CClinicalTrials.gg
CompletedNCT01844999Updated Jan 31, 2018

Personal Patient Profile - Prostate (P3P) II: Effectiveness-Implementation Trial in Diverse Health Care Networks

An interventional study of Personal Patient Profile - Prostate (P3P) and Standard prostate cancer information websites in Prostate Cancer, sponsored by Dana-Farber Cancer Institute. Completed at 4 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-01-31.

Sponsored by Dana-Farber Cancer Institute · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
392
Allocation
Randomized
Ages
18 Years and older
Sex
Male
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Study 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.

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Conditions studied

  • Prostate Cancer

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Keywords

  • Prostate cancer
  • Decision
03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's enrollment of 392 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Dana-Farber Cancer Institute is the lead sponsor of 813 studies on the registry; 124 are open to participants now.

Of its 113 completed or terminated interventional studies of FDA-regulated products, 77 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

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

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
392 participants (actual)

Study arms

  • Other
    Usual patient education + standard educational websites

    Behavioral: Standard prostate cancer information websites

  • Experimental
    Usual patient education + P3P decision support website

    Behavioral: Personal Patient Profile - Prostate (P3P)

Interventions

  • BehavioralPersonal Patient Profile - Prostate (P3P)

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

  • BehavioralStandard prostate cancer information websites

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

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What researchers measure

Primary outcomes

  1. Decisional conflict

    O'Connor, 1995, Decisional conflict scale

    Time frame: Change from baseline to 6-months

  2. Preparation for decision making

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

    Time frame: 1-month after study entry

  3. Satisfaction with decision

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

    Time frame: 6-months after study entry

Secondary outcomes

  1. 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).

    Time frame: 6-months from study entry

  2. 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.

    Time frame: 1-week after study entry

  3. 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.

    Time frame: 6-months from study entry

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Study locations

4 sites
  • Kaiser Permanente - Souther California
    Downey, California, United States
  • Kaiser Permanente - Southern California
    Los Angeles, California, United States
  • Emory Healthcare
    Atlanta, Georgia, United States
  • Beth Israel Deaconess Medical Center
    Boston, Massachusetts 02115, United States
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References and documents

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 36002847 ↗
  • 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. PubMed 33353864 ↗
  • 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. PubMed 30626400 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 31, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01844999
Lead sponsor
Dana-Farber Cancer Institute
Collaborators
National Institute of Nursing Research (NINR)
Responsible party
Donna Berry, PhD, RN, FAAN, ACON (Principal Investigator, Dana-Farber Cancer Institute) — Principal investigator
First posted
May 3, 2013
Start date
Aug 1, 2013
Primary completion
Jun 30, 2016
Completion
Jun 30, 2017
Last update
Jan 31, 2018

Study contacts

Donna L Berry, PhD, RN
principal investigator · Dana-Farber Cancer Institute

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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