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PreView: The Preventive Video Education in Waiting Rooms Program

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02264782
Recruitment Status : Completed
First Posted : October 15, 2014
Last Update Posted : May 17, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE October 6, 2014
First Posted Date  ICMJE October 15, 2014
Last Update Posted Date May 17, 2019
Study Start Date  ICMJE July 2013
Actual Primary Completion Date February 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 25, 2018)
  • Changing participants' readiness to be screened for breast, cervical and colorectal cancer [ Time Frame: Up to 3 hours from pre-visit to post-visit interview. ]
    To determine the extent to which PreView increases the likelihood that primary care patient participants will receive mammograms, Pap tests, colon cancer tests or PSA testing discussions with primary care physicians compared with participants who receive usual care
  • Increasing physician-patient discussions about PSA screening measured by chart review [ Time Frame: Baseline up to 14 months ]
    To determine the extent that PreView increases participants' readiness to be screened for breast cancer, cervical cancer or CRC compared with usual care.
  • Increasing rates of breast, cervical and colorectal cancer screening [ Time Frame: From Baseline up to 14 months ]
    To determine the extent that PRE-VIEW increases the likelihood that PSA testing will be discussed in primary care physician visits compared with usual care.
Original Primary Outcome Measures  ICMJE
 (submitted: October 9, 2014)
Receipt of screening [ Time Frame: 12 months ]
Data on receipt of screenings (including mammogram, Pap test, fecal occult blood test (FOBT), sigmoidoscopy (SIG), colonoscopy (COL), and prostate cancer screening) will be collected for up to one year after the intervention. The outcome data must be collected by chart review. The information collected will include the test received and the date it was done or that the discussion occurred.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2014)
  • History of prior cancer screening [ Time Frame: baseline ]
    Collected via computer during the initial assessment
  • Stages of change [ Time Frame: baseline, post-visit (estimated within 2 hours) ]
    Collected using the computer during the initial assessment and the post-visit assessment.
  • Perceived barriers to screening [ Time Frame: Baseline, post-visit (estimated within 2 hours) ]
    Collected using the computer during the initial assessment and the post-visit assessment.
  • Readiness to be screened or to discuss screening [ Time Frame: Baseline, post-visit (estimated within 2 hours) ]
    Collected using the computer during the initial assessment and the post-visit assessment.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PreView: The Preventive Video Education in Waiting Rooms Program
Official Title  ICMJE PreView: The Preventive Video Education in Waiting Rooms Program
Brief Summary This clinical trial studies how well PreView, preventive video education, works in increasing rates of breast, cervical and colorectal cancer screening, improving participants' stage of change with respect to age appropriate cancer screening and increasing patient-provider discussions about prostate cancer screening.
Detailed Description

PRIMARY OBJECTIVES:

I. To determine the extent to which PreView increases the likelihood that primary care patient participants will receive mammograms, pap tests, colon cancer tests or prostate specific antigen (PSA) testing discussions with primary care physicians compared with participants who receive usual care.

II. To determine the extent that PreView increases participants' readiness to be screened for breast cancer, cervical cancer or colorectal cancer (CRC) compared with usual care.

III. To determine the extent that PreView increases the likelihood that PSA testing will be discussed in primary care physician visits compared with usual care.

OUTLINE: Patients are randomized into 1 of 2 groups.

GROUP I: Patients complete PreView, the Video Doctor plus Provider Alert, over 45 minutes on an iPad in the waiting room before a doctor visit.

GROUP II: Patients watch a video about healthy lifestyles including information about exercise and healthy eating over 45 minutes on an iPad in the waiting room before a doctor visit.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Screening
Condition  ICMJE Health Status Unknown
Intervention  ICMJE
  • Other: Computer-Assisted Intervention
    Complete PreView
  • Other: Computer-Assisted Intervention
    Watch an educational video
  • Other: Questionnaire Administration
    Ancillary studies
Study Arms  ICMJE
  • Experimental: Group I (PreView)
    Patients complete PreView, the Video Doctor plus Provider Alert, over 45 minutes on an iPad in the waiting room before a doctor visit.
    Interventions:
    • Other: Computer-Assisted Intervention
    • Other: Questionnaire Administration
  • Active Comparator: Group II (educational video)
    Patients watch a video about healthy lifestyles including information about exercise and healthy eating over 45 minutes on an iPad in the waiting room before a doctor visit.
    Interventions:
    • Other: Computer-Assisted Intervention
    • Other: Questionnaire Administration
Publications * Walsh J, Potter M, Salazar R, Ozer E, Gildengorin G, Dass N, Green L. PreView: a Randomized Trial of a Multi-site Intervention in Diverse Primary Care to Increase Rates of Age-Appropriate Cancer Screening. J Gen Intern Med. 2020 Feb;35(2):449-456. doi: 10.1007/s11606-019-05438-0. Epub 2019 Nov 14.

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: May 15, 2019)
508
Original Estimated Enrollment  ICMJE
 (submitted: October 9, 2014)
572
Actual Study Completion Date  ICMJE March 2019
Actual Primary Completion Date February 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Without a history of cancer

Exclusion Criteria:

  • With a history of cancer (for whom subsequent procedures would be surveillance and not screening)
  • Individuals who do not speak English or Spanish (except for the testimonials)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
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 NCT02264782
Other Study ID Numbers  ICMJE 14988
NCI-2017-00456 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
14988 ( Other Identifier: UCSF Medical Center-Mount Zion )
P30CA082103 ( U.S. NIH Grant/Contract )
R01CA158027 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Judith Walsh UCSF Medical Center-Mount Zion
PRS Account University of California, San Francisco
Verification Date May 2019

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