Decision Aids to Improve Knowledge in Patients With Prostate Cancer

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: NCT03182998
• Other study ID #: 16-010459
• Secondary ID: R01MD008934-05
• Status: Completed
• Phase: N/A
• Start date: July 14, 2017
• Est. completion date: February 4, 2022

Study information

• Verified date: July 2023
• Source: Mayo Clinic
• 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 prostate cancer. Decision aids may improve patients' knowledge of their condition and options for treatment, and may also help when talking with their doctor.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: February 4, 2022
• Est. primary completion date: February 4, 2022
• 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

• Prostate Cancer
• Prostatic Neoplasms

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	Alaska Native Tribal Health Consortium	Anchorage	Alaska
United States	Metrohealth Medical Center Urology Institute	Cleveland	Ohio
United States	University Hospitals Case Medical Center	Cleveland	Ohio
United States	Regional Health	Rapid City	South Dakota
United States	Mayo Clinic	Scottsdale	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Institute on Minority Health and Health Disparities (NIMHD)

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 proportion of total number correct. With 1.0 (12 out of 12 item average) being the best possible outcome and 0.0 (0 out of 12 item average) the worst possible outcome	12 months
Secondary	Decisional Quality as Measured by Decisional Regret Scale	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 continuous scores were then grouped into two categories, 0 (no regret) and 1+ (at least some regret).	12 months
Secondary	Quality of Life Assessed by Questionnaire	The Expanded Prostate Cancer Index Composit (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 represented 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 elected to receive. Will be compared across intervention arms.	12 months