Trial Outcomes & Findings for Decision Aids to Improve Knowledge in Patients With Prostate Cancer (NCT NCT03182998)
NCT ID: NCT03182998
Last Updated: 2023-08-02
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 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
COMPLETED
NA
103 participants
12 months
2023-08-02
Participant Flow
Participant milestones
| Measure |
Arm A (Knowing Your Options)
Arm A ("Knowing your Options") 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
|
Arm B (Prostate Choice)
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
|
Arm C (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
|
37
|
33
|
33
|
|
Overall Study
COMPLETED
|
36
|
33
|
33
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Decision Aids to Improve Knowledge in Patients With Prostate Cancer
Baseline characteristics by cohort
| Measure |
Arm A (Knowing Your Options)
n=37 Participants
Arm A ("Knowing your Options") 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
|
Arm B (Prostate Choice)
n=33 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
|
Arm C (Usual Care)
n=33 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=103 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
63.49 years
STANDARD_DEVIATION 6.57 • n=99 Participants
|
65.16 years
STANDARD_DEVIATION 6.25 • n=107 Participants
|
64.52 years
STANDARD_DEVIATION 8.07 • n=206 Participants
|
64.34 years
STANDARD_DEVIATION 6.97 • n=7 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
103 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
96 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
17 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
16 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
69 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
37 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
103 Participants
n=7 Participants
|
|
Treatment Preferred
Surgery
|
15 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
44 Participants
n=7 Participants
|
|
Treatment Preferred
Radiation
|
9 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
23 Participants
n=7 Participants
|
|
Treatment Preferred
Active surveillance
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
|
Treatment Preferred
Unsure
|
6 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
21 Participants
n=7 Participants
|
|
Treatment Preferred
Missing
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 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 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
Outcome measures
| Measure |
Arm A (Knowing Your Options)
n=36 Participants
Arm A ("Knowing your Options") 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
|
Arm B (Prostate Choice)
n=33 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
|
Arm C (Usual Care)
n=33 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 score on a scale
Standard Deviation 0.16
|
0.69 score on a scale
Standard Deviation 0.18
|
0.64 score on a scale
Standard Deviation 0.20
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Secondary outcomes were to be based on data collected at 12 months. Two of our sites (enrolling \>50% of study participants) experienced staff turnover and/or loss of contact with participants. As a result, we lost our ability and opportunity to maintain contact with nearly all participants at both sites and were unable to collect secondary outcome data at 12 months. Results reported here reflect the data we were able to collect.
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).
Outcome measures
| Measure |
Arm A (Knowing Your Options)
n=5 Participants
Arm A ("Knowing your Options") 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
|
Arm B (Prostate Choice)
n=5 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
|
Arm C (Usual Care)
n=7 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 Regret Scale
Decisional Regret Total score of 0
|
2 Participants
|
3 Participants
|
2 Participants
|
|
Decisional Quality as Measured by Decisional Regret Scale
Decisional Regret Total score of 1+
|
3 Participants
|
2 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Secondary outcomes were to be based on data collected at 12 months. Two of our sites (enrolling \>50% of study participants) experienced staff turnover and/or loss of contact with participants. As a result, we lost our ability and opportunity to maintain contact with nearly all participants at both sites and were unable to collect secondary outcome data at 12 months. Results reported here reflect the data we were able to collect.
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.
Outcome measures
| Measure |
Arm A (Knowing Your Options)
n=5 Participants
Arm A ("Knowing your Options") 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
|
Arm B (Prostate Choice)
n=6 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
|
Arm C (Usual Care)
n=7 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 Incontinence
|
79.7 score on a scale
Interval 58.5 to 100.0
|
67.2 score on a scale
Interval 16.5 to 93.8
|
85.8 score on a scale
Interval 60.5 to 100.0
|
|
Quality of Life Assessed by Questionnaire
Urinary Irritative
|
80.0 score on a scale
Interval 43.8 to 93.8
|
90.0 score on a scale
Interval 81.2 to 100.0
|
83.9 score on a scale
Interval 56.2 to 100.0
|
|
Quality of Life Assessed by Questionnaire
Bowel
|
86.7 score on a scale
Interval 62.5 to 100.0
|
72.9 score on a scale
Interval 29.2 to 100.0
|
92.3 score on a scale
Interval 58.3 to 100.0
|
|
Quality of Life Assessed by Questionnaire
Sexual
|
29.4 score on a scale
Interval 0.0 to 70.8
|
35.1 score on a scale
Interval 12.5 to 73.7
|
20.2 score on a scale
Interval 16.7 to 27.8
|
|
Quality of Life Assessed by Questionnaire
Hormonal
|
86.0 score on a scale
Interval 60.0 to 100.0
|
80.0 score on a scale
Interval 60.0 to 95.0
|
76.4 score on a scale
Interval 60.0 to 100.0
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Secondary outcomes were to be based on data collected at 12 months. Treatment choice could be ascertained immediately upon patient treatment selection. Two of our sites (enrolling \>50% of study participants) experienced staff turnover and/or loss of contact with participants. As a result, we lost our ability and opportunity to maintain contact with several participants and were unable to collect treatment choice for all participants. Results reported reflect the data we were able to collect.
Will be categorized by the type of treatment the patient elected to receive. Will be compared across intervention arms.
Outcome measures
| Measure |
Arm A (Knowing Your Options)
n=26 Participants
Arm A ("Knowing your Options") 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
|
Arm B (Prostate Choice)
n=21 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
|
Arm C (Usual Care)
n=24 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
Brachytherapy
|
4 Participants
|
0 Participants
|
2 Participants
|
|
Utilization as Determined by Chart Review
Radical prostatectomy
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Utilization as Determined by Chart Review
Laparoscopic radical prostatectomy
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Utilization as Determined by Chart Review
Robotic-assisted laparoscopic radical prostatectomy
|
14 Participants
|
14 Participants
|
12 Participants
|
|
Utilization as Determined by Chart Review
Cryosurgery
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Utilization as Determined by Chart Review
Intensity modulated radiation therapy (IMRT)
|
3 Participants
|
6 Participants
|
8 Participants
|
|
Utilization as Determined by Chart Review
Proton beam
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Utilization as Determined by Chart Review
Hormone therapy
|
4 Participants
|
4 Participants
|
10 Participants
|
|
Utilization as Determined by Chart Review
Chemotherapy
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Utilization as Determined by Chart Review
Active surveillance
|
3 Participants
|
2 Participants
|
1 Participants
|
Adverse Events
Arm A (Knowing Your Options)
Arm B (Prostate Choice)
Arm C (Usual Care)
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