Lung CancerNCT04980521
Promoting Radon Testing Via Smartphone App: A Clinical Trial in a High Radon State
A study testing The radon app and Print brochure in people with Lung Cancer, run by University of North Dakota at 1 site in United States.
Trial summary
This research will compare (1) the effectiveness of a mobile radon-education app (vs. traditional brochures) and (2) that of the radon app with in-app reminders (vs. the radon app without in-app reminders and the no app use with postal reminders) to increase radon awareness and testing among North Dakotans. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer
- What is being tested?
- The radon app and Print brochure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 138 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2021to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The principal eligibility criterion is that participants own a smartphone.
Who cannot join
- The principal exclusion criterion is previous testing for radon within the past two years.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Dakota
Grand Forks, North Dakota, 58202
About this study
This research will compare (1) the effectiveness of a mobile radon-education app (vs. traditional brochures) and (2) that of the radon app with in-app reminders (vs. the radon app without in-app reminders and the no app use with postal reminders) to increase radon awareness and testing among North Dakotans. The prevalence of exceptionally high levels of residential radon in North Dakota (ND), coupled with public's poor understanding of this hazard, is a critical public health problem.
- Conditions
- Lung Cancer
- Being tested
- The radon app, Print brochure
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The radon appOther
Participants will be asked to use the radon app.
Print brochureOther
Participants will receive print brochures.
| Study group | Role | What they receive |
|---|---|---|
| Print brochures | Placebo comparator | Participants assigned to the print brochure group will receive three educational print brochures about radon published by EPA via postal mails for three months (one per each month). Receives: Other: Print brochure |
| The radon app | Experimental | Participants assigned to the radon app group will be asked to use the radon app for three months where they will be exposed to mobile friendly educational content that is created from educational print brochures about radon published by EPA. Receives: Other: The radon app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ordering a Free Radon Test Kit
The rate at which participants order a free radon test kit
Measured: Through the study completion - 3 months
Using the Radon Test Kit
The rate at which participants use the radon test kit to test their houses
Measured: Through the study completion - 3 months
Secondary outcomes (1)
Change From Baseline Radon Knowledge at 3 Months
Radon knowledge was measured by the number of accurate responses to 20 True-False statements in T1 (baseline) and T2 (at 3 months), as used in Kim, Brewster, and Schwartz (2020) (PMID: 32321499). The response options were: "true," "false," and "I don't know." Participants' responses to each statement were then re-coded to 1 ("correct") or 0 ("incorrect" or "I don't know"). After that, two radon knowledge index variables (continuous) were created by summing participants' responses to each statement in T1 (baseline) and T2 (at 3 months). Thus, two radon knowledge scores can range from 0-20 with higher scores indicating better knowledge.
Measured: Change from baseline knowledge level to the completion of study at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start1 Oct 2021
- Primary completion15 Feb 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Dakota
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Principal investigator, Soojung Kim, University of North Dakota
- Investigators
- Soojung Kim, Principal investigator, University of North Dakota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04980521
- Sponsor's protocol ID
- CTR radon DaCCoTA
- Other IDs
- 5U54GM128729-05
- Status last verified
- Aug 2024
- First submitted
- 6 Jul 2021
- Last updated
- 9 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim S, Chiu T, Klug MG, Schmitz D, Schwartz GG. Interventions to promote home radon testing: A randomized clinical trial of a smartphone app vs. printed brochures. Cancer Med. 2023 Jan;12(2):2027-2032. doi: 10.1002/cam4.4988. Epub 2022 Jun 28.
PubMed 35762397
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Radon Testing Via Smartphone App: A Clinical Trial in a High Radon State
- ClinicalTrials.gov ID
- NCT04980521
- Acronym / sponsor ID
- CTR radon DaCCoTA
- Conditions
- Lung Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- University of North DakotaUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 15 Feb 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 28 Jul 2021 (actual)
- Results
- Posted 9 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research will compare (1) the effectiveness of a mobile radon-education app (vs. traditional brochures) and (2) that of the radon app with in-app reminders (vs. the radon app without in-app reminders and the no app use with postal reminders) to increase radon awareness and testing among North Dakotans. The prevalence of exceptionally high levels of residential radon in North Dakota (ND), coupled with public's poor understanding of this hazard, is a critical public health problem.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Print brochures | Placebo comparator | Other: Print brochureParticipants assigned to the print brochure group will receive three educational print brochures about radon published by EPA via postal mails for three months (one per each month). |
| The radon app | Experimental | Other: The radon appParticipants assigned to the radon app group will be asked to use the radon app for three months where they will be exposed to mobile friendly educational content that is created from educational print brochures about radon published by EPA. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The principal eligibility criterion is that participants own a smartphone.
Key exclusion criteria (1 listed)
- The principal exclusion criterion is previous testing for radon within the past two years.
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 |
|---|---|---|
| The radon appParticipants will be asked to use the radon app. | Other | The radon app |
| Print brochureParticipants will receive print brochures. | Other | Print brochures |
Primary outcome
Ordering a Free Radon Test Kit
Time frame: Through the study completion - 3 months
The rate at which participants order a free radon test kit
Using the Radon Test Kit
Time frame: Through the study completion - 3 months
The rate at which participants use the radon test kit to test their houses
1 secondary outcome
Change From Baseline Radon Knowledge at 3 Months
Time frame: Change from baseline knowledge level to the completion of study at 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 35762397Kim S, Chiu T, Klug MG, Schmitz D, Schwartz GG. Interventions to promote home radon testing: A randomized clinical trial of a smartphone app vs. printed brochures. Cancer Med. 2023 Jan;12(2):2027-2032. doi: 10.1002/cam4.4988. Epub 2022 Jun 28.
- 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.
Soojung Kim principal investigator
University of North Dakota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The radon app and Print brochure in people with Lung Cancer, run by University of North Dakota 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 1 inclusion and 1 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 9 Aug 2024. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 9 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Ordering a Free Radon Test Kit (time frame: Through the study completion - 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04980521, which also lists 1 linked publication.
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 9 Aug 2024.