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Trial record 96 of 1932 for:    ( Map: South Dakota, United States )

Decision Aids to Improve Knowledge in Patients With Prostate Cancer

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ClinicalTrials.gov Identifier: NCT03182998
Recruitment Status : Recruiting
First Posted : June 9, 2017
Last Update Posted : April 9, 2019
Sponsor:
Collaborator:
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
Jon C. Tilburt, Mayo Clinic

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Testing Decision Aids to Improve Prostate Cancer Decisions for Minority Men
Actual Study Start Date : July 14, 2017
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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




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.



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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

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
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United States, Alaska
Alaska Native Tribal Health Consortium Recruiting
Anchorage, Alaska, United States, 99508
Contact: Barbara Stillwater, PhD    907-729-2446    bjstillwater@anthc.org   
Principal Investigator: Mariam Miller, MD         
United States, Ohio
University Hospitals Case Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Hillary Sedlacek    734-277-4317    Hillary.Sedlacek@UHhospitals.org   
Principal Investigator: Simon Kim, MD, MPH         
Metrohealth Medical Center Urology Institute Recruiting
Cleveland, Ohio, United States, 44109
Contact: Hillary Sedlacek    734-277-4317    Hillary.Sedlacek@UHhospitals.orgHillary.Sedlacek@UHhospitals.org   
Principal Investigator: Carvell Nguyen, MD         
United States, South Dakota
Regional Health Recruiting
Rapid City, South Dakota, United States, 57701
Contact: Kristin Cina    605-755-2305    kcina@regionalhealth.org   
Principal Investigator: Dan Petereit, MD         
Sponsors and Collaborators
Mayo Clinic
National Institute on Minority Health and Health Disparities (NIMHD)

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Responsible Party: Jon C. Tilburt, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03182998     History of Changes
Other Study ID Numbers: 16-010459
R01MD008934-05 ( U.S. NIH Grant/Contract )
First Posted: June 9, 2017    Key Record Dates
Last Update Posted: April 9, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases