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Completed

NCT Number: NCT01844999

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

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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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Kaiser Permanente - Souther California, Downey, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Personal Patient Profile - Prostate (P3P)

Behavioral

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

Standard prostate cancer information websites

Behavioral

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

Primary outcomes

  1. Decisional conflict

    Time frame: Change from baseline to 6-months

    O'Connor, 1995, Decisional conflict scale

  2. Preparation for decision making

    Time frame: 1-month after study entry

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

  3. Satisfaction with decision

    Time frame: 6-months after study entry

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

Secondary outcomes

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

    Time frame: 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).

  2. Net cost and benefit of the intervention

    Time frame: 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.

  3. Time to treatment decision

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
May 3, 2013
Registry last updated
Jan 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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