CancerNCT04601948
AYActive Study! A Physical Health Activity Intervention
A study testing mHealth Activity Intervention in people with Cancer, run by Lucas Carr at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 13 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- mHealth Activity Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2019to 4 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 39 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
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.
Read the 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.
- Conditions
- Cancer
- Being tested
- mHealth Activity Intervention
- Keywords
- Adolescents, Young Adults
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mHealth Activity InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Behavioral: mHealth Activity Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of steps taken per day
Number of steps taken per day on each day of the intervention
Measured: Dail steps will be measured each day of the intervention for 7 weeks
Secondary outcomes (7)
PROMIS Fatigue Scale
8 item scale, lower score is better
Measured: Change in fatigue over 7 weeks
PROMISE Pain Scale
8 item scale, lower score is better
Measured: Change in pain over 7 weeks
PROMIS Physical Function Scale
8 item scale, lower score is better
Measured: Change in physical function over 7 weeks
PROMIS Depression Scale
8 item scale, lower score is better
Measured: Change in depression over 7 weeks
PROMIS Anxiety Scale
8 item scale, lower score is better
Measured: Change in anxiety over 7 weeks
Exercise Self-Regulatory Efficacy
20 item scale, higher score is better
Measured: Change in exercise self regulatory efficacy over 7 weeks
Social Support for exercise
13 item scale, higher score is better
Measured: Change in social support for exercise over 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2020
- Study start6 Nov 2019
- Primary completion4 Sep 2020
- Study completion4 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lucas Carr
- Sponsor type
- University, hospital or other
- Collaborators
- University of Iowa
- Responsible party
- Sponsor-investigator, Lucas Carr, University of Iowa
- Investigators
- Lucas Carr, PhD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04601948
- Sponsor's protocol ID
- 201907702
- Status last verified
- May 2023
- First submitted
- 18 Nov 2019
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AYActive Study! A Physical Health Activity Intervention
- ClinicalTrials.gov ID
- NCT04601948
- Acronym / sponsor ID
- 201907702
- Conditions
- Cancer
- Keywords
- Adolescents, Young Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Lucas CarrUniversity, hospital or other
- Collaborators
- University of Iowa
- Study start
- 6 Nov 2019 (actual)
- Primary completion
- 4 Sep 2020 (actual)
- Study completion
- 4 Sep 2020 (actual)
- First posted
- 26 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: mHealth Activity InterventionParticipants 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. |
Who may qualify
- Ages
- 13 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mHealth Activity InterventionEligible 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. | Behavioural | Intervention |
Primary outcome
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
7 secondary outcomes
PROMIS Fatigue Scale
Time frame: Change in fatigue over 7 weeks
PROMISE Pain Scale
Time frame: Change in pain over 7 weeks
PROMIS Physical Function Scale
Time frame: Change in physical function over 7 weeks
PROMIS Depression Scale
Time frame: Change in depression over 7 weeks
PROMIS Anxiety Scale
Time frame: Change in anxiety over 7 weeks
Exercise Self-Regulatory Efficacy
Time frame: Change in exercise self regulatory efficacy over 7 weeks
Social Support for exercise
Time frame: Change in social support for exercise over 7 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucas Carr, PhD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mHealth Activity Intervention in people with Cancer, run by Lucas Carr at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of steps taken per day (time frame: Dail steps will be measured each day of the intervention for 7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2023.