NCT01844999

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
392

participants targeted

Target at P75+ for not_applicable prostate-cancer

Timeline
Completed

Started Aug 2013

Typical duration for not_applicable prostate-cancer

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 3, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
Last Updated

January 31, 2018

Status Verified

January 1, 2018

Enrollment Period

2.9 years

First QC Date

April 26, 2013

Last Update Submit

January 30, 2018

Conditions

Prostate Cancer

Keywords

Prostate cancerDecision

Outcome Measures

Primary Outcomes (3)

  • Decisional conflict

    O'Connor, 1995, Decisional conflict scale

    Change from baseline to 6-months

  • Preparation for decision making

    Graham and O'Connor, 1995, Preparation for decision making scale

    1-month after study entry

  • Satisfaction with decision

    Holmes-Rovner et al, 1996, Satisfaction with decision scale

    6-months after study entry

Secondary Outcomes (3)

  • Concordance of care choice selected with self-reported influential personal preferences

    6-months from study entry

  • Net cost and benefit of the intervention

    1-week after study entry

  • Time to treatment decision

    6-months from study entry

Study Arms (2)

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)

Interventions

Personal Patient Profile - Prostate (P3P)BEHAVIORAL

Website supporting informed patient decision making about prostate cancer care through tailored education and coaching

Usual patient education + P3P decision support website
Standard prostate cancer information websitesBEHAVIORAL

Standard prostate cancer information websites (e.g., NCI, ASCO) presented to patients in addition to patient education that is usual in their clinics

Usual patient education + standard educational websites

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Kaiser Permanente - Souther California

Downey, California, United States

Location

Kaiser Permanente - Southern California

Los Angeles, California, United States

Location

Emory Healthcare

Atlanta, Georgia, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

Related Publications (3)

  • 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.

    PMID: 36002847DERIVED

  • 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.

    PMID: 33353864DERIVED

  • 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.

    PMID: 30626400DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Donna L Berry, PhD, RN

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 26, 2013

First Posted

May 3, 2013

Study Start

August 1, 2013

Primary Completion

June 30, 2016

Study Completion

June 30, 2017

Last Updated

January 31, 2018

Record last verified: 2018-01

Locations

US(4)