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Decision Aids to Improve Knowledge in Patients With Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Internet-Based Intervention
Internet-Based Intervention
Best Practice
Quality-of-Life Assessment
Questionnaire Administration
Survey Administration
Laboratory Biomarker Analysis
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Alaska Native Tribal Health Consortium
  • Mayo Clinic
  • University Hospitals Case Medical Center
  • Metrohealth Medical Center Urology Institute
  • Regional Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Arm A (Knowing Your Options)

Arm B (Prostate Choice)

Arm C (Usual Care)

Arm Description

Arm A ("Knowing your Options") Patients receive "Knowing your Options" decision aid before their consultation visit.

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

Patients undergo usual care.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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).
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.
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.

Full Information

First Posted
June 8, 2017
Last Updated
July 13, 2023
Sponsor
Mayo Clinic
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
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1. Study Identification

Unique Protocol Identification Number
NCT03182998
Brief Title
Decision Aids to Improve Knowledge in Patients With Prostate Cancer
Official Title
Testing Decision Aids to Improve Prostate Cancer Decisions for Minority Men
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
July 14, 2017 (Actual)
Primary Completion Date
February 4, 2022 (Actual)
Study Completion Date
February 4, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
103 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A (Knowing Your Options)
Arm Type
Experimental
Arm Description
Arm A ("Knowing your Options") Patients receive "Knowing your Options" decision aid before their consultation visit.
Arm Title
Arm B (Prostate Choice)
Arm Type
Experimental
Arm Description
Patients receive "Prostate Choice" decision aid during their consultation visit.
Arm Title
Arm C (Usual Care)
Arm Type
Active Comparator
Arm Description
Patients undergo usual care.
Intervention Type
Other
Intervention Name(s)
Internet-Based Intervention
Intervention Description
Receive "Knowing your Options" decision aid
Intervention Type
Other
Intervention Name(s)
Internet-Based Intervention
Intervention Description
Receive "Prostate Choice" decision aid
Intervention Type
Other
Intervention Name(s)
Best Practice
Other Intervention Name(s)
best practice, Best Practice, standard of care, standard therapy
Intervention Description
Undergo usual care
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment, Quality-of-Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Survey Administration
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Knowledge Assessed by Prostate Cancer Treatment Questionnaire
Description
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
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Decisional Quality as Measured by Decisional Regret Scale
Description
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).
Time Frame
12 months
Title
Quality of Life Assessed by Questionnaire
Description
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.
Time Frame
12 months
Title
Utilization as Determined by Chart Review
Description
Will be categorized by the type of treatment the patient elected to receive. Will be compared across intervention arms.
Time Frame
12 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jon C. Tilburt, M.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alaska Native Tribal Health Consortium
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Mayo Clinic
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
University Hospitals Case Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Metrohealth Medical Center Urology Institute
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
Regional Health
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Decision Aids to Improve Knowledge in Patients With Prostate Cancer

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