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OpenTrials
Completed

NCT Number: NCT02342626

Devel. and Eval. of an Active Surveillance Decision Aid for Men With Low or Intermediate Grade Prostate Cancer

The overall goal of this project is to test an interactive, multi-media decision aid in the form of an electronic clinical decision dashboard designed to improve the quality of clinical decision making for initial treatment of patients with newly diagnosed, low or intermediate risk prostate cancer.

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Key information

Conditions

Adenocarcinoma of Prostate Adenocarcinoma Carcinoma Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial

Age range

40 year–85 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Rochester Medical Center

Rochester, New York, 14642, United States

About this study

The overall goal of this project is to test an interactive, multi-media decision aid in the form of an electronic clinical decision dashboard designed to improve the quality of clinical decision making for initial treatment of patients with newly diagnosed, low or intermediate risk prostate cancer.

Specifically, we propose to conduct a clinical trial to compare the effects of a prostate decision dashboard versus usual care on:

  • patient knowledge regarding the treatment options available for low or intermediate risk prostate cancer,
  • measures of the decision making process including decisional conflict and the extent to which decisions were made via a shared decision making process,
  • the treatments selected, and
  • 3-6 and 9-12 month outcome assessments of clinical status, decision regret, cancer-related quality of life including worry, functional status, and treatment side effects.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age: 40 to 85 years
  • Sex: male
  • Race/ethnicity: no restrictions
  • Diagnosis: Patients will be eligible for the study if they have not yet decided on a management plan and present with either:
  • localized, low grade prostate cancer, defined as Gleason score ≤ 6, T1-T2a stage cancers, and PSA values < 10 ng/ml, OR
  • Intermediate risk prostate cancer, defined as Gleason score = 7, T2b-T2c stage cancers (these tumors involve more of the prostate but do not extend beyond the prostatic capsule), or PSA 10-20 ng/ml
  • Willing to participate and able to give informed consent
  • Able to adequately see the study intervention which is an interactive decision dashboard & complete study-related questionnaires
  • Able to understand English language adequately to use the decision dashboard and complete study-related questionnaires

Exclusion criteria

  • Unable to complete study-related tasks due to cognitive deficits or English non-fluency
  • Unwilling to participate.
  • Deemed clinically unsuitable for active surveillance as a prostate cancer management option

Treatment and study plan

Dashboard

Behavioral

With the health care provider, subjects will use the decision dashboard to augment the discussion of treatment options.

Primary outcomes

  1. Increase in KUJ score through education

    Time frame: 2 years

    The use of the dashboard will increase patient knowledge and understanding of treatment options as measured using KUJ questionnaire.

Secondary outcomes

  1. Measure of overall quality and satisfaction with initial treatment decision.

    Time frame: 2 years

    The use of the dashboard will improve the overall quality and satisfaction with initial treatment decisions as measured by a) decisional conflict, b) patient quality of life, and c) post-decision regret, using the PORPUS questionnaire and Decisional Regret questionnaire.

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Registry information

Official study title

CDC SIP: Rochester Prevention Research Center: Development and Evaluation of an Active Surveillance Decision Aid for Men With Low or Intermediate Grade Prostate Cancer

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jan 21, 2015
Registry last updated
Jan 9, 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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