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

Conditions

Prostate Cancer

Keywords

Prostate cancer, Decision

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.

Pozzar RA, Xiong N, Hong F, Filson CP, Chang P, Halpenny B, Berry DL.

2022-08-242 citations

10.1186/s12911-022-01972-w

Decision regret, adverse outcomes, and treatment choice in men with localized prostate cancer: Results from a multi-site randomized trial.

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.

2021-01-1918 citations

10.1016/j.urolonc.2020.11.038

Assigning value to preparation for prostate cancer decision making: a willingness to pay analysis

Leslie Wilson, Traci M. Blonquist, Fangxin Hong, Barbara Halpenny, Seth Wolpin et al. (13 authors)

BMC Medical Informatics and Decision Making2019-01-0911 citations

10.1186/s12911-018-0725-4

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

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

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

Design outcomes

Primary

Measure	Time frame	Description
Decisional conflict	Change from baseline to 6-months	O'Connor, 1995, Decisional conflict scale
Preparation for decision making	1-month after study entry	Graham and O'Connor, 1995, Preparation for decision making scale
Satisfaction with decision	6-months after study entry	Holmes-Rovner et al, 1996, Satisfaction with decision scale

Secondary

Measure	Time frame	Description
Concordance of care choice selected with self-reported influential personal preferences	6-months from study entry	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	1-week after study entry	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	6-months from study entry	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.

Countries

United States

Outcome results

None listed