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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03387527
Enrollment
50
Registered
2018-01-02
Start date
2018-02-01
Completion date
2018-11-03
Last updated
2019-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

Decision Aid

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALProstate cancer decision aid

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

Sponsors

Case Comprehensive Cancer Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
55 Years to 69 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Number of initial interviews completed in 60 minutes60 minutes from beginning of interviewTo 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

MeasureTime frameDescription
Health Literacy1 month after clinical visitFive item scale measuring attitudes towards screening
Patient decisional control preferences1 month after clinical visit4 item scale where lower scores indicate more positive outcomes from screening
Decisional conflict Scale1 month after clinical visit16 item scale ranging in a score from 0-4 where higher scores indicate more disagreement
Multidimensional measure of informed choice1 month after clinical visit10 item true/false scale
Decisional regret scale1 month after clinical visit5 item questionnaire using 5 point Likert scales where higher scores indicate more disagreement

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026