Devel. and Eval. of an Active Surveillance Decision Aid for Men With Low or Intermediate Grade Prostate Cancer
NCT ID: NCT02342626
Last Updated: 2018-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
140 participants
INTERVENTIONAL
2015-01-31
2017-12-31
Brief Summary
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Detailed Description
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Specifically, we propose to conduct a clinical trial to compare the effects of a prostate decision dashboard versus usual care on:
1. patient knowledge regarding the treatment options available for low or intermediate risk prostate cancer,
2. measures of the decision making process including decisional conflict and the extent to which decisions were made via a shared decision making process,
3. the treatments selected, and
4. 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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Control
No use of the decision aid dashboard before, during or after the treatment decision time period.
No interventions assigned to this group
Dashboard
Use of the decision aid dashboard before, during and after the treatment decision time period.
Dashboard
With the health care provider, subjects will use the decision dashboard to augment the discussion of treatment options.
Interventions
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Dashboard
With the health care provider, subjects will use the decision dashboard to augment the discussion of treatment options.
Eligibility Criteria
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Inclusion Criteria
* 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
* Unwilling to participate.
* Deemed clinically unsuitable for active surveillance as a prostate cancer management option
40 Years
85 Years
MALE
No
Sponsors
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University of Rochester
OTHER
Responsible Party
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James Dolan
Associate Professor
Principal Investigators
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James G Dolan
Role: PRINCIPAL_INVESTIGATOR
University of Rochester
Locations
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University of Rochester Medical Center
Rochester, New York, United States
Countries
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Other Identifiers
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UCCS14115
Identifier Type: -
Identifier Source: org_study_id
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