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Oral CancerNCT01424358

Web-based Education on Oral Cancer for Primary Care Physicians in Ohio

A study testing Web-based Educational Intervention in people with Oral Cancer, run by Creighton University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Objective: The experimental design is a one-site, randomized experimental web-based educational feasibility intervention trial, with approximately 50% primary care physicians (PCPs) in the intervention group and approximately 50% PCPs on the control group, giving a total of 159 participants. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Oral Cancer
What is being tested?
Web-based Educational Intervention
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
Jul 2011to Sep 2013
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • The PCP's who participated in Specific Aim #2 (Survey of Healthcare Professionals on Oral Cancer in Ohio ) of the NIH K23 grant proposal, "Intervention to Prevent Delayed Diagnosis of Oral Cancer", will be eligible to participate in this Web-Based Education on Oral Cancer.
  • Possessing the ability to give voluntary consent to participate. Participating in the web-based educational intervention is am implication of consent.
  • All participants are expected to be relatively healthy.

Who cannot join

  • Unable to have access to the internet to be able to participate in the web-based education.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Creighton University School of Dentistry

    Omaha, Nebraska, 68178

Other trials in United States

About this study

Objective:

The experimental design is a one-site, randomized experimental web-based educational feasibility intervention trial, with approximately 50% primary care physicians (PCPs) in the intervention group and approximately 50% PCPs on the control group, giving a total of 159 participants. All 159 participants have willingly provided their e-mail addresses, as part of a survey they previously completed entitled, "Survey of Health Professionals on Oral Cancer in Ohio- Intervention to Prevent Delayed Diagnosis of Oral Cancer."

Read the detailed description

The main specific aim is to determine the short-term effectiveness of a web-based educational intervention for primary care physicians (PCPs) in Ohio to improve the following:Index of knowledge of risk factors for oral cancer, and Index of knowledge of diagnostic procedures for oral cancer

The following hypothesis will be explored: The use of a web-based educational module for PCPs in Ohio regarding oral cancer will increase the proportion of the PCPs in the high score category for the following indices: Index of knowledge of risk factors of oral cancer, and Index of knowledge of diagnostic procedures for oral cancer

Conditions
Oral Cancer
Being tested
Web-based Educational Intervention
Medical subject headings
Mouth Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Web-based Educational InterventionOther

    The intervention group will be invited to participate in the web-based educational program. PCPs in the intervention group will be asked to view the educational module which will be followed by an assessment. This group will be tested on the following knowledge outcomes: Index of knowledge of risk factor for oral cancer and Index of knowledge of diagnostic procedures for oral cancer.

Study groups in NCT01424358
Study groupRoleWhat they receive
Web-based EducationalExperimentalNot described
Receives: Other: Web-based Educational Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Index of knowledge of diagnostic procedure for oral cancer

    The list of participants will be sent an initial email inviting them to view the module and complete a pre test (control group) or a post test (intervention group). Reminder emails will be sent every 2 months for up to 6 months following the initial email. It is expected that at least a 15% higher proportion of Intervention group PCPs will attain the high score category for each of this index, as compared to the Control group PCPs.

    Measured: An average of 8 months from the time of the initial email sent on 7/21/11.

Secondary outcomes (2)

  1. To determine if a change in Stage of Diagnosis of Oral Cancer occurred for the particular year of Web-based Educational Intervention.

    Three years post-web-based education intervention data will be requested from Ohio Cancer Incidence Surveillance System (OCISS). OCISS's cleaning and processing of the data takes approximately three years. Comparison using Chi-square will be carried out pre- and post- intervention years.

    Measured: 3 years

  2. Index of knowledge of risk factors for oral cancer.

    The list of participants will be sent an initial email inviting them to view the module and complete a pre test (control group) or a post test (intervention group). Reminder emails will be sent every 2 months for up to 6 months following the initial email. It is expected that at least a 15% higher proportion of Intervention group PCP's will attain the high score category for this index, as compared to the Control group PCP's.

    Measured: An average of 8 months from the time of the initial email sent on 7/21/11.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2011 (estimated)
  2. Study startJul 2011
  3. Primary completionSep 2013
  4. Study completionSep 2013

Resources

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
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01424358
Sponsor's protocol ID
11-16008
Other IDs
7K23DE016890-07
Status last verified
Dec 2012
First submitted
22 Aug 2011
Last updated
24 Mar 2015
Results posted
No
Data monitoring committee
No

Publications

  • Jemal A, Thomas A, Murray T, Thun M. Cancer statistics, 2002. CA Cancer J Clin. 2002 Jan-Feb;52(1):23-47. doi: 10.3322/canjclin.52.1.23.

    PubMed 11814064

  • Canto MT, Devesa SS. Oral cavity and pharynx cancer incidence rates in the United States, 1975-1998. Oral Oncol. 2002 Sep;38(6):610-7. doi: 10.1016/s1368-8375(01)00109-9.

    PubMed 12167440

  • Silverman S Jr. Demographics and occurrence of oral and pharyngeal cancers. The outcomes, the trends, the challenge. J Am Dent Assoc. 2001 Nov;132 Suppl:7S-11S. doi: 10.14219/jada.archive.2001.0382.

    PubMed 11803655

  • Mashberg A, Garfinkel L. Early diagnosis of oral cancer: the erythroplastic lesion in high risk sites. CA Cancer J Clin. 1978 Sep-Oct;28(5):297-303. doi: 10.3322/canjclin.28.5.297. No abstract available.

    PubMed 100189

  • Horowitz AM, Nourjah PA. Factors associated with having oral cancer examinations among US adults 40 years of age or older. J Public Health Dent. 1996 Fall;56(6):331-5. doi: 10.1111/j.1752-7325.1996.tb02460.x.

    PubMed 9089528

  • Canto MT, Drury TF, Horowitz AM. Use of skin and oral cancer examinations in the United States, 1998. Prev Med. 2003 Sep;37(3):278-82. doi: 10.1016/s0091-7435(03)00124-5.

    PubMed 12914834

  • Horowitz AM, Moon HS, Goodman HS, Yellowitz JA. Maryland adults' knowledge of oral cancer and having oral cancer examinations. J Public Health Dent. 1998 Fall;58(4):281-7. doi: 10.1111/j.1752-7325.1998.tb03010.x.

    PubMed 10390710

  • Goodman HS, Yellowitz JA, Horowitz AM. Oral cancer prevention. The role of family practitioners. Arch Fam Med. 1995 Jul;4(7):628-36. doi: 10.1001/archfami.4.7.628. No abstract available.

    PubMed 7606301

Questions about this trial

What is this clinical trial studying?

A study testing Web-based Educational Intervention in people with Oral Cancer, run by Creighton University 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 3 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 24 Mar 2015. 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. 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?

Index of knowledge of diagnostic procedure for oral cancer (time frame: An average of 8 months from the time of the initial email sent on 7/21/11.). 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 NCT01424358, which also lists 8 linked publications.

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 24 Mar 2015.

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