Trial Outcomes & Findings for Decision Aids in Improving Knowledge in Patients With Newly Diagnosed Prostate Cancer (NCT NCT03103321)
NCT ID: NCT03103321
Last Updated: 2025-01-27
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
158 participants
Primary outcome timeframe
12 months
Results posted on
2025-01-27
Participant Flow
Participant milestones
| Measure |
Pre- and During-consultation Decision Aids
Patients receive decision aids "Knowing your Options" before and "Prostate Choice" during their consultation visit.
Internet-Based Intervention: Receive "Knowing your Options" decision aid
Internet-Based Intervention: Receive "Prostate Choice" decision aid
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Survey Administration: Ancillary studies
Laboratory Biomarker Analysis: Correlative studies
|
Pre-consultation Decision Aids Only
Patients receive "Knowing your Options" decision aid before their consultation visit.
Internet-Based Intervention: Receive "Knowing your Options" decision aid
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Survey Administration: Ancillary studies
Laboratory Biomarker Analysis: Correlative studies
|
During-consultation Decision Aids Only
Patients receive "Prostate Choice" decision aid during their consultation visit.
Internet-Based Intervention: Receive "Prostate Choice" decision aid
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Survey Administration: Ancillary studies
Laboratory Biomarker Analysis: Correlative studies
|
Usual Care
Patients undergo usual care.
Best Practice: Undergo usual care
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Survey Administration: Ancillary studies
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
25
|
39
|
44
|
50
|
|
Overall Study
COMPLETED
|
24
|
38
|
43
|
50
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
Pre- and During-consultation Decision Aids
Patients receive decision aids "Knowing your Options" before and "Prostate Choice" during their consultation visit.
Internet-Based Intervention: Receive "Knowing your Options" decision aid
Internet-Based Intervention: Receive "Prostate Choice" decision aid
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Survey Administration: Ancillary studies
Laboratory Biomarker Analysis: Correlative studies
|
Pre-consultation Decision Aids Only
Patients receive "Knowing your Options" decision aid before their consultation visit.
Internet-Based Intervention: Receive "Knowing your Options" decision aid
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Survey Administration: Ancillary studies
Laboratory Biomarker Analysis: Correlative studies
|
During-consultation Decision Aids Only
Patients receive "Prostate Choice" decision aid during their consultation visit.
Internet-Based Intervention: Receive "Prostate Choice" decision aid
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Survey Administration: Ancillary studies
Laboratory Biomarker Analysis: Correlative studies
|
Usual Care
Patients undergo usual care.
Best Practice: Undergo usual care
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Survey Administration: Ancillary studies
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
1
|
1
|
0
|
Baseline Characteristics
Decision Aids in Improving Knowledge in Patients With Newly Diagnosed Prostate Cancer
Baseline characteristics by cohort
| Measure |
Pre- and During-consultation Decision Aids
n=25 Participants
Patients receive decision aids "Knowing your Options" before and "Prostate Choice" during their consultation visit.
Internet-Based Intervention: Receive "Knowing your Options" decision aid
Internet-Based Intervention: Receive "Prostate Choice" decision aid
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Survey Administration: Ancillary studies
Laboratory Biomarker Analysis: Correlative studies
|
Pre-consultation Decision Aids Only
n=39 Participants
Patients receive "Knowing your Options" decision aid before their consultation visit.
Internet-Based Intervention: Receive "Knowing your Options" decision aid
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Survey Administration: Ancillary studies
Laboratory Biomarker Analysis: Correlative studies
|
During-consultation Decision Aids Only
n=44 Participants
Patients receive "Prostate Choice" decision aid during their consultation visit.
Internet-Based Intervention: Receive "Prostate Choice" decision aid
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Survey Administration: Ancillary studies
Laboratory Biomarker Analysis: Correlative studies
|
Usual Care
n=50 Participants
Patients undergo usual care.
Best Practice: Undergo usual care
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Survey Administration: Ancillary studies
Laboratory Biomarker Analysis: Correlative studies
|
Total
n=158 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
62.5 years
STANDARD_DEVIATION 7.33 • n=5 Participants
|
63.1 years
STANDARD_DEVIATION 8.09 • n=7 Participants
|
64.6 years
STANDARD_DEVIATION 7.46 • n=5 Participants
|
63.4 years
STANDARD_DEVIATION 7.87 • n=4 Participants
|
63.5 years
STANDARD_DEVIATION 7.69 • n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
158 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
147 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 12 monthsThe 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
Outcome measures
| Measure |
Pre- and During-consultation Decision Aids
n=24 Participants
Patients receive decision aids "Knowing your Options" before and "Prostate Choice" during their consultation visit.
Internet-Based Intervention: Receive "Knowing your Options" decision aid
Internet-Based Intervention: Receive "Prostate Choice" decision aid
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Survey Administration: Ancillary studies
Laboratory Biomarker Analysis: Correlative studies
|
Pre-consultation Decision Aids Only
n=38 Participants
Patients receive "Knowing your Options" decision aid before their consultation visit.
Internet-Based Intervention: Receive "Knowing your Options" decision aid
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Survey Administration: Ancillary studies
Laboratory Biomarker Analysis: Correlative studies
|
During-consultation Decision Aids Only
n=43 Participants
Patients receive "Prostate Choice" decision aid during their consultation visit.
Internet-Based Intervention: Receive "Prostate Choice" decision aid
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Survey Administration: Ancillary studies
Laboratory Biomarker Analysis: Correlative studies
|
Usual Care
n=50 Participants
Patients undergo usual care.
Best Practice: Undergo usual care
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Survey Administration: Ancillary studies
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|---|---|---|
|
Knowledge Assessed by Prostate Cancer Treatment Questionnaire
|
0.69 percentage of items correct
Standard Deviation 0.165
|
0.65 percentage of items correct
Standard Deviation 0.164
|
0.58 percentage of items correct
Standard Deviation 0.167
|
0.56 percentage of items correct
Standard Deviation 0.232
|
SECONDARY outcome
Timeframe: 12 monthsThe 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).
Outcome measures
| Measure |
Pre- and During-consultation Decision Aids
n=24 Participants
Patients receive decision aids "Knowing your Options" before and "Prostate Choice" during their consultation visit.
Internet-Based Intervention: Receive "Knowing your Options" decision aid
Internet-Based Intervention: Receive "Prostate Choice" decision aid
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Survey Administration: Ancillary studies
Laboratory Biomarker Analysis: Correlative studies
|
Pre-consultation Decision Aids Only
n=38 Participants
Patients receive "Knowing your Options" decision aid before their consultation visit.
Internet-Based Intervention: Receive "Knowing your Options" decision aid
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Survey Administration: Ancillary studies
Laboratory Biomarker Analysis: Correlative studies
|
During-consultation Decision Aids Only
n=43 Participants
Patients receive "Prostate Choice" decision aid during their consultation visit.
Internet-Based Intervention: Receive "Prostate Choice" decision aid
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Survey Administration: Ancillary studies
Laboratory Biomarker Analysis: Correlative studies
|
Usual Care
n=50 Participants
Patients undergo usual care.
Best Practice: Undergo usual care
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Survey Administration: Ancillary studies
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|---|---|---|
|
Decisional Quality as Measured by Decisional Conflict Scale Decisional Regret
DCS Total Score of 1+
|
11 Participants
|
23 Participants
|
18 Participants
|
20 Participants
|
|
Decisional Quality as Measured by Decisional Conflict Scale Decisional Regret
DCS Total Score of 0
|
13 Participants
|
15 Participants
|
25 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: 12 monthsWill 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.
Outcome measures
| Measure |
Pre- and During-consultation Decision Aids
n=25 Participants
Patients receive decision aids "Knowing your Options" before and "Prostate Choice" during their consultation visit.
Internet-Based Intervention: Receive "Knowing your Options" decision aid
Internet-Based Intervention: Receive "Prostate Choice" decision aid
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Survey Administration: Ancillary studies
Laboratory Biomarker Analysis: Correlative studies
|
Pre-consultation Decision Aids Only
n=39 Participants
Patients receive "Knowing your Options" decision aid before their consultation visit.
Internet-Based Intervention: Receive "Knowing your Options" decision aid
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Survey Administration: Ancillary studies
Laboratory Biomarker Analysis: Correlative studies
|
During-consultation Decision Aids Only
n=32 Participants
Patients receive "Prostate Choice" decision aid during their consultation visit.
Internet-Based Intervention: Receive "Prostate Choice" decision aid
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Survey Administration: Ancillary studies
Laboratory Biomarker Analysis: Correlative studies
|
Usual Care
n=50 Participants
Patients undergo usual care.
Best Practice: Undergo usual care
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Survey Administration: Ancillary studies
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|---|---|---|
|
Clinical Time Required
|
27 Minutes
Interval 17.0 to 48.0
|
38 Minutes
Interval 13.0 to 150.0
|
52.5 Minutes
Interval 20.0 to 116.0
|
39.5 Minutes
Interval 13.0 to 250.0
|
SECONDARY outcome
Timeframe: 12 monthsThe 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.
Outcome measures
| Measure |
Pre- and During-consultation Decision Aids
n=25 Participants
Patients receive decision aids "Knowing your Options" before and "Prostate Choice" during their consultation visit.
Internet-Based Intervention: Receive "Knowing your Options" decision aid
Internet-Based Intervention: Receive "Prostate Choice" decision aid
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Survey Administration: Ancillary studies
Laboratory Biomarker Analysis: Correlative studies
|
Pre-consultation Decision Aids Only
n=39 Participants
Patients receive "Knowing your Options" decision aid before their consultation visit.
Internet-Based Intervention: Receive "Knowing your Options" decision aid
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Survey Administration: Ancillary studies
Laboratory Biomarker Analysis: Correlative studies
|
During-consultation Decision Aids Only
n=44 Participants
Patients receive "Prostate Choice" decision aid during their consultation visit.
Internet-Based Intervention: Receive "Prostate Choice" decision aid
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Survey Administration: Ancillary studies
Laboratory Biomarker Analysis: Correlative studies
|
Usual Care
n=50 Participants
Patients undergo usual care.
Best Practice: Undergo usual care
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Survey Administration: Ancillary studies
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|---|---|---|
|
Quality of Life Assessed by Questionnaire
Urinary Irritative
|
90.63 score on a scale
Interval 68.75 to 100.0
|
93.75 score on a scale
Interval 56.25 to 100.0
|
90.63 score on a scale
Interval 43.75 to 100.0
|
87.5 score on a scale
Interval 37.5 to 100.0
|
|
Quality of Life Assessed by Questionnaire
Urinary Incontinence
|
96.88 score on a scale
Interval 46.0 to 100.0
|
85.5 score on a scale
Interval 14.5 to 100.0
|
85.5 score on a scale
Interval 8.25 to 100.0
|
93.75 score on a scale
Interval 8.25 to 100.0
|
|
Quality of Life Assessed by Questionnaire
Bowel
|
100 score on a scale
Interval 60.0 to 100.0
|
100 score on a scale
Interval 70.83 to 100.0
|
100 score on a scale
Interval 58.33 to 100.0
|
100 score on a scale
Interval 58.33 to 100.0
|
|
Quality of Life Assessed by Questionnaire
Sexual
|
33.33 score on a scale
Interval 0.0 to 95.83
|
36.17 score on a scale
Interval 0.0 to 100.0
|
95 score on a scale
Interval 35.0 to 100.0
|
90 score on a scale
Interval 35.0 to 100.0
|
|
Quality of Life Assessed by Questionnaire
Hormonal
|
92.5 score on a scale
Interval 55.0 to 100.0
|
95 score on a scale
Interval 55.0 to 100.0
|
95 score on a scale
Interval 35.0 to 100.0
|
90 score on a scale
Interval 35.0 to 100.0
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Only includes eligible patients that reached 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.
Outcome measures
| Measure |
Pre- and During-consultation Decision Aids
n=16 Participants
Patients receive decision aids "Knowing your Options" before and "Prostate Choice" during their consultation visit.
Internet-Based Intervention: Receive "Knowing your Options" decision aid
Internet-Based Intervention: Receive "Prostate Choice" decision aid
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Survey Administration: Ancillary studies
Laboratory Biomarker Analysis: Correlative studies
|
Pre-consultation Decision Aids Only
n=38 Participants
Patients receive "Knowing your Options" decision aid before their consultation visit.
Internet-Based Intervention: Receive "Knowing your Options" decision aid
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Survey Administration: Ancillary studies
Laboratory Biomarker Analysis: Correlative studies
|
During-consultation Decision Aids Only
n=44 Participants
Patients receive "Prostate Choice" decision aid during their consultation visit.
Internet-Based Intervention: Receive "Prostate Choice" decision aid
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Survey Administration: Ancillary studies
Laboratory Biomarker Analysis: Correlative studies
|
Usual Care
n=50 Participants
Patients undergo usual care.
Best Practice: Undergo usual care
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Survey Administration: Ancillary studies
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|---|---|---|
|
Utilization as Determined by Chart Review
Active surveillance
|
4 Participants
|
9 Participants
|
15 Participants
|
16 Participants
|
|
Utilization as Determined by Chart Review
Surgery (without radiation)
|
6 Participants
|
17 Participants
|
7 Participants
|
12 Participants
|
|
Utilization as Determined by Chart Review
Radiation (without surgery)
|
5 Participants
|
5 Participants
|
10 Participants
|
18 Participants
|
|
Utilization as Determined by Chart Review
Radiation + Surgery
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Utilization as Determined by Chart Review
Treatment Choice Not Listed
|
0 Participants
|
2 Participants
|
6 Participants
|
0 Participants
|
|
Utilization as Determined by Chart Review
No Treatment (patients that submitted a month 12 form and said No to receiving treatment)
|
1 Participants
|
5 Participants
|
6 Participants
|
2 Participants
|
Adverse Events
Pre- and During-consultation Decision Aids
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Pre-consultation Decision Aids Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
During-consultation Decision Aids Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place