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Trial record 1 of 1 for:    a191402cd
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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03103321
Recruitment Status : Active, not recruiting
First Posted : April 6, 2017
Last Update Posted : February 24, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

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.

Condition or disease Intervention/treatment Phase
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 Other: Internet-Based Intervention Other: Best Practice Other: Quality-of-Life Assessment Other: Questionnaire Administration Other: Survey Administration Other: Laboratory Biomarker Analysis Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 158 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Testing Decision Aids to Improve Prostate Cancer Decisions for Minority Men
Actual Study Start Date : July 14, 2017
Actual Primary Completion Date : December 5, 2019
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Arm A ("Knowing your Options", "Prostate Choice")
Patients receive decision aids "Knowing your Options" before and "Prostate Choice" during their consultation visit.
Other: Internet-Based Intervention
Receive "Knowing your Options" decision aid

Other: Internet-Based Intervention
Receive "Prostate Choice" decision aid

Other: Quality-of-Life Assessment
Ancillary studies

Other: Questionnaire Administration
Ancillary studies

Other: Survey Administration
Ancillary studies

Other: Laboratory Biomarker Analysis
Correlative studies

Experimental: Arm B ("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: Questionnaire Administration
Ancillary studies

Other: Survey Administration
Ancillary studies

Other: Laboratory Biomarker Analysis
Correlative studies

Experimental: Arm C ("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: Questionnaire Administration
Ancillary studies

Other: Survey Administration
Ancillary studies

Other: Laboratory Biomarker Analysis
Correlative studies

Active Comparator: Arm D (usual care)
Patients undergo usual care.
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




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, 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.


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. 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.

  3. 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.

  4. 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.



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.


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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): NCT03103321


Locations
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Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Investigators
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Study Chair: tilburt.jon@mayo.edu tilburt.jon@mayo.edu, MD Mayo Clinic
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT03103321    
Other Study ID Numbers: A191402CD
NCI-2017-00482 ( Registry Identifier: NCI Clinical Trial Reporting Program )
First Posted: April 6, 2017    Key Record Dates
Last Update Posted: February 24, 2020
Last Verified: February 2020

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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