Prostate Cancer
Conditions
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.
Interventions
OTHERBest Practice
Undergo usual care
OTHERQuality-of-Life Assessment
Ancillary studies
OTHERQuestionnaire Administration
Ancillary studies
OTHERSurvey Administration
Ancillary studies
OTHERLaboratory Biomarker Analysis
Correlative studies
OTHERInternet-Based Intervention
Receive Knowing your Options decision aid
Sponsors
National Institute on Minority Health and Health Disparities (NIMHD)
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knowledge Assessed by Prostate Cancer Treatment Questionnaire | 12 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Decisional Quality as Measured by Decisional Regret Scale | 12 months | 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 | 12 months | 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 | 12 months | Will be categorized by the type of treatment the patient elected to receive. Will be compared across intervention arms. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 37 |
| 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 | 33 |
| 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 | 33 |
| Total | 103 |
Baseline characteristics
| Characteristic | Arm A (Knowing Your Options) | Arm B (Prostate Choice) | Arm C (Usual Care) | Total |
|---|---|---|---|---|
| Age, Continuous | 63.49 years STANDARD_DEVIATION 6.57 | 65.16 years STANDARD_DEVIATION 6.25 | 64.52 years STANDARD_DEVIATION 8.07 | 64.34 years STANDARD_DEVIATION 6.97 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 0 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 35 Participants | 30 Participants | 31 Participants | 96 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 6 Participants | 5 Participants | 6 Participants | 17 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 5 Participants | 4 Participants | 16 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 24 Participants | 22 Participants | 23 Participants | 69 Participants |
| Region of Enrollment United States | 37 Participants | 33 Participants | 33 Participants | 103 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 37 Participants | 33 Participants | 33 Participants | 103 Participants |
| Treatment Preferred Active surveillance | 5 Participants | 4 Participants | 4 Participants | 13 Participants |
| Treatment Preferred Missing | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Treatment Preferred Radiation | 9 Participants | 6 Participants | 8 Participants | 23 Participants |
| Treatment Preferred Surgery | 15 Participants | 13 Participants | 16 Participants | 44 Participants |
| Treatment Preferred Unsure | 6 Participants | 10 Participants | 5 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
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
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A (Knowing Your Options) | Knowledge Assessed by Prostate Cancer Treatment Questionnaire | 0.69 score on a scale | Standard Deviation 0.16 |
| Arm B (Prostate Choice) | Knowledge Assessed by Prostate Cancer Treatment Questionnaire | 0.69 score on a scale | Standard Deviation 0.18 |
| Arm C (Usual Care) | Knowledge Assessed by Prostate Cancer Treatment Questionnaire | 0.64 score on a scale | Standard Deviation 0.2 |
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).
Time frame: 12 months
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm A (Knowing Your Options) | Decisional Quality as Measured by Decisional Regret Scale | Decisional Regret Total score of 0 | 2 Participants |
| Arm A (Knowing Your Options) | Decisional Quality as Measured by Decisional Regret Scale | Decisional Regret Total score of 1+ | 3 Participants |
| Arm B (Prostate Choice) | Decisional Quality as Measured by Decisional Regret Scale | Decisional Regret Total score of 0 | 3 Participants |
| Arm B (Prostate Choice) | Decisional Quality as Measured by Decisional Regret Scale | Decisional Regret Total score of 1+ | 2 Participants |
| Arm C (Usual Care) | Decisional Quality as Measured by Decisional Regret Scale | Decisional Regret Total score of 0 | 2 Participants |
| Arm C (Usual Care) | Decisional Quality as Measured by Decisional Regret Scale | Decisional Regret Total score of 1+ | 5 Participants |
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.
Time frame: 12 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Arm A (Knowing Your Options) | Quality of Life Assessed by Questionnaire | Urinary Incontinence | 79.7 score on a scale |
| Arm A (Knowing Your Options) | Quality of Life Assessed by Questionnaire | Sexual | 29.4 score on a scale |
| Arm A (Knowing Your Options) | Quality of Life Assessed by Questionnaire | Bowel | 86.7 score on a scale |
| Arm A (Knowing Your Options) | Quality of Life Assessed by Questionnaire | Hormonal | 86.0 score on a scale |
| Arm A (Knowing Your Options) | Quality of Life Assessed by Questionnaire | Urinary Irritative | 80.0 score on a scale |
| Arm B (Prostate Choice) | Quality of Life Assessed by Questionnaire | Hormonal | 80.0 score on a scale |
| Arm B (Prostate Choice) | Quality of Life Assessed by Questionnaire | Urinary Incontinence | 67.2 score on a scale |
| Arm B (Prostate Choice) | Quality of Life Assessed by Questionnaire | Urinary Irritative | 90.0 score on a scale |
| Arm B (Prostate Choice) | Quality of Life Assessed by Questionnaire | Bowel | 72.9 score on a scale |
| Arm B (Prostate Choice) | Quality of Life Assessed by Questionnaire | Sexual | 35.1 score on a scale |
| Arm C (Usual Care) | Quality of Life Assessed by Questionnaire | Urinary Irritative | 83.9 score on a scale |
| Arm C (Usual Care) | Quality of Life Assessed by Questionnaire | Hormonal | 76.4 score on a scale |
| Arm C (Usual Care) | Quality of Life Assessed by Questionnaire | Sexual | 20.2 score on a scale |
| Arm C (Usual Care) | Quality of Life Assessed by Questionnaire | Urinary Incontinence | 85.8 score on a scale |
| Arm C (Usual Care) | Quality of Life Assessed by Questionnaire | Bowel | 92.3 score on a scale |
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.
Time frame: 12 months
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm A (Knowing Your Options) | Utilization as Determined by Chart Review | Radical prostatectomy | 1 Participants |
| Arm A (Knowing Your Options) | Utilization as Determined by Chart Review | Laparoscopic radical prostatectomy | 0 Participants |
| Arm A (Knowing Your Options) | Utilization as Determined by Chart Review | Robotic-assisted laparoscopic radical prostatectomy | 14 Participants |
| Arm A (Knowing Your Options) | Utilization as Determined by Chart Review | Cryosurgery | 0 Participants |
| Arm A (Knowing Your Options) | Utilization as Determined by Chart Review | Intensity modulated radiation therapy (IMRT) | 3 Participants |
| Arm A (Knowing Your Options) | Utilization as Determined by Chart Review | Brachytherapy | 4 Participants |
| Arm A (Knowing Your Options) | Utilization as Determined by Chart Review | Proton beam | 1 Participants |
| Arm A (Knowing Your Options) | Utilization as Determined by Chart Review | Hormone therapy | 4 Participants |
| Arm A (Knowing Your Options) | Utilization as Determined by Chart Review | Chemotherapy | 0 Participants |
| Arm A (Knowing Your Options) | Utilization as Determined by Chart Review | Active surveillance | 3 Participants |
| Arm B (Prostate Choice) | Utilization as Determined by Chart Review | Chemotherapy | 0 Participants |
| Arm B (Prostate Choice) | Utilization as Determined by Chart Review | Radical prostatectomy | 0 Participants |
| Arm B (Prostate Choice) | Utilization as Determined by Chart Review | Brachytherapy | 0 Participants |
| Arm B (Prostate Choice) | Utilization as Determined by Chart Review | Intensity modulated radiation therapy (IMRT) | 6 Participants |
| Arm B (Prostate Choice) | Utilization as Determined by Chart Review | Laparoscopic radical prostatectomy | 0 Participants |
| Arm B (Prostate Choice) | Utilization as Determined by Chart Review | Active surveillance | 2 Participants |
| Arm B (Prostate Choice) | Utilization as Determined by Chart Review | Hormone therapy | 4 Participants |
| Arm B (Prostate Choice) | Utilization as Determined by Chart Review | Robotic-assisted laparoscopic radical prostatectomy | 14 Participants |
| Arm B (Prostate Choice) | Utilization as Determined by Chart Review | Proton beam | 0 Participants |
| Arm B (Prostate Choice) | Utilization as Determined by Chart Review | Cryosurgery | 0 Participants |
| Arm C (Usual Care) | Utilization as Determined by Chart Review | Hormone therapy | 10 Participants |
| Arm C (Usual Care) | Utilization as Determined by Chart Review | Cryosurgery | 0 Participants |
| Arm C (Usual Care) | Utilization as Determined by Chart Review | Intensity modulated radiation therapy (IMRT) | 8 Participants |
| Arm C (Usual Care) | Utilization as Determined by Chart Review | Brachytherapy | 2 Participants |
| Arm C (Usual Care) | Utilization as Determined by Chart Review | Chemotherapy | 0 Participants |
| Arm C (Usual Care) | Utilization as Determined by Chart Review | Proton beam | 1 Participants |
| Arm C (Usual Care) | Utilization as Determined by Chart Review | Radical prostatectomy | 1 Participants |
| Arm C (Usual Care) | Utilization as Determined by Chart Review | Active surveillance | 1 Participants |
| Arm C (Usual Care) | Utilization as Determined by Chart Review | Laparoscopic radical prostatectomy | 0 Participants |
| Arm C (Usual Care) | Utilization as Determined by Chart Review | Robotic-assisted laparoscopic radical prostatectomy | 12 Participants |