Decision Aids to Improve Knowledge in Patients With Prostate Cancer

• ClinicalTrials.gov Identifier: NCT03182998
• Recruitment Status: Active, not recruiting
• First Posted: June 9, 2017
• Last Update Posted: February 22, 2023
• Sponsor: Mayo Clinic
• 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: June 8, 2017
• First Posted Date: June 9, 2017
• Last Update Posted Date: February 22, 2023
• Actual Study Start Date: July 14, 2017
• Actual Primary Completion Date: September 17, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Decision Aids to Improve Knowledge in Patients With Prostate Cancer
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Other
• Condition: Prostate Cancer

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: October 2, 2019): 103
• Original Estimated Enrollment (submitted: June 8, 2017): 100
• Estimated Study Completion Date: December 31, 2025
• Actual Primary Completion Date: September 17, 2019 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03182998
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Current Responsible Party: Jon C. Tilburt, Mayo Clinic
• Original Responsible Party: Same as current
• Current Study Sponsor: Mayo Clinic
• Original Study Sponsor: Same as current
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
• Investigators: Not Provided
• PRS Account: Mayo Clinic
• Verification Date: February 2023