Prostate CancerNCT01844999
Personal Patient Profile - Prostate (P3P) II: Effectiveness-Implementation Trial in Diverse Health Care Networks
A study testing Personal Patient Profile - Prostate (P3P) and Standard prostate cancer information websites in people with Prostate Cancer, run by Dana-Farber Cancer Institute at 4 sites in United States.
Trial summary
The purpose of this study is to determine whether using the P3P website can increase decisional preparation and satisfaction, and decrease decisional conflict, in men deciding how to manage early stage prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Personal Patient Profile - Prostate (P3P) and Standard prostate cancer information websites
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 392 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Aug 2013to 30 Jun 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy-proven diagnosis of prostate cancer, T1 or T2 of any risk level
- Biopsy done at enrolling site
- Upcoming appointment with consulting specialist at enrolling study site
- Able to read, write, understand English
Who cannot join
- Two or more post-biopsy specialist consults
- Begun treatment (or active surveillance)
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Emory Healthcare
Atlanta, Georgia
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
Kaiser Permanente - Souther California
Downey, California
Kaiser Permanente - Southern California
Los Angeles, California
About this study
The purpose of this study is to determine whether using the P3P website can increase decisional preparation and satisfaction, and decrease decisional conflict, in men deciding how to manage early stage prostate cancer.
- Conditions
- Prostate Cancer
- Being tested
- Personal Patient Profile - Prostate (P3P), Standard prostate cancer information websites
- Keywords
- Prostate cancer, Decision
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personal Patient Profile - Prostate (P3P)Behavioural
Website supporting informed patient decision making about prostate cancer care through tailored education and coaching
Standard prostate cancer information websitesBehavioural
Standard prostate cancer information websites (e.g., NCI, ASCO) presented to patients in addition to patient education that is usual in their clinics
| Study group | Role | What they receive |
|---|---|---|
| Usual patient education + standard educational websites | Other | Not described Receives: Behavioral: Standard prostate cancer information websites |
| Usual patient education + P3P decision support website | Experimental | Not described Receives: Behavioral: Personal Patient Profile - Prostate (P3P) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decisional conflict
O'Connor, 1995, Decisional conflict scale
Measured: Change from baseline to 6-months
Preparation for decision making
Graham and O'Connor, 1995, Preparation for decision making scale
Measured: 1-month after study entry
Satisfaction with decision
Holmes-Rovner et al, 1996, Satisfaction with decision scale
Measured: 6-months after study entry
Secondary outcomes (3)
Concordance of care choice selected with self-reported influential personal preferences
Odds ratio of selecting a care option for prostate cancer concordant with avoiding prioritized side effects (XBRT or brachytherapy if concerned with sexual function; prostatectomy if concerned with bowel function; active surveillance if concerned with sexual, bowel, and/or bladder function; any treatment if not concerned with any side effect).
Measured: 6-months from study entry
Net cost and benefit of the intervention
Cost to the patient will be measured in hours valued according to patient work status, income, and use of time. Benefit will be measured with Willingness to pay.
Measured: 1-week after study entry
Time to treatment decision
Duration (in days) from pre-decision baseline questionnaire until patient decides on a care option for prostate cancer, either an active treatment type or active surveillance. Measured by patient recall at 6-months.
Measured: 6-months from study entry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2013 (estimated)
- Study start1 Aug 2013
- Primary completion30 Jun 2016
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 392 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Donna Berry, PhD, RN, FAAN, ACON, Dana-Farber Cancer Institute
- Investigators
- Donna L Berry, PhD, RN, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01844999
- Sponsor's protocol ID
- 12-363
- Other IDs
- 2R01NR009692-05
- Status last verified
- Jan 2018
- First submitted
- 26 Apr 2013
- Last updated
- 31 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Pozzar RA, Xiong N, Hong F, Filson CP, Chang P, Halpenny B, Berry DL. Concordance between influential adverse treatment outcomes and localized prostate cancer treatment decisions. BMC Med Inform Decis Mak. 2022 Aug 24;22(1):223. doi: 10.1186/s12911-022-01972-w.
PubMed 36002847Berry DL, Hong F, Blonquist TM, Halpenny B, Xiong N, Filson CP, Master VA, Sanda MG, Chang P, Chien GW, Jones RA, Krupski TL, Wolpin S, Wilson L, Hayes JH, Trinh QD, Sokoloff M. Decision regret, adverse outcomes, and treatment choice in men with localized prostate cancer: Results from a multi-site randomized trial. Urol Oncol. 2021 Aug;39(8):493.e9-493.e15. doi: 10.1016/j.urolonc.2020.11.038. Epub 2021 Jan 19.
PubMed 33353864Wilson LS, Blonquist TM, Hong F, Halpenny B, Wolpin S, Chang P, Filson CP, Master VA, Sanda MG, Chien GW, Jones RA, Krupski TL, Berry DL. Assigning value to preparation for prostate cancer decision making: a willingness to pay analysis. BMC Med Inform Decis Mak. 2019 Jan 9;19(1):6. doi: 10.1186/s12911-018-0725-4.
PubMed 30626400
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personal Patient Profile - Prostate (P3P) II: Effectiveness-Implementation Trial in Diverse Health Care Networks
- ClinicalTrials.gov ID
- NCT01844999
- Acronym / sponsor ID
- 12-363
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer, Decision
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 392 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 1 Aug 2013 (actual)
- Primary completion
- 30 Jun 2016 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 3 May 2013 (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 determine whether using the P3P website can increase decisional preparation and satisfaction, and decrease decisional conflict, in men deciding how to manage early stage prostate cancer.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual patient education + standard educational websites | Other | Behavioral: Standard prostate cancer information websites |
| Usual patient education + P3P decision support website | Experimental | Behavioral: Personal Patient Profile - Prostate (P3P) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Biopsy-proven diagnosis of prostate cancer, T1 or T2 of any risk level
- Biopsy done at enrolling site
- Upcoming appointment with consulting specialist at enrolling study site
- Able to read, write, understand English
Key exclusion criteria (2 listed)
- Two or more post-biopsy specialist consults
- Begun treatment (or active surveillance)
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 |
|---|---|---|
| Personal Patient Profile - Prostate (P3P)Website supporting informed patient decision making about prostate cancer care through tailored education and coaching | Behavioural | Usual patient education + P3P decision support website |
| Standard prostate cancer information websitesStandard prostate cancer information websites (e.g., NCI, ASCO) presented to patients in addition to patient education that is usual in their clinics | Behavioural | Usual patient education + standard educational websites |
Primary outcome
Decisional conflict
Time frame: Change from baseline to 6-months
O'Connor, 1995, Decisional conflict scale
Preparation for decision making
Time frame: 1-month after study entry
Graham and O'Connor, 1995, Preparation for decision making scale
Satisfaction with decision
Time frame: 6-months after study entry
Holmes-Rovner et al, 1996, Satisfaction with decision scale
3 secondary outcomes
Concordance of care choice selected with self-reported influential personal preferences
Time frame: 6-months from study entry
Net cost and benefit of the intervention
Time frame: 1-week after study entry
Time to treatment decision
Time frame: 6-months from study entry
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 31 Jan 2018.
- Derived from this study: PubMed 36002847Pozzar RA, Xiong N, Hong F, Filson CP, Chang P, Halpenny B, Berry DL. Concordance between influential adverse treatment outcomes and localized prostate cancer treatment decisions. BMC Med Inform Decis Mak. 2022 Aug 24;22(1):223. doi: 10.1186/s12911-022-01972-w.
- Derived from this study: PubMed 33353864Berry DL, Hong F, Blonquist TM, Halpenny B, Xiong N, Filson CP, Master VA, Sanda MG, Chang P, Chien GW, Jones RA, Krupski TL, Wolpin S, Wilson L, Hayes JH, Trinh QD, Sokoloff M. Decision regret, adverse outcomes, and treatment choice in men with localized prostate cancer: Results from a multi-site randomized trial. Urol Oncol. 2021 Aug;39(8):493.e9-493.e15. doi: 10.1016/j.urolonc.2020.11.038. Epub 2021 Jan 19.
- Derived from this study: PubMed 30626400Wilson LS, Blonquist TM, Hong F, Halpenny B, Wolpin S, Chang P, Filson CP, Master VA, Sanda MG, Chien GW, Jones RA, Krupski TL, Berry DL. Assigning value to preparation for prostate cancer decision making: a willingness to pay analysis. BMC Med Inform Decis Mak. 2019 Jan 9;19(1):6. doi: 10.1186/s12911-018-0725-4.
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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.
Donna L Berry, PhD, RN principal investigator
Dana-Farber Cancer Institute
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personal Patient Profile - Prostate (P3P) and Standard prostate cancer information websites in people with Prostate Cancer, run by Dana-Farber Cancer Institute at 4 sites 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 4 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 31 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 4 sites 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?
Decisional conflict (time frame: Change from baseline to 6-months). The study lists 3 primary outcomes in all. 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 NCT01844999, which also lists 3 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 31 Jan 2018.