Prostate CancerNCT00013247
Facilitating Shared Decisionmaking About Prostate Cancer Screening
A study testing Prostate Cancer Screening Education in people with Prostate Cancer, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
Due to the disputed efficacy of prostate cancer (CaP) screening and treatment, most authorities recommend that providers inform and involve patients in CaP screening decisions. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Prostate Cancer Screening Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,152 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Dec 2002
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be male veterans, age 50 and older, with a scheduled primary care appointment at one of 5 VISN 13 medical facilities. Patients diagnosed with prostate cancer will be excluded.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, 55417
About this study
Due to the disputed efficacy of prostate cancer (CaP) screening and treatment, most authorities recommend that providers inform and involve patients in CaP screening decisions.
Read the detailed description
Background:
Due to the disputed efficacy of prostate cancer (CaP) screening and treatment, most authorities recommend that providers inform and involve patients in CaP screening decisions.
Objectives:
This study evaluated two interventions designed to facilitate this process.
Methods:
1152 male veterans age 50+ with no CaP and primary care appointments at four VA medical facilities in VISN 23 were randomly assigned to one of three groups: mailed pamphlet intervention, mailed video intervention, or usual care (control). Intervention materials were mailed two weeks prior to a target primary care appointment and patient telephone surveys were conducted one week (T1) and one year (T2) after the target appointment. Outcomes included: a 10- item validated knowledge index; responses to questions on CaP natural history, treatment efficacy, PSA accuracy, and expert disagreement about the PSA; whether screening was discussed with provider; scores on decision information seeking, participation and satisfaction scales; screening and treatment preferences; and PSA testing rates.
Status:
Complete
- Conditions
- Prostate Cancer
- Being tested
- Prostate Cancer Screening Education
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prostate Cancer Screening EducationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | Not described Receives: Behavioral: Prostate Cancer Screening Education |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2001 (estimated)
- Study completionDec 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 1,152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Melissa R. Partin, PhD, Principal investigator, Minneapolis VA Health Care System, Minneapolis, MN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00013247
- Sponsor's protocol ID
- IIR 99-277
- Status last verified
- Feb 2007
- First submitted
- 14 Mar 2001
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Partin MR, Nelson D, Flood AB, Friedemann-Sanchez G, Wilt TJ. Who uses decision aids? Subgroup analyses from a randomized controlled effectiveness trial of two prostate cancer screening decision support interventions. Health Expect. 2006 Sep;9(3):285-95. doi: 10.1111/j.1369-7625.2006.00400.x.
PubMed 16911143Radosevich DM, Partin MR, Nugent S, Nelson D, Flood AB, Holtzman J, Dillon N, Haas M, Wilt TJ. Measuring patient knowledge of the risks and benefits of prostate cancer screening. Patient Educ Couns. 2004 Aug;54(2):143-52. doi: 10.1016/S0738-3991(03)00207-6.
PubMed 15288907Wilt TJ, Partin MR. Reducing PSAnxiety: The importance of noninvasive chronic disease management in prostate cancer detection and treatment. Am J Med. 2004 Nov 15;117(10):796-8. doi: 10.1016/j.amjmed.2004.10.002. No abstract available.
PubMed 15541329Wilt TJ, Partin MR. Prostate cancer intervention. Involving the patient in early detection and treatment. Postgrad Med. 2003 Oct;114(4):43-9; quiz 50. doi: 10.3810/pgm.2003.10.1506.
PubMed 14587206Partin MR, Nelson D, Radosevich D, Nugent S, Flood AB, Dillon N, Holtzman J, Haas M, Wilt TJ. Randomized trial examining the effect of two prostate cancer screening educational interventions on patient knowledge, preferences, and behaviors. J Gen Intern Med. 2004 Aug;19(8):835-42. doi: 10.1111/j.1525-1497.2004.30047.x.
PubMed 15242468Taylor BC, Wilt TJ, Clothier B, Grill JP, Partin MR. Assessing health status in older men with lower urinary tract symptoms. Federal practitioner : for the health care professionals of the VA, DoD, and PHS. 2006 Jul 1; 23(7):29-40.
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facilitating Shared Decisionmaking About Prostate Cancer Screening
- ClinicalTrials.gov ID
- NCT00013247
- Acronym / sponsor ID
- IIR 99-277
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,152 participants (estimated)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study completion
- Dec 2002 (actual)
- First posted
- 16 Mar 2001 (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.
Due to the disputed efficacy of prostate cancer (CaP) screening and treatment, most authorities recommend that providers inform and involve patients in CaP screening decisions.
Detailed description
Background:
Due to the disputed efficacy of prostate cancer (CaP) screening and treatment, most authorities recommend that providers inform and involve patients in CaP screening decisions.
Objectives:
This study evaluated two interventions designed to facilitate this process.
Methods:
1152 male veterans age 50+ with no CaP and primary care appointments at four VA medical facilities in VISN 23 were randomly assigned to one of three groups: mailed pamphlet intervention, mailed video intervention, or usual care (control). Intervention materials were mailed two weeks prior to a target primary care appointment and patient telephone surveys were conducted one week (T1) and one year (T2) after the target appointment. Outcomes included: a 10- item validated knowledge index; responses to questions on CaP natural history, treatment efficacy, PSA accuracy, and expert disagreement about the PSA; whether screening was discussed with provider; scores on decision information seeking, participation and satisfaction scales; screening and treatment preferences; and PSA testing rates.
Status:
Complete
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Behavioral: Prostate Cancer Screening Education |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients must be male veterans, age 50 and older, with a scheduled primary care appointment at one of 5 VISN 13 medical facilities. Patients diagnosed with prostate cancer will be excluded.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Prostate Cancer Screening Education | Behavioural | Arm 1 |
Primary outcome
Not reported in the source record.
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 7 Apr 2015.
- Results publication: PubMed 16911143Partin MR, Nelson D, Flood AB, Friedemann-Sanchez G, Wilt TJ. Who uses decision aids? Subgroup analyses from a randomized controlled effectiveness trial of two prostate cancer screening decision support interventions. Health Expect. 2006 Sep;9(3):285-95. doi: 10.1111/j.1369-7625.2006.00400.x.
- Results publication: PubMed 15288907Radosevich DM, Partin MR, Nugent S, Nelson D, Flood AB, Holtzman J, Dillon N, Haas M, Wilt TJ. Measuring patient knowledge of the risks and benefits of prostate cancer screening. Patient Educ Couns. 2004 Aug;54(2):143-52. doi: 10.1016/S0738-3991(03)00207-6.
- Results publication: PubMed 15541329Wilt TJ, Partin MR. Reducing PSAnxiety: The importance of noninvasive chronic disease management in prostate cancer detection and treatment. Am J Med. 2004 Nov 15;117(10):796-8. doi: 10.1016/j.amjmed.2004.10.002. No abstract available.
- Results publication: PubMed 14587206Wilt TJ, Partin MR. Prostate cancer intervention. Involving the patient in early detection and treatment. Postgrad Med. 2003 Oct;114(4):43-9; quiz 50. doi: 10.3810/pgm.2003.10.1506.
- Results publication: PubMed 15242468Partin MR, Nelson D, Radosevich D, Nugent S, Flood AB, Dillon N, Holtzman J, Haas M, Wilt TJ. Randomized trial examining the effect of two prostate cancer screening educational interventions on patient knowledge, preferences, and behaviors. J Gen Intern Med. 2004 Aug;19(8):835-42. doi: 10.1111/j.1525-1497.2004.30047.x.
- Results publicationTaylor BC, Wilt TJ, Clothier B, Grill JP, Partin MR. Assessing health status in older men with lower urinary tract symptoms. Federal practitioner : for the health care professionals of the VA, DoD, and PHS. 2006 Jul 1; 23(7):29-40.
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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.
Melissa R. Partin, PhD principal investigator
Minneapolis VA Health Care System, Minneapolis, MN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prostate Cancer Screening Education in people with Prostate Cancer, run by US Department of Veterans Affairs 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 1 inclusion and 0 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 7 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00013247, which also lists 6 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 7 Apr 2015.