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Decision Aids in Improving Knowledge in Patients With Newly Diagnosed Prostate Cancer

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ClinicalTrials.gov Identifier: NCT03103321
Recruitment Status : Recruiting
First Posted : April 6, 2017
Last Update Posted : June 12, 2018
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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 172 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
Estimated Primary Completion Date : January 2020
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

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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


Contacts
Contact: Jon Tilburt, MD 855-776-0015 tilburt.jon@mayo.edu

Locations
United States, California
Kaiser Permanente-Bellflower Recruiting
Bellflower, California, United States, 90706
Contact: Han A. Koh    800-398-3996    clinical.trials@kp.org   
Principal Investigator: Han A. Koh         
Kaiser Permanente-Cadillac Suspended
Los Angeles, California, United States, 90034
Kaiser Permanente Oakland-Broadway Recruiting
Oakland, California, United States, 94611
Contact: Samantha A. Seaward    510-891-3400      
Principal Investigator: Samantha A. Seaward         
United States, Georgia
Augusta University Medical Center Recruiting
Augusta, Georgia, United States, 30912
Contact: Sharad A. Ghamande    706-721-1663    cancer@augusta.edu   
Principal Investigator: Sharad A. Ghamande         
United States, Hawaii
Tripler Army Medical Center Recruiting
Honolulu, Hawaii, United States, 96859
Contact: John E. Musser    808-433-6336      
Principal Investigator: John E. Musser         
United States, Illinois
John H Stroger Jr Hospital of Cook County Recruiting
Chicago, Illinois, United States, 60612
Contact: Thomas E. Lad    312-864-6000      
Principal Investigator: Thomas E. Lad         
United States, Louisiana
Ochsner Health Center-Summa Suspended
Baton Rouge, Louisiana, United States, 70809
Ochsner Medical Center Jefferson Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Daniel J. Canter    504-842-3708      
Principal Investigator: Daniel J. Canter         
Louisiana State University Health Sciences Center Shreveport Recruiting
Shreveport, Louisiana, United States, 71103
Contact: Kara N. Babaian    318-813-1412      
Principal Investigator: Kara N. Babaian         
United States, Michigan
William Beaumont Hospital-Royal Oak Recruiting
Royal Oak, Michigan, United States, 48073
Contact: Sugandh D. Shetty    248-551-7695      
Principal Investigator: Sugandh D. Shetty         
United States, New Mexico
University of New Mexico Cancer Center Recruiting
Albuquerque, New Mexico, United States, 87102
Contact: Michael S. Davis    505-925-0366    LByatt@nmcca.org   
Principal Investigator: Michael S. Davis         
United States, New York
Montefiore Medical Center-Einstein Campus Recruiting
Bronx, New York, United States, 10461
Contact: Evan Kovac    718-904-2730    aecc@aecom.yu.edu   
Principal Investigator: Evan Kovac         
Montefiore Medical Center-Weiler Hospital Suspended
Bronx, New York, United States, 10461
Montefiore Medical Center - Moses Campus Suspended
Bronx, New York, United States, 10467
Bronx Veterans Administration Medical Center Recruiting
Bronx, New York, United States, 10468
Contact: Christopher B. Anderson    718-584-9000    kl2965@cumc.columbia.edu   
Principal Investigator: Christopher B. Anderson         
Northwell Health/Center for Advanced Medicine Recruiting
Lake Success, New York, United States, 11042
Contact: Michael A. Diefenbach    516-734-8896      
Principal Investigator: Michael A. Diefenbach         
Columbia University/Herbert Irving Cancer Center Recruiting
New York, New York, United States, 10032
Contact: Guarionex J. DeCastro    212-305-8615      
Principal Investigator: Guarionex J. DeCastro         
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Chanita Hughes-Halbert    843-792-9321      
Principal Investigator: Chanita Hughes-Halbert         
Greenville Health System Cancer Institute-Laurens Suspended
Clinton, South Carolina, United States, 29325
Greenville Health System Cancer Institute-Easley Suspended
Easley, South Carolina, United States, 29640
Greenville Health System Cancer Institute-Butternut Suspended
Greenville, South Carolina, United States, 29605
Greenville Health System Cancer Institute-Faris Suspended
Greenville, South Carolina, United States, 29605
Greenville Memorial Hospital Recruiting
Greenville, South Carolina, United States, 29605
Contact: Jeffrey K. Giguere    864-679-3966      
Principal Investigator: Jeffrey K. Giguere         
Greenville Health System Cancer Institute-Eastside Suspended
Greenville, South Carolina, United States, 29615
Greenville Health System Cancer Institute-Greer Suspended
Greer, South Carolina, United States, 29650
Greenville Health System Cancer Institute-Seneca Suspended
Seneca, South Carolina, United States, 29672
Greenville Health System Cancer Institute-Spartanburg Suspended
Spartanburg, South Carolina, United States, 29307
United States, Virginia
Virginia Commonwealth University/Massey Cancer Center Recruiting
Richmond, Virginia, United States, 23298
Contact: Asit K. Paul    773-702-9171    protocols@AllianceNCTN.org   
Principal Investigator: Asit K. Paul         
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Investigators
Study Chair: tilburt.jon@mayo.edu tilburt.jon@mayo.edu, MD Mayo Clinic

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT03103321     History of Changes
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: June 12, 2018
Last Verified: June 2018

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

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