 16, 2023
• Last Update Submitted That Met QC Criteria: May 11, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Adolescents; Young Adults
• Other Study ID Numbers: 201907702

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No