Adenocarcinoma of ProstateNCT02342626
Devel. and Eval. of an Active Surveillance Decision Aid for Men With Low or Intermediate Grade Prostate Cancer
A study testing Dashboard in people with Adenocarcinoma of Prostate, run by University of Rochester at 1 site in United States.
Trial summary
The overall goal of this project is to test an interactive, multi-media decision aid in the form of an electronic clinical decision dashboard designed to improve the quality of clinical decision making for initial treatment of patients with newly diagnosed, low or intermediate risk prostate cancer. Read more about this study
- Who is it for?
- Ages 40 to 85 years, men only
- Conditions the study is for
- Adenocarcinoma of Prostate
- What is being tested?
- Dashboard
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Dec 2017
- 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 40 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 40 to 85 years
- Sex: male
- Race/ethnicity: no restrictions
- Diagnosis: Patients will be eligible for the study if they have not yet decided on a management plan and present with either:
- localized, low grade prostate cancer, defined as Gleason score ≤ 6, T1-T2a stage cancers, and PSA values < 10 ng/ml, OR
- Intermediate risk prostate cancer, defined as Gleason score = 7, T2b-T2c stage cancers (these tumors involve more of the prostate but do not extend beyond the prostatic capsule), or PSA 10-20 ng/ml
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- Willing to participate and able to give informed consent
- Able to adequately see the study intervention which is an interactive decision dashboard \& complete study-related questionnaires
- Able to understand English language adequately to use the decision dashboard and complete study-related questionnaires
Who cannot join
- Unable to complete study-related tasks due to cognitive deficits or English non-fluency
- Unwilling to participate.
- Deemed clinically unsuitable for active surveillance as a prostate cancer management option
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: CDC SIP: Rochester Prevention Research Center: Development and Evaluation of an Active Surveillance Decision Aid for Men With Low or Intermediate Grade Prostate Cancer
The overall goal of this project is to test an interactive, multi-media decision aid in the form of an electronic clinical decision dashboard designed to improve the quality of clinical decision making for initial treatment of patients with newly diagnosed, low or intermediate risk prostate cancer.
Read the detailed description
The overall goal of this project is to test an interactive, multi-media decision aid in the form of an electronic clinical decision dashboard designed to improve the quality of clinical decision making for initial treatment of patients with newly diagnosed, low or intermediate risk prostate cancer.
Specifically, we propose to conduct a clinical trial to compare the effects of a prostate decision dashboard versus usual care on:
- patient knowledge regarding the treatment options available for low or intermediate risk prostate cancer,
- measures of the decision making process including decisional conflict and the extent to which decisions were made via a shared decision making process,
- the treatments selected, and
- 3-6 and 9-12 month outcome assessments of clinical status, decision regret, cancer-related quality of life including worry, functional status, and treatment side effects.
- Conditions
- Adenocarcinoma of Prostate
- Being tested
- Dashboard
- Keywords
- Prostate, Cancer, Adenocarcinoma
- Medical subject headings
- Neoplasms, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DashboardBehavioural
With the health care provider, subjects will use the decision dashboard to augment the discussion of treatment options.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No use of the decision aid dashboard before, during or after the treatment decision time period. |
| Dashboard | Experimental | Use of the decision aid dashboard before, during and after the treatment decision time period. Receives: Behavioral: Dashboard |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in KUJ score through education
The use of the dashboard will increase patient knowledge and understanding of treatment options as measured using KUJ questionnaire.
Measured: 2 years
Secondary outcomes (1)
Measure of overall quality and satisfaction with initial treatment decision.
The use of the dashboard will improve the overall quality and satisfaction with initial treatment decisions as measured by a) decisional conflict, b) patient quality of life, and c) post-decision regret, using the PORPUS questionnaire and Decisional Regret questionnaire.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionNov 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarcinoma of ProstateStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Dolan, University of Rochester
- Investigators
- James G Dolan, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02342626
- Sponsor's protocol ID
- UCCS14115
- Status last verified
- Jan 2018
- First submitted
- 15 Jan 2015
- Last updated
- 9 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CDC SIP: Rochester Prevention Research Center: Development and Evaluation of an Active Surveillance Decision Aid for Men With Low or Intermediate Grade Prostate Cancer
- ClinicalTrials.gov ID
- NCT02342626
- Acronym / sponsor ID
- UCCS14115
- Conditions
- Adenocarcinoma of Prostate
- Keywords
- Prostate, Cancer, Adenocarcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 21 Jan 2015 (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 overall goal of this project is to test an interactive, multi-media decision aid in the form of an electronic clinical decision dashboard designed to improve the quality of clinical decision making for initial treatment of patients with newly diagnosed, low or intermediate risk prostate cancer.
Detailed description
The overall goal of this project is to test an interactive, multi-media decision aid in the form of an electronic clinical decision dashboard designed to improve the quality of clinical decision making for initial treatment of patients with newly diagnosed, low or intermediate risk prostate cancer.
Specifically, we propose to conduct a clinical trial to compare the effects of a prostate decision dashboard versus usual care on:
- patient knowledge regarding the treatment options available for low or intermediate risk prostate cancer,
- measures of the decision making process including decisional conflict and the extent to which decisions were made via a shared decision making process,
- the treatments selected, and
- 3-6 and 9-12 month outcome assessments of clinical status, decision regret, cancer-related quality of life including worry, functional status, and treatment side effects.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No use of the decision aid dashboard before, during or after the treatment decision time period. |
| Dashboard | Experimental | Behavioral: DashboardUse of the decision aid dashboard before, during and after the treatment decision time period. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age: 40 to 85 years
- Sex: male
- Race/ethnicity: no restrictions
- Diagnosis: Patients will be eligible for the study if they have not yet decided on a management plan and present with either:
- localized, low grade prostate cancer, defined as Gleason score ≤ 6, T1-T2a stage cancers, and PSA values < 10 ng/ml, OR
Key exclusion criteria (3 listed)
- Unable to complete study-related tasks due to cognitive deficits or English non-fluency
- Unwilling to participate.
- Deemed clinically unsuitable for active surveillance as a prostate cancer management option
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 |
|---|---|---|
| DashboardWith the health care provider, subjects will use the decision dashboard to augment the discussion of treatment options. | Behavioural | Dashboard |
Primary outcome
Increase in KUJ score through education
Time frame: 2 years
The use of the dashboard will increase patient knowledge and understanding of treatment options as measured using KUJ questionnaire.
1 secondary outcome
Measure of overall quality and satisfaction with initial treatment decision.
Time frame: 2 years
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 9 Jan 2018.
- Individual participant dataSharing planned: No
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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.
James G Dolan principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dashboard in people with Adenocarcinoma of Prostate, run by University of Rochester 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 9 inclusion and 3 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 9 Jan 2018. 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?
Increase in KUJ score through education (time frame: 2 years). 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 9 Jan 2018.