We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Decision Aids to Improve Knowledge in Patients With Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03182998
Recruitment Status : Active, not recruiting
First Posted : June 9, 2017
Last Update Posted : February 22, 2023
Sponsor:
Collaborator:
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
Jon C. Tilburt, Mayo Clinic

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This randomized phase III trial studies how well decision aids work in improving knowledge in patients with prostate cancer. Decision aids may improve patients' knowledge of their condition and options for treatment, and may also help when talking with their doctor.

Condition or disease Intervention/treatment Phase
Prostate Cancer Other: Internet-Based Intervention Other: Best Practice Other: Quality-of-Life Assessment Other: Questionnaire Administration Other: Survey Administration Other: Laboratory Biomarker Analysis Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Testing Decision Aids to Improve Prostate Cancer Decisions for Minority Men
Actual Study Start Date : July 14, 2017
Actual Primary Completion Date : September 17, 2019
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Arm A (Knowing Your Options)
Arm A ("Knowing your Options") Patients receive "Knowing your Options" decision aid before their consultation visit.
 Other: Internet-Based Intervention
Receive "Knowing your Options" decision aid

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment, Quality-of-Life Assessment

Other: Questionnaire Administration
Ancillary studies

Other: Survey Administration
Ancillary studies

Other: Laboratory Biomarker Analysis
Correlative studies
Experimental: Arm B (Prostate Choice)
Patients receive "Prostate Choice" decision aid during their consultation visit.
 Other: Internet-Based Intervention
Receive "Prostate Choice" decision aid

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment, Quality-of-Life Assessment

Other: Questionnaire Administration
Ancillary studies

Other: Survey Administration
Ancillary studies

Other: Laboratory Biomarker Analysis
Correlative studies
Active Comparator: Arm C (Usual Care)
Patients undergo usual care.
 Other: Best Practice
Undergo usual care
Other Name: best practice, Best Practice, standard of care, standard therapy

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment, Quality-of-Life Assessment

Other: Questionnaire Administration
Ancillary studies

Other: Survey Administration
Ancillary studies

Other: Laboratory Biomarker Analysis
Correlative studies


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Knowledge assessed by Prostate Cancer Treatment questionnaire [ Time Frame: Up to 12 months ]
    A mixed effects regression model (also known as random effects model or multi-level model) will be utilized to examine the effects of the during-consultation Prostate Choice and the pre-consultation Knowing Your Options decision aids. Specifically, this model will contain a fixed intercept, a fixed effect for having received Prostate Choice, a fixed effect for having received Knowing Your Options. Baseline patient-level characteristics including race, ethnicity, severity of disease and site-level characteristics may be incorporated in this model if deemed appropriate.


Secondary Outcome Measures :
  1. Decisional quality as measured by Decisional Conflict Scale Decisional Regret [ Time Frame: Up to 12 months ]
    Will be compared across DA types using linear mixed models. In particular, this model will include fixed effects for Prostate Choice and Knowing Your Options and a random, site-specific intercept to allow for subjects within the same site to be correlated. Will explore whether the overall effects of interventions on patient knowledge, quality of life, and treatment utilization differ by racial/ethnic subgroups.

  2. Quality of life assessed by questionnaire [ Time Frame: Up to 12 months ]
    Will be converted into continuous summary scores using standard algorithms. Will be compared across DA types using linear mixed models. In particular, this model will include fixed effects for Prostate Choice and Knowing Your Options and a random, site-specific intercept to allow for subjects within the same site to be correlated. Will explore whether the overall effects of interventions on patient knowledge, quality of life, and treatment utilization differ by racial/ethnic subgroups.

  3. Utilization as determined by chart review [ Time Frame: At 12 months ]
    Will be categorized by the type of treatment the patient received. Will be compared across DA types using linear mixed models. In particular, this model will include fixed effects for Prostate Choice and Knowing Your Options and a random, site-specific intercept to allow for subjects within the same site to be correlated. Will explore whether the overall effects of interventions on patient knowledge, quality of life, and treatment utilization differ by racial/ethnic subgroups.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have prostate biopsy within 4 months prior to registration showing newly diagnosed prostate cancer, stage T1-3N0M0; in addition, patients must have: Gleason score 6-10
  • Prostate-specific antigen (PSA) < 50 ng/mL
  • Patients who have had a history of non-cutaneous malignancy in the previous 5 years are not eligible; exception: patients with history of non-melanoma skin cancer are eligible
  • Scheduled prostate cancer consultation to be the first consultation after diagnosis (i.e. not a second-opinion or a consultation following previous discussions of treatment options)
  • Patients may not be concurrently enrolled to another clinical trial for the treatment of cancer; co-enrollment to biospecimen studies is allowed
  • Patients with impaired decision-making capacity (such as with a diagnosis of dementia or memory loss) are not eligible for this study
  • Patients must be able to read and comprehend English; non-English-speaking patients may participate so long as an interpreter (e.g., family member, clinic staff, etc.) is present for consent, for the decision aid administration, and gathering of baseline and follow-up measures
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03182998


Locations
Layout table for location information
United States, Alaska
Alaska Native Tribal Health Consortium
Anchorage, Alaska, United States, 99508
United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
Metrohealth Medical Center Urology Institute
Cleveland, Ohio, United States, 44109
United States, South Dakota
Regional Health
Rapid City, South Dakota, United States, 57701
Sponsors and Collaborators
Mayo Clinic
National Institute on Minority Health and Health Disparities (NIMHD)
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Jon C. Tilburt, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03182998    
Other Study ID Numbers: 16-010459
R01MD008934-05 ( U.S. NIH Grant/Contract )
First Posted: June 9, 2017    Key Record Dates
Last Update Posted: February 22, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases