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Decision Aids to Improve Knowledge in Patients With Prostate Cancer

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ClinicalTrials.gov Identifier: NCT03182998
Recruitment Status : Active, not recruiting
First Posted : June 9, 2017
Last Update Posted : December 3, 2020
Sponsor:
Collaborator:
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
Jon C. Tilburt, Mayo Clinic

Tracking Information
First Submitted Date  ICMJE June 8, 2017
First Posted Date  ICMJE June 9, 2017
Last Update Posted Date December 3, 2020
Actual Study Start Date  ICMJE July 14, 2017
Actual Primary Completion Date September 17, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 8, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 8, 2017)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Decision Aids to Improve Knowledge in Patients With Prostate Cancer
Official Title  ICMJE Testing Decision Aids to Improve Prostate Cancer Decisions for Minority Men
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • Other: Internet-Based Intervention
    Receive "Knowing your Options" decision aid
  • Other: Internet-Based Intervention
    Receive "Prostate Choice" decision aid
  • 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
Study Arms  ICMJE
  • Experimental: Arm A (Knowing Your Options)
    Arm A ("Knowing your Options") Patients receive "Knowing your Options" decision aid before their consultation visit.
    Interventions:
    • Other: Internet-Based Intervention
    • Other: Quality-of-Life Assessment
    • Other: Questionnaire Administration
    • Other: Survey Administration
    • Other: Laboratory Biomarker Analysis
  • Experimental: Arm B (Prostate Choice)
    Patients receive "Prostate Choice" decision aid during their consultation visit.
    Interventions:
    • Other: Internet-Based Intervention
    • Other: Quality-of-Life Assessment
    • Other: Questionnaire Administration
    • Other: Survey Administration
    • Other: Laboratory Biomarker Analysis
  • Active Comparator: Arm C (Usual Care)
    Patients undergo usual care.
    Interventions:
    • Other: Best Practice
    • Other: Quality-of-Life Assessment
    • Other: Questionnaire Administration
    • Other: Survey Administration
    • Other: Laboratory Biomarker Analysis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: October 2, 2019)
103
Original Estimated Enrollment  ICMJE
 (submitted: June 8, 2017)
100
Estimated Study Completion Date  ICMJE December 31, 2025
Actual Primary Completion Date September 17, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03182998
Other Study ID Numbers  ICMJE 16-010459
R01MD008934-05 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jon C. Tilburt, Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE National Institute on Minority Health and Health Disparities (NIMHD)
Investigators  ICMJE Not Provided
PRS Account Mayo Clinic
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP