Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Decision Aids in Improving Knowledge in Patients With Newly Diagnosed 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03103321
Recruitment Status : Recruiting
First Posted : April 6, 2017
Last Update Posted : March 5, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Tracking Information
First Submitted Date  ICMJE March 31, 2017
First Posted Date  ICMJE April 6, 2017
Last Update Posted Date March 5, 2019
Actual Study Start Date  ICMJE July 14, 2017
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 31, 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, and a random, site-specific intercept to allow patients within the same site to be correlated. Baseline patient-level characteristics including race, ethnicity, severity of disease and site-level characteristics may be incorporated in this model if deemed appropriate. A similar approach will be utilized in the statistical analysis of secondary endpoints. Furthermore, descriptive statistics will be reported after incorporating cluster information, in particular, the empirical cluster size, and the observed intra-cluster correlation.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03103321 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 31, 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.
  • Clinical time required [ 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 in Improving Knowledge in Patients With Newly Diagnosed 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 newly diagnosed 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

PRIMARY OBJECTIVES:

I. To test the comparative effectiveness of decision aids (DA's) on patient knowledge.

SECONDARY OBJECTIVES:

I. To test the impact of in-visit DA's alone compared to usual care on quality of life outcomes and treatment utilization.

II. To test the impact of out-of-visit DA's alone compared to usual care on quality of life outcomes and treatment utilization.

III. To test the impact of combined in-visit and out-of-visit DA's compared to both usual care and individual DAs on quality of life outcomes and treatment utilization.

IV. To test the comparative effectiveness of DA's on minority men's knowledge. V. To compare clinic time required to administer the DA's across arms.

OUTLINE: Patients are randomized into 1 of 4 arms.

ARM A: Patients receive decision aids "Knowing your Options" before and "Prostate Choice" during their consultation visit.

ARM B: Patients receive "Knowing your Options" decision aid before their consultation visit.

ARM C: Patients receive "Prostate Choice" decision aid during their consultation visit.

ARM D: Patients undergo usual care.

After completion of study, patients are followed up at 12 months.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Stage II Prostate Cancer
  • Stage IIA Prostate Cancer
  • Stage IIB Prostate Cancer
  • Stage III Prostate Cancer
  • Stage I Prostate Cancer
  • PSA Level Five to Ten
  • PSA Level Less Than Five
  • PSA Level Ten to Fifty
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 Names:
    • standard of care
    • standard therapy
  • Other: Quality-of-Life Assessment
    Ancillary studies
  • 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", "Prostate Choice")
    Patients receive decision aids "Knowing your Options" before and "Prostate Choice" during their consultation visit.
    Interventions:
    • Other: Internet-Based Intervention
    • Other: Internet-Based Intervention
    • Other: Quality-of-Life Assessment
    • Other: Questionnaire Administration
    • Other: Survey Administration
    • Other: Laboratory Biomarker Analysis
  • Experimental: Arm B ("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 C ("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 D (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 * Pacyna JE, Kim S, Yost K, Sedlacek H, Petereit D, Kaur J, Rapkin B, Grubb R, Paskett E, Chang GJ, Sloan J, Basch E, Major B, Novotny P, Taylor J, Buckner J, Parsons JK, Morris M, Tilburt JC. The comparative effectiveness of decision aids in diverse populations with early stage prostate cancer: a study protocol for a cluster-randomized controlled trial in the NCI Community Oncology Research Program (NCORP), Alliance A191402CD. BMC Cancer. 2018 Aug 6;18(1):788. doi: 10.1186/s12885-018-4672-3.

*   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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 31, 2017)
172
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2020
Estimated Primary Completion Date January 2020   (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: Jon Tilburt, MD 855-776-0015 tilburt.jon@mayo.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03103321
Other Study ID Numbers  ICMJE A191402CD
NCI-2017-00482 ( Registry Identifier: NCI Clinical Trial Reporting Program )
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 Not Provided
Responsible Party Alliance for Clinical Trials in Oncology
Study Sponsor  ICMJE Alliance for Clinical Trials in Oncology
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: tilburt.jon@mayo.edu tilburt.jon@mayo.edu, MD Mayo Clinic
PRS Account Alliance for Clinical Trials in Oncology
Verification Date March 2019

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