Clinical trial NCT04601948: AYActive Study! A Physical Health Activity Intervention
Official title: AYActive Study! A Physical Health Activity Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: Adolescents
Young Adults
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: University of Iowa
First posted: 2020-10-26
Enrollment: 14
Sex: ALL
Minimum age (years): 13
Maximum age (years): 39
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Number of steps taken per day
timeFrame: Dail steps will be measured each day of the intervention for 7 weeks
Secondary outcomes:
measure: PROMIS Fatigue Scale
timeFrame: Change in fatigue over 7 weeks
measure: PROMISE Pain Scale
timeFrame: Change in pain over 7 weeks
measure: PROMIS Physical Function Scale
timeFrame: Change in physical function over 7 weeks
measure: PROMIS Depression Scale
timeFrame: Change in depression over 7 weeks
measure: PROMIS Anxiety Scale
timeFrame: Change in anxiety over 7 weeks
measure: Exercise Self-Regulatory Efficacy
timeFrame: Change in exercise self regulatory efficacy over 7 weeks
measure: Social Support for exercise
timeFrame: Change in social support for exercise over 7 weeks
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
Study officials:
affiliation: University of Iowa
name: Lucas Carr, PhD
role: PRINCIPAL_INVESTIGATOR
References: