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

Stage III Prostate Cancer Clinical Trial

Official title:

Testing Decision Aids to Improve Prostate Cancer Decisions for Minority Men

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03103321
• Other study ID #: A191402CD
• Secondary ID: NCI-2017-00482
• Status: Completed
• Phase: Phase 3
• Start date: July 14, 2017
• Est. completion date: November 25, 2020

Study information

• Verified date: February 2024
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: November 25, 2020
• Est. primary completion date: December 5, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostatic Neoplasms
• PSA Level Five to Ten
• PSA Level Less Than Five
• PSA Level Ten to Fifty
• Stage I Prostate Cancer
• Stage II Prostate Cancer
• Stage IIA Prostate Cancer
• Stage IIB Prostate Cancer
• Stage III Prostate Cancer

Intervention

Other:
• Internet-Based Intervention
Receive "Knowing your Options" decision aid
• Internet-Based Intervention
Receive "Prostate Choice" decision aid
• Best Practice
Undergo usual care
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies
• Survey Administration
Ancillary studies
• Laboratory Biomarker Analysis
Correlative studies

Locations

Country	Name	City	State
United States	University of New Mexico Cancer Center	Albuquerque	New Mexico
United States	Augusta University Medical Center	Augusta	Georgia
United States	Ochsner Health Center-Summa	Baton Rouge	Louisiana
United States	Kaiser Permanente-Bellflower	Bellflower	California
United States	James J Peters VA Medical Center	Bronx	New York
United States	Montefiore Medical Center - Moses Campus	Bronx	New York
United States	Montefiore Medical Center-Einstein Campus	Bronx	New York
United States	Montefiore Medical Center-Weiler Hospital	Bronx	New York
United States	Medical University of South Carolina	Charleston	South Carolina
United States	John H Stroger Jr Hospital of Cook County	Chicago	Illinois
United States	Prisma Health Cancer Institute - Laurens	Clinton	South Carolina
United States	Prisma Health Cancer Institute - Easley	Easley	South Carolina
United States	Prisma Health Cancer Institute - Butternut	Greenville	South Carolina
United States	Prisma Health Cancer Institute - Eastside	Greenville	South Carolina
United States	Prisma Health Cancer Institute - Faris	Greenville	South Carolina
United States	Prisma Health Greenville Memorial Hospital	Greenville	South Carolina
United States	Prisma Health Cancer Institute - Greer	Greer	South Carolina
United States	Tripler Army Medical Center	Honolulu	Hawaii
United States	Northwell Health/Center for Advanced Medicine	Lake Success	New York
United States	Kaiser Permanente-Cadillac	Los Angeles	California
United States	Ochsner Medical Center Jefferson	New Orleans	Louisiana
United States	NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center	New York	New York
United States	Kaiser Permanente Oakland-Broadway	Oakland	California
United States	Virginia Commonwealth University/Massey Cancer Center	Richmond	Virginia
United States	William Beaumont Hospital-Royal Oak	Royal Oak	Michigan
United States	Prisma Health Cancer Institute - Seneca	Seneca	South Carolina
United States	Louisiana State University Health Sciences Center Shreveport	Shreveport	Louisiana
United States	Prisma Health Cancer Institute - Spartanburg	Spartanburg	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knowledge Assessed by Prostate Cancer Treatment Questionnaire	The primary outcome, knowledge, will be assessed by a standardized questionnaire (i.e., Prostate Cancer Treatment Questionnaire) administered once, immediately after the clinical consultation while the patient is still at the study site. The number correct from this 12-item measure will be reduced to a percentage of total number correct. With 100%(12 out of 12 item average) being the best possible outcome and 0%(0 out of 12 item average) the worst possible outcome	12 months
Secondary	Decisional Quality as Measured by Decisional Conflict Scale Decisional Regret	The Decisional Regret Scale is a short, 5-item scale measuring "distress or remorse after a (health care) decision." The instrument has been validated in other decision aid studies. Questions are answered on a 5-point agreement scale. A score of 0 means no decisional regret and 5 is the maximum level of regret. The median scores for each cohort were grouped into two categories, 0(no regret) and 1+(at least some regret).	12 months
Secondary	Clinical Time Required	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.	12 months
Secondary	Quality of Life Assessed by Questionnaire	The Expanded Prostate Cancer Index Composite(EPIC-26) measures health-related quality of life and returns summary scores for urinary, bowel, sexual, and hormonal domains with high test-retest reliability and internal consistency. Scores will be converted into continuous summary scores using standard algorithms. For the EPIC-26 questionnaire, scores were transformed into 0 to 100 scales, with a score of 0 representing the worst possible health-related quality of life and a score of 100 representing the most favorable health-related quality of life. The questionnaire will be administered once; 12 months after the patient's initial consultation.	12 months
Secondary	Utilization as Determined by Chart Review	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.	12 months