AYActive Study! A Physical Health Activity Intervention

Cancer Clinical Trial

Official title:

AYActive Study! A Physical Health Activity Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04601948
• Other study ID #: 201907702
• Status: Completed
• Phase: N/A
• Start date: November 6, 2019
• Est. completion date: September 4, 2020

Study information

• Verified date: May 2023
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: September 4, 2020
• Est. primary completion date: September 4, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 39 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	University of Iowa	Iowa City	Iowa

Sponsors (2)

Lead Sponsor	Collaborator
Lucas Carr	University of Iowa

Country where clinical trial is conducted

United States, 

Outcome

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