Clinical trial NCT01844999: Personal Patient Profile - Prostate (P3P) II: Effectiveness-Implementation Trial in Diverse Health Care Networks
Official title: Personal Patient Profile - Prostate (P3P) II: Effectiveness-Implementation Trial in Diverse Health Care Networks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate cancer
Decision
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2013-05-03
Enrollment: 392
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Two or more post-biopsy specialist consults
* Begun treatment (or active surveillance)

Primary outcomes:
measure: Decisional conflict
timeFrame: Change from baseline to 6-months
measure: Preparation for decision making
timeFrame: 1-month after study entry
measure: Satisfaction with decision
timeFrame: 6-months after study entry
Secondary outcomes:
measure: Concordance of care choice selected with self-reported influential personal preferences
timeFrame: 6-months from study entry
measure: Net cost and benefit of the intervention
timeFrame: 1-week after study entry
measure: Time to treatment decision
timeFrame: 6-months from study entry
Other outcomes:
Locations:
city: Downey
country: United States
facility: Kaiser Permanente - Souther California
state: California
city: Los Angeles
country: United States
facility: Kaiser Permanente - Southern California
state: California
city: Atlanta
country: United States
facility: Emory Healthcare
state: Georgia
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Donna L Berry, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Berry 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.
citation: Wilson 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.