NCT02264782

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
508

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

October 6, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 15, 2014

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

July 22, 2020

Status Verified

July 1, 2020

Enrollment Period

5.6 years

First QC Date

October 6, 2014

Last Update Submit

July 20, 2020

Conditions

Outcome Measures

Primary Outcomes (3)

  • Changing participants' readiness to be screened for breast, cervical and colorectal cancer

    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

    Up to 3 hours from pre-visit to post-visit interview.

  • Increasing physician-patient discussions about PSA screening measured by chart review

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

    Baseline up to 14 months

  • Increasing rates of breast, cervical and colorectal cancer screening

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

    From Baseline up to 14 months

Study Arms (2)

Group I (PreView)

EXPERIMENTAL

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

Other: Computer-Assisted InterventionOther: Questionnaire Administration

Group II (educational video)

ACTIVE COMPARATOR

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.

Other: Computer-Assisted InterventionOther: Questionnaire Administration

Interventions

Complete PreView

Group I (PreView)

Ancillary studies

Group I (PreView)Group II (educational video)

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Without a history of cancer

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

John Muir Medical Center-Concord Campus

Concord, California, 94520, United States

Location

UCSF Medical Center-Mount Zion

San Francisco, California, 94115, United States

Location

Related Publications (1)

  • 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.

Study Officials

  • Judith Walsh

    UCSF Medical Center-Mount Zion

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2014

First Posted

October 15, 2014

Study Start

July 1, 2013

Primary Completion

February 1, 2019

Study Completion

March 1, 2019

Last Updated

July 22, 2020

Record last verified: 2020-07

Locations