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Completed

NCT Number: NCT04601948

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.

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Key information

Conditions

Cancer Neoplasms

Age range

13 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Iowa

Iowa City, Iowa, 52242, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

mHealth Activity Intervention

Behavioral

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.

Primary outcomes

  1. Number of steps taken per day

    Time frame: Dail steps will be measured each day of the intervention for 7 weeks

    Number of steps taken per day on each day of the intervention

Secondary outcomes

  1. PROMIS Fatigue Scale

    Time frame: Change in fatigue over 7 weeks

    8 item scale, lower score is better

  2. PROMISE Pain Scale

    Time frame: Change in pain over 7 weeks

    8 item scale, lower score is better

  3. PROMIS Physical Function Scale

    Time frame: Change in physical function over 7 weeks

    8 item scale, lower score is better

  4. PROMIS Depression Scale

    Time frame: Change in depression over 7 weeks

    8 item scale, lower score is better

  5. PROMIS Anxiety Scale

    Time frame: Change in anxiety over 7 weeks

    8 item scale, lower score is better

  6. Exercise Self-Regulatory Efficacy

    Time frame: Change in exercise self regulatory efficacy over 7 weeks

    20 item scale, higher score is better

  7. Social Support for exercise

    Time frame: Change in social support for exercise over 7 weeks

    13 item scale, higher score is better

Sponsors and collaborators

Lead sponsor

Lucas Carr

Other

Collaborators

  • University of Iowa

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 26, 2020
Registry last updated
May 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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