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Utilizing Technology to Promote Cancer Prevention

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ClinicalTrials.gov Identifier: NCT03810053
Recruitment Status : Active, not recruiting
First Posted : January 18, 2019
Last Update Posted : September 4, 2019
Sponsor:
Information provided by (Responsible Party):
University of Arkansas

Tracking Information
First Submitted Date  ICMJE January 9, 2019
First Posted Date  ICMJE January 18, 2019
Last Update Posted Date September 4, 2019
Actual Study Start Date  ICMJE March 1, 2019
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 17, 2019)
  • The Effectiveness of an Online Module in Teaching New Information [ Time Frame: up to 6 Months ]
    This study will address the number of participants who have learned something new from the development of a health application for cell phones or an online module.
  • The Effectiveness of an Online Module in Identifying Needed Interventions [ Time Frame: up to 6 months ]
    The study will also address the number of participants that identified interventions that they have not yet adopted from the use of the health application.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03810053 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Utilizing Technology to Promote Cancer Prevention
Official Title  ICMJE Utilizing Technology to Promote Cancer Prevention
Brief Summary The goal of the program is to develop an online module/a health application for cell phones which will share didactic information regarding cancer prevention and early detection measures. These module/application will be developed, and be tested among volunteers for feedback. In the future, these module/application will be disseminated widely to address cancer health disparity particularly in Arkansas.
Detailed Description The application or the online module will play a short didactic explanation video that will provide information about cancers and benefits of uptake of cancer prevention and early detection measures. It is currently unknown which method will be used, the online module or the application for the purpose. The study participants will be subjected to only one method (once the method have been finalized and created). The video content will engulf information about cervical, breast, colorectal and lung cancer prevention and early detection. After the video, the application or the module will capture information on gender, age, smoking status, body mass index and positive cancer history in family. Watching the video and answering the questions will take approximately 5 minutes. The study participants will download the application on their personal cell phones and the data collected will be linked to identifying information in case they choose to receive the compensation and opt for the 6-month follow-up. Based on the responses provided, and the age and the gender, the participants will be provided with a list of cancer prevention and early detection measure(s). A subset of the study participants from ARResearch (only those who have agreed for the 6-month follow-up) will be asked if they are willing to be contacted by the study staff after 6 ±1 months (from the date of enrollment in the study) to enquire if they received/adopted the screening measures(s) that were suggested based on their age, gender and family history. They will be asked whether it is OK to call and/or e-mail them for more information to better describe barriers to obtaining cancer prevention and screening measures.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Health Knowledge, Attitudes, Practice
Intervention  ICMJE Behavioral: Mobile App/Online Module
Short didactic explainer video that will provide information about cancers and benefits of uptake of cancer prevention and early detection measures.
Study Arms  ICMJE Experimental: Mobile App/Online Module
Subjects will watch a short video containing information about cancers and benefits of uptake cancer prevention and early detection measures. Information regarding gender, age, smoking status, BMI and positive cancer history in family will be captured. Subjects will be provided with a list of cancer prevention and early detection measures based on the responses provided.
Intervention: Behavioral: Mobile App/Online Module
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: September 3, 2019)
290
Original Estimated Enrollment  ICMJE
 (submitted: January 17, 2019)
300
Estimated Study Completion Date  ICMJE March 2020
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Any ARResearch volunteer.
  • 18 years or older in age.
  • Have access to a personal cell phone and/or computer

Exclusion Criteria:

  • Unable to give an informed consent.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03810053
Other Study ID Numbers  ICMJE 228815
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Arkansas
Study Sponsor  ICMJE University of Arkansas
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Maumi Nakagawa, Ph.D University of Arkansas
PRS Account University of Arkansas
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP