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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Personal Patient Profile - Prostate (P3P)
Standard prostate cancer information websites
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Prostate Cancer focused on measuring Prostate cancer, Decision

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Kaiser Permanente - Souther California
  • Kaiser Permanente - Southern California
  • Emory Healthcare
  • Beth Israel Deaconess Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Usual patient education + standard educational websites

Usual patient education + P3P decision support website

Arm Description

Outcomes

Primary Outcome Measures

Decisional conflict
O'Connor, 1995, Decisional conflict scale
Preparation for decision making
Graham and O'Connor, 1995, Preparation for decision making scale
Satisfaction with decision
Holmes-Rovner et al, 1996, Satisfaction with decision scale

Secondary Outcome Measures

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).
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 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.

Full Information

First Posted
April 26, 2013
Last Updated
January 30, 2018
Sponsor
Dana-Farber Cancer Institute
Collaborators
National Institute of Nursing Research (NINR)
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1. Study Identification

Unique Protocol Identification Number
NCT01844999
Brief Title
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

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
August 1, 2013 (Actual)
Primary Completion Date
June 30, 2016 (Actual)
Study Completion Date
June 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
National Institute of Nursing Research (NINR)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate cancer, Decision

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
392 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual patient education + standard educational websites
Arm Type
Other
Arm Title
Usual patient education + P3P decision support website
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Personal Patient Profile - Prostate (P3P)
Intervention Description
Website supporting informed patient decision making about prostate cancer care through tailored education and coaching
Intervention Type
Behavioral
Intervention Name(s)
Standard prostate cancer information websites
Intervention Description
Standard prostate cancer information websites (e.g., NCI, ASCO) presented to patients in addition to patient education that is usual in their clinics
Primary Outcome Measure Information:
Title
Decisional conflict
Description
O'Connor, 1995, Decisional conflict scale
Time Frame
Change from baseline to 6-months
Title
Preparation for decision making
Description
Graham and O'Connor, 1995, Preparation for decision making scale
Time Frame
1-month after study entry
Title
Satisfaction with decision
Description
Holmes-Rovner et al, 1996, Satisfaction with decision scale
Time Frame
6-months after study entry
Secondary Outcome Measure Information:
Title
Concordance of care choice selected with self-reported influential personal preferences
Description
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
Title
Net cost and benefit of the intervention
Description
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
Title
Time to treatment decision
Description
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donna L Berry, PhD, RN
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaiser Permanente - Souther California
City
Downey
State/Province
California
Country
United States
Facility Name
Kaiser Permanente - Southern California
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Emory Healthcare
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
36002847
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.
Results Reference
derived
PubMed Identifier
33353864
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.
Results Reference
derived
PubMed Identifier
30626400
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.
Results Reference
derived

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

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