Health Status UnknownNCT02264782
PreView: The Preventive Video Education in Waiting Rooms Program
A study testing Computer-Assisted Intervention and Questionnaire Administration in people with Health Status Unknown, run by University of California, San Francisco at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Health Status Unknown
- What is being tested?
- Computer-Assisted Intervention and Questionnaire Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 508 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2013to Mar 2019
- 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 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Without a history of cancer
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
John Muir Medical Center-Concord Campus
Concord, California, 94520
UCSF Medical Center-Mount Zion
San Francisco, California, 94115
About this study
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Health Status Unknown
- Being tested
- Computer-Assisted Intervention, Questionnaire Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer-Assisted InterventionOther
Complete PreView
Computer-Assisted InterventionOther
Watch an educational video
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Computer-Assisted Intervention; Other: 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. Receives: Other: Computer-Assisted Intervention; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: From Baseline up to 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2014 (estimated)
- Study startJul 2013
- Primary completionFeb 2019
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Health Status UnknownStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 508 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Judith Walsh, Principal investigator, UCSF Medical Center-Mount Zion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02264782
- Sponsor's protocol ID
- 14988
- Other IDs
- NCI-2017-00456, 14988, R01CA158027
- Status last verified
- Jul 2020
- First submitted
- 6 Oct 2014
- Last updated
- 22 Jul 2020
- Results posted
- No
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.
PubMed 31728894
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PreView: The Preventive Video Education in Waiting Rooms Program
- ClinicalTrials.gov ID
- NCT02264782
- Acronym / sponsor ID
- 14988
- Conditions
- Health Status Unknown
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 508 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2013
- Primary completion
- Feb 2019 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 15 Oct 2014 (estimated)
- 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.
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:
- 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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (PreView) | Experimental | Other: Computer-Assisted Intervention, Other: Questionnaire AdministrationPatients complete PreView, the Video Doctor plus Provider Alert, over 45 minutes on an iPad in the waiting room before a doctor visit. |
| Group II (educational video) | Active comparator | Other: Computer-Assisted Intervention, Other: Questionnaire AdministrationPatients 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. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Without a history of cancer
Key exclusion criteria (2 listed)
- 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)
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 |
|---|---|---|
| Computer-Assisted InterventionComplete PreView | Other | Group I (PreView) |
| Computer-Assisted InterventionWatch an educational video | Other | Group II (educational video) |
| Questionnaire AdministrationAncillary studies | Other | Group I (PreView), Group II (educational video) |
Primary outcome
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 PreView increases the likelihood that PSA testing will be discussed in primary care physician visits compared with usual care.
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 22 Jul 2020.
- Derived from this study: PubMed 31728894Walsh 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.
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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.
Judith Walsh principal investigator
UCSF Medical Center-Mount Zion
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer-Assisted Intervention and Questionnaire Administration in people with Health Status Unknown, run by University of California, San Francisco at 2 sites 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 2 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 22 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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.). The study lists 3 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 NCT02264782, 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 22 Jul 2020.