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NCT Number: NCT03387527

Using Decision Analysis to Enhance Decision-Making Regarding Prostate Cancer Screening

The purpose of this study is to evaluate a new counseling tool for patients deciding whether or not to undergo prostate cancer screening. This screening decision aid is a computer program that provides individual patients estimates of their risks of prostate cancer diagnosis, prostate cancer related death, or death from any cause. The researchers are evaluating whether or not patients find this screening decision aid helpful. As part of this study, participants will be asked for their response on questionnaires.

If patients find the screening decision aid helpful, the researchers will make it available at other clinic locations.

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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

55 year–69 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

About this study

To conduct a feasibility study on implementing the computer-based screening decision aid for prostate cancer screening in a primary care setting during a 60-minute interview. To aid in informed decision making, the screening decision aid will include a graphical representation of predicted probabilities of prostate cancer diagnosis, prostate cancer-specific mortality, death from competing causes based on a man's unique demographic information. The study team will provide standardized counseling followed by individualized counseling with the screening decision aid. It will assess the quality of the decision making process (patient feels knowledgeable, informed of the risks/benefits, feels clear about their values, is involved in the decision), and quality of the decision.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Life expectancy > 10 years
  • Ability to read English

Exclusion criteria

  • Personal history of prostate cancer
  • Personal history of prostate biopsy or prostate surgery
  • Prior prostate specific antigen screening in the past year leading up to their scheduled clinic visit
  • Cognitive impairment

Treatment and study plan

Prostate cancer decision aid

Behavioral

Patients will undergo standardized counseling and individualized counseling with the screening decision aid. The screening decision aid is a computer program that provides individual patients estimates of their risks of prostate cancer diagnosis, prostate cancer related death, or death from any cause

Other names: screening decision aid

Primary outcomes

  1. Number of initial interviews completed in 60 minutes

    Time frame: 60 minutes from beginning of interview

    To be considered feasible in a busy clinical setting, researchers anticipate 80% of the initial interviews to be completed within the allotted 60-minute interview time.

Secondary outcomes

  1. Health Literacy

    Time frame: 1 month after clinical visit

    Five item scale measuring attitudes towards screening

  2. Patient decisional control preferences

    Time frame: 1 month after clinical visit

    4 item scale where lower scores indicate more positive outcomes from screening

  3. Decisional conflict Scale

    Time frame: 1 month after clinical visit

    16 item scale ranging in a score from 0-4 where higher scores indicate more disagreement

  4. Multidimensional measure of informed choice

    Time frame: 1 month after clinical visit

    10 item true/false scale

  5. Decisional regret scale

    Time frame: 1 month after clinical visit

    5 item questionnaire using 5 point Likert scales where higher scores indicate more disagreement

Sponsors and collaborators

Lead sponsor

Case Comprehensive Cancer Center

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 2, 2018
Registry last updated
Oct 24, 2019

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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