Stage I Prostate CancerNCT02846870
Visually Enhanced Education About Prostate Cancer
A study testing Visually enhanced prostate cancer educational presentation and Standard prostate cancer education presentation in people with Stage I Prostate Cancer and Stage II Prostate Cancer, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.
Trial summary
This randomized clinical trial studies how well visually enhanced education works in improving prostate cancer and treatment knowledge in patients with prostate cancer that has not spread to other places in the body. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Stage I Prostate Cancer, Stage II Prostate Cancer, Stage III Prostate Cancer
- What is being tested?
- Visually enhanced prostate cancer educational presentation and Standard prostate cancer education presentation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to Aug 2018
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient must have non-metastatic, biopsy proven prostate cancer
- Must be referred to radiation oncology clinic
Who cannot join
- Prior surgery or radiation therapy for prostate cancer
- Patients who are blind are excluded
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37203
About this study
Official title: Visually Enhanced Education About Prostate Cancer (VEEP-C): A Randomized Controlled Trial
This randomized clinical trial studies how well visually enhanced education works in improving prostate cancer and treatment knowledge in patients with prostate cancer that has not spread to other places in the body. Visually enhanced education includes pictures, drawings, and photos, may help doctors better convey information about radiation and prostate cancer to patients.
Read the detailed description
PRIMARY OBJECTIVES:
- Our goal is to conduct a randomized controlled trial to determine the impact of a visual presentation in the context of a radiation oncologist's discussion with patient during consultation on patient satisfaction at end of consultation visit and at end of treatment, on anxiety at start of treatment, on decision regret following treatment, and on perception of side effects following treatment. Of note, the attending radiation oncologist will be responsible for reviewing the Powerpoint presentation with the patient, taking time to answer any questions that the patient has
OUTLINE: Patients are randomized into 1 of 2 arms.
ARM A (STANDARD EDUCATION): Patients receive a standard prostate cancer radiation oncology consultation.
ARM B (VISUAL ENHANCED EDUCATION): Patients receive a visually enhanced prostate cancer educational Powerpoint presentation including prostate anatomy, pathologic results, surgical options, radiation therapy, and prognosis with pictographs during radiation oncology consultation.
- Being tested
- Visually enhanced prostate cancer educational presentation, Standard prostate cancer education presentation
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visually enhanced prostate cancer educational presentationOther
Receive visually enhanced prostate cancer educational presentation
Standard prostate cancer education presentationOther
Receive standard prostate cancer education presentation
| Study group | Role | What they receive |
|---|---|---|
| Standard Education | Active comparator | Patients receive standard-of-care prostate cancer radiation oncology consultation. Receives: Other: Standard prostate cancer education presentation |
| Visually Enhanced Education | Experimental | Patients receive a visually enhanced prostate cancer educational Powerpoint presentation including prostate anatomy, pathologic results, surgical options, radiation therapy, and prognosis with pictographs during radiation oncology consultation. Receives: Other: Visually enhanced prostate cancer educational presentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decision-Regret - based on Ottawa scale
Sample size was determined based on this primary outcome - with estimated mean of 16 in Arm A and mean of 8 in Arm B, with standard deviation of 15, with 80% power and alpha of 0.05.
Measured: Up to 12 weeks
Secondary outcomes (3)
Satisfaction - SCA
Measured: baseline, end of treatment, and long-term follow-up
Symptoms based on EPIC-26 short form
Measured: baseline, end of treatment, and long-term follow-up
Anxiety - Memorial MAX-PC scale
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2016 (estimated)
- Study startSep 2016
- Primary completionAug 2017
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage I Prostate CancerStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Austin Kirschner, Vanderbilt-Ingram Cancer Center
- Investigators
- Austin Kirschner, MD, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02846870
- Sponsor's protocol ID
- VICC RAD 1646
- Other IDs
- NCI-2016-00777
- Status last verified
- Jul 2020
- First submitted
- 25 Jul 2016
- Last updated
- 23 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visually Enhanced Education About Prostate Cancer (VEEP-C): A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02846870
- Acronym / sponsor ID
- VICC RAD 1646
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2016
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 27 Jul 2016 (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 randomized clinical trial studies how well visually enhanced education works in improving prostate cancer and treatment knowledge in patients with prostate cancer that has not spread to other places in the body. Visually enhanced education includes pictures, drawings, and photos, may help doctors better convey information about radiation and prostate cancer to patients.
Detailed description
PRIMARY OBJECTIVES:
- Our goal is to conduct a randomized controlled trial to determine the impact of a visual presentation in the context of a radiation oncologist's discussion with patient during consultation on patient satisfaction at end of consultation visit and at end of treatment, on anxiety at start of treatment, on decision regret following treatment, and on perception of side effects following treatment. Of note, the attending radiation oncologist will be responsible for reviewing the Powerpoint presentation with the patient, taking time to answer any questions that the patient has
OUTLINE: Patients are randomized into 1 of 2 arms.
ARM A (STANDARD EDUCATION): Patients receive a standard prostate cancer radiation oncology consultation.
ARM B (VISUAL ENHANCED EDUCATION): Patients receive a visually enhanced prostate cancer educational Powerpoint presentation including prostate anatomy, pathologic results, surgical options, radiation therapy, and prognosis with pictographs during radiation oncology consultation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Education | Active comparator | Other: Standard prostate cancer education presentationPatients receive standard-of-care prostate cancer radiation oncology consultation. |
| Visually Enhanced Education | Experimental | Other: Visually enhanced prostate cancer educational presentationPatients receive a visually enhanced prostate cancer educational Powerpoint presentation including prostate anatomy, pathologic results, surgical options, radiation therapy, and prognosis with pictographs during radiation oncology consultation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient must have non-metastatic, biopsy proven prostate cancer
- Must be referred to radiation oncology clinic
Key exclusion criteria (2 listed)
- Prior surgery or radiation therapy for prostate cancer
- Patients who are blind are excluded
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 |
|---|---|---|
| Visually enhanced prostate cancer educational presentationReceive visually enhanced prostate cancer educational presentation | Other | Visually Enhanced Education |
| Standard prostate cancer education presentationReceive standard prostate cancer education presentation | Other | Standard Education |
Primary outcome
Decision-Regret - based on Ottawa scale
Time frame: Up to 12 weeks
Sample size was determined based on this primary outcome - with estimated mean of 16 in Arm A and mean of 8 in Arm B, with standard deviation of 15, with 80% power and alpha of 0.05.
3 secondary outcomes
Satisfaction - SCA
Time frame: baseline, end of treatment, and long-term follow-up
Symptoms based on EPIC-26 short form
Time frame: baseline, end of treatment, and long-term follow-up
Anxiety - Memorial MAX-PC scale
Time frame: 1 week
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 23 Jul 2020.
- Individual participant dataSharing planned: Undecided
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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.
Austin Kirschner, MD principal investigator
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visually enhanced prostate cancer educational presentation and Standard prostate cancer education presentation in people with Stage I Prostate Cancer and Stage II Prostate Cancer, run by Vanderbilt-Ingram Cancer Center 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 2 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 23 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 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?
Decision-Regret - based on Ottawa scale (time frame: Up to 12 weeks). 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 23 Jul 2020.