MelanomaNCT00826995
Comparison of Video-Based Versus Written Patient Education on Melanoma
A study testing Patient Educational Materials in people with Melanoma and Malignant Melanoma, run by University of California, Davis at 1 site in United States.
Trial summary
The purpose of this study is to compare the effect of video-based patient education with written instruction on subjects' understanding of melanoma. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Melanoma, Malignant Melanoma
- What is being tested?
- Patient Educational Materials
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Jul 2009
- 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
- 18 years of age or older at time of consent, may be men or women.
- Able to adhere to the study visit schedule and other protocol requirements.
- Capable of giving informed consent.
Who cannot join
- Non-English speaking individuals.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Davis Department of Dermatology
Sacramento, California, 95816
About this study
Official title: Comparison of Video-based Versus Written Patient Education on Melanoma
The purpose of this study is to compare the effect of video-based patient education with written instruction on subjects' understanding of melanoma.
Read the detailed description
We plan to conduct a randomized, controlled trial comparing the effect of video-based patient education with written instruction on subjects' understanding of melanoma.
Subjects randomized to the video-based education arm will be instructed to watch a video on the definition of melanoma, risk factors associated with the development of melanoma, and signs that should prompt an evaluation for melanoma. Subjects randomized to the written education arm will receive written information on the definition of melanoma, risk factors associated with the development of melanoma, and signs that should prompt an evaluation for melanoma. The contents of the video and the written educational materials will be comparable.
At the end of the study period 1 month later, subjects will be interviewed via telephone regarding their understanding of melanoma. Subjects will also be interviewed regarding their comprehension and attitude towards video-based and written education materials.
- Conditions
- Melanoma, Malignant Melanoma
- Being tested
- Patient Educational Materials
- Keywords
- patient Education, dermatology Patient Education, melanoma, melanoma education, malignant melanoma, melanoma detection
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Educational MaterialsOther
Also called Patient educational materials on melanoma detection
In the experimental arm, the intervention is the video-based patient educational material on melanoma. In the active comparison arm (control arm), the comparison intervention is written patient educational material on melanoma.
| Study group | Role | What they receive |
|---|---|---|
| Video-based education arm: | Experimental | Subjects receiving the video-based educational material Receives: Other: Patient Educational Materials |
| Written education arm: | Active comparator | Subjects receiving the written educational material Receives: Other: Patient Educational Materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge of melanoma detection.
Measured: 1 month
Secondary outcomes (1)
Subjects' comprehension and attitude towards video-based and written education materials.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionMay 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- April W Armstrong, MD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00826995
- Sponsor's protocol ID
- 200816692-1
- Status last verified
- Apr 2015
- First submitted
- 20 Jan 2009
- Last updated
- 22 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Video-based Versus Written Patient Education on Melanoma
- ClinicalTrials.gov ID
- NCT00826995
- Acronym / sponsor ID
- 200816692-1
- Conditions
- Melanoma, Malignant Melanoma
- Keywords
- patient Education, dermatology Patient Education, melanoma, melanoma education, malignant melanoma, melanoma detection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- May 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 22 Jan 2009 (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.
The purpose of this study is to compare the effect of video-based patient education with written instruction on subjects' understanding of melanoma.
Detailed description
We plan to conduct a randomized, controlled trial comparing the effect of video-based patient education with written instruction on subjects' understanding of melanoma.
Subjects randomized to the video-based education arm will be instructed to watch a video on the definition of melanoma, risk factors associated with the development of melanoma, and signs that should prompt an evaluation for melanoma. Subjects randomized to the written education arm will receive written information on the definition of melanoma, risk factors associated with the development of melanoma, and signs that should prompt an evaluation for melanoma. The contents of the video and the written educational materials will be comparable.
At the end of the study period 1 month later, subjects will be interviewed via telephone regarding their understanding of melanoma. Subjects will also be interviewed regarding their comprehension and attitude towards video-based and written education materials.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video-based education arm: | Experimental | Other: Patient Educational MaterialsSubjects receiving the video-based educational material |
| Written education arm: | Active comparator | Other: Patient Educational MaterialsSubjects receiving the written educational material |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age or older at time of consent, may be men or women.
- Able to adhere to the study visit schedule and other protocol requirements.
- Capable of giving informed consent.
Key exclusion criteria (1 listed)
- Non-English speaking individuals.
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 |
|---|---|---|
| Patient Educational MaterialsAlso: Patient educational materials on melanoma detectionIn the experimental arm, the intervention is the video-based patient educational material on melanoma. In the active comparison arm (control arm), the comparison intervention is written patient educational material on melanoma. | Other | Video-based education arm:, Written education arm: |
Primary outcome
Knowledge of melanoma detection.
Time frame: 1 month
1 secondary outcome
Subjects' comprehension and attitude towards video-based and written education materials.
Time frame: 1 month
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 Apr 2015.
- University of California-Davis Department of Dermatology Clinical ResearchLink provided by the sponsor.
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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.
April W Armstrong, MD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Educational Materials in people with Melanoma and Malignant Melanoma, run by University of California, Davis 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 22 Apr 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?
Knowledge of melanoma detection. (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Apr 2015.