PSA Level Five to Ten, PSA Level Less Than Five, PSA Level Ten to Fifty, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer, Stage III Prostate Cancer, Stage II Prostate Cancer, Stage I Prostate Cancer
Conditions
Brief summary
This randomized phase III trial studies how well decision aids work in improving knowledge in patients with newly diagnosed prostate cancer. Decision aids may improve patients' knowledge of their condition and options for treatment, and may also help when talking with their doctor.
Detailed description
PRIMARY OBJECTIVES: I. To test the comparative effectiveness of decision aids (DA's) on patient knowledge. SECONDARY OBJECTIVES: I. To test the impact of in-visit DA's alone compared to usual care on quality of life outcomes and treatment utilization. II. To test the impact of out-of-visit DA's alone compared to usual care on quality of life outcomes and treatment utilization. III. To test the impact of combined in-visit and out-of-visit DA's compared to both usual care and individual DAs on quality of life outcomes and treatment utilization. IV. To test the comparative effectiveness of DA's on minority men's knowledge. V. To compare clinic time required to administer the DA's across arms. OUTLINE: Patients are randomized into 1 of 4 arms. ARM A: Patients receive decision aids Knowing your Options before and Prostate Choice during their consultation visit. ARM B: Patients receive Knowing your Options decision aid before their consultation visit. ARM C: Patients receive Prostate Choice decision aid during their consultation visit. ARM D: Patients undergo usual care. After completion of study, patients are followed up at 12 months.
Interventions
OTHERInternet-Based Intervention
Receive Knowing your Options decision aid
OTHERBest Practice
Undergo usual care
OTHERQuality-of-Life Assessment
Ancillary studies
OTHERQuestionnaire Administration
Ancillary studies
OTHERSurvey Administration
Ancillary studies
OTHERLaboratory Biomarker Analysis
Correlative studies
Sponsors
National Cancer Institute (NCI)
Alliance for Clinical Trials in Oncology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
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 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Decisional Quality as Measured by Decisional Conflict Scale Decisional Regret | 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 median scores for each cohort were grouped into two categories, 0(no regret) and 1+(at least some regret). |
| Clinical Time Required | 12 months | 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. |
| Quality of Life Assessed by Questionnaire | 12 months | The 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. |
| Utilization as Determined by Chart Review | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 25 |
| 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 | 39 |
| 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 | 44 |
| 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 | 50 |
| Total | 158 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Protocol Violation | 1 | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | Pre- and During-consultation Decision Aids | Pre-consultation Decision Aids Only | During-consultation Decision Aids Only | Usual Care | Total |
|---|---|---|---|---|---|
| Age, Continuous | 62.5 years STANDARD_DEVIATION 7.33 | 63.1 years STANDARD_DEVIATION 8.09 | 64.6 years STANDARD_DEVIATION 7.46 | 63.4 years STANDARD_DEVIATION 7.87 | 63.5 years STANDARD_DEVIATION 7.69 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 2 Participants | 0 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants | 37 Participants | 38 Participants | 47 Participants | 147 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 4 Participants | 3 Participants | 8 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 25 Participants | 39 Participants | 44 Participants | 50 Participants | 158 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 1 / 38 | 1 / 43 | 0 / 50 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 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 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
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pre- and During-consultation Decision Aids | Knowledge Assessed by Prostate Cancer Treatment Questionnaire | 0.69 percentage of items correct | Standard Deviation 0.165 |
| Pre-consultation Decision Aids Only | Knowledge Assessed by Prostate Cancer Treatment Questionnaire | 0.65 percentage of items correct | Standard Deviation 0.164 |
| During-consultation Decision Aids Only | Knowledge Assessed by Prostate Cancer Treatment Questionnaire | 0.58 percentage of items correct | Standard Deviation 0.167 |
| Usual Care | Knowledge Assessed by Prostate Cancer Treatment Questionnaire | 0.56 percentage of items correct | Standard Deviation 0.232 |
Secondary
Clinical Time Required
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.
Time frame: 12 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pre- and During-consultation Decision Aids | Clinical Time Required | 27 Minutes |
| Pre-consultation Decision Aids Only | Clinical Time Required | 38 Minutes |
| During-consultation Decision Aids Only | Clinical Time Required | 52.5 Minutes |
| Usual Care | Clinical Time Required | 39.5 Minutes |
Secondary
Decisional Quality as Measured by Decisional Conflict Scale Decisional Regret
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 median scores for each cohort were grouped into two categories, 0(no regret) and 1+(at least some regret).
Time frame: 12 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pre- and During-consultation Decision Aids | Decisional Quality as Measured by Decisional Conflict Scale Decisional Regret | DCS Total Score of 0 | 13 Participants |
| Pre- and During-consultation Decision Aids | Decisional Quality as Measured by Decisional Conflict Scale Decisional Regret | DCS Total Score of 1+ | 11 Participants |
| Pre-consultation Decision Aids Only | Decisional Quality as Measured by Decisional Conflict Scale Decisional Regret | DCS Total Score of 1+ | 23 Participants |
| Pre-consultation Decision Aids Only | Decisional Quality as Measured by Decisional Conflict Scale Decisional Regret | DCS Total Score of 0 | 15 Participants |
| During-consultation Decision Aids Only | Decisional Quality as Measured by Decisional Conflict Scale Decisional Regret | DCS Total Score of 0 | 25 Participants |
| During-consultation Decision Aids Only | Decisional Quality as Measured by Decisional Conflict Scale Decisional Regret | DCS Total Score of 1+ | 18 Participants |
| Usual Care | Decisional Quality as Measured by Decisional Conflict Scale Decisional Regret | DCS Total Score of 0 | 30 Participants |
| Usual Care | Decisional Quality as Measured by Decisional Conflict Scale Decisional Regret | DCS Total Score of 1+ | 20 Participants |
Secondary
Quality of Life Assessed by Questionnaire
The 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.
Time frame: 12 months
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Pre- and During-consultation Decision Aids | Quality of Life Assessed by Questionnaire | Sexual | 33.33 score on a scale |
| Pre- and During-consultation Decision Aids | Quality of Life Assessed by Questionnaire | Urinary Incontinence | 96.88 score on a scale |
| Pre- and During-consultation Decision Aids | Quality of Life Assessed by Questionnaire | Hormonal | 92.5 score on a scale |
| Pre- and During-consultation Decision Aids | Quality of Life Assessed by Questionnaire | Bowel | 100 score on a scale |
| Pre- and During-consultation Decision Aids | Quality of Life Assessed by Questionnaire | Urinary Irritative | 90.63 score on a scale |
| Pre-consultation Decision Aids Only | Quality of Life Assessed by Questionnaire | Bowel | 100 score on a scale |
| Pre-consultation Decision Aids Only | Quality of Life Assessed by Questionnaire | Sexual | 36.17 score on a scale |
| Pre-consultation Decision Aids Only | Quality of Life Assessed by Questionnaire | Hormonal | 95 score on a scale |
| Pre-consultation Decision Aids Only | Quality of Life Assessed by Questionnaire | Urinary Incontinence | 85.5 score on a scale |
| Pre-consultation Decision Aids Only | Quality of Life Assessed by Questionnaire | Urinary Irritative | 93.75 score on a scale |
| During-consultation Decision Aids Only | Quality of Life Assessed by Questionnaire | Bowel | 100 score on a scale |
| During-consultation Decision Aids Only | Quality of Life Assessed by Questionnaire | Urinary Irritative | 90.63 score on a scale |
| During-consultation Decision Aids Only | Quality of Life Assessed by Questionnaire | Urinary Incontinence | 85.5 score on a scale |
| During-consultation Decision Aids Only | Quality of Life Assessed by Questionnaire | Sexual | 95 score on a scale |
| During-consultation Decision Aids Only | Quality of Life Assessed by Questionnaire | Hormonal | 95 score on a scale |
| Usual Care | Quality of Life Assessed by Questionnaire | Sexual | 90 score on a scale |
| Usual Care | Quality of Life Assessed by Questionnaire | Urinary Incontinence | 93.75 score on a scale |
| Usual Care | Quality of Life Assessed by Questionnaire | Urinary Irritative | 87.5 score on a scale |
| Usual Care | Quality of Life Assessed by Questionnaire | Bowel | 100 score on a scale |
| Usual Care | Quality of Life Assessed by Questionnaire | Hormonal | 90 score on a scale |
Secondary
Utilization as Determined by Chart Review
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.
Time frame: 12 months
Population: Only includes eligible patients that reached 12 months.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pre- and During-consultation Decision Aids | Utilization as Determined by Chart Review | Active surveillance | 4 Participants |
| Pre- and During-consultation Decision Aids | Utilization as Determined by Chart Review | Surgery (without radiation) | 6 Participants |
| Pre- and During-consultation Decision Aids | Utilization as Determined by Chart Review | Radiation (without surgery) | 5 Participants |
| Pre- and During-consultation Decision Aids | Utilization as Determined by Chart Review | Radiation + Surgery | 0 Participants |
| Pre- and During-consultation Decision Aids | Utilization as Determined by Chart Review | Treatment Choice Not Listed | 0 Participants |
| Pre- and During-consultation Decision Aids | Utilization as Determined by Chart Review | No Treatment (patients that submitted a month 12 form and said No to receiving treatment) | 1 Participants |
| Pre-consultation Decision Aids Only | Utilization as Determined by Chart Review | No Treatment (patients that submitted a month 12 form and said No to receiving treatment) | 5 Participants |
| Pre-consultation Decision Aids Only | Utilization as Determined by Chart Review | Radiation + Surgery | 0 Participants |
| Pre-consultation Decision Aids Only | Utilization as Determined by Chart Review | Active surveillance | 9 Participants |
| Pre-consultation Decision Aids Only | Utilization as Determined by Chart Review | Radiation (without surgery) | 5 Participants |
| Pre-consultation Decision Aids Only | Utilization as Determined by Chart Review | Surgery (without radiation) | 17 Participants |
| Pre-consultation Decision Aids Only | Utilization as Determined by Chart Review | Treatment Choice Not Listed | 2 Participants |
| During-consultation Decision Aids Only | Utilization as Determined by Chart Review | Surgery (without radiation) | 7 Participants |
| During-consultation Decision Aids Only | Utilization as Determined by Chart Review | Radiation (without surgery) | 10 Participants |
| During-consultation Decision Aids Only | Utilization as Determined by Chart Review | Radiation + Surgery | 0 Participants |
| During-consultation Decision Aids Only | Utilization as Determined by Chart Review | No Treatment (patients that submitted a month 12 form and said No to receiving treatment) | 6 Participants |
| During-consultation Decision Aids Only | Utilization as Determined by Chart Review | Treatment Choice Not Listed | 6 Participants |
| During-consultation Decision Aids Only | Utilization as Determined by Chart Review | Active surveillance | 15 Participants |
| Usual Care | Utilization as Determined by Chart Review | Treatment Choice Not Listed | 0 Participants |
| Usual Care | Utilization as Determined by Chart Review | No Treatment (patients that submitted a month 12 form and said No to receiving treatment) | 2 Participants |
| Usual Care | Utilization as Determined by Chart Review | Surgery (without radiation) | 12 Participants |
| Usual Care | Utilization as Determined by Chart Review | Radiation + Surgery | 2 Participants |
| Usual Care | Utilization as Determined by Chart Review | Active surveillance | 16 Participants |
| Usual Care | Utilization as Determined by Chart Review | Radiation (without surgery) | 18 Participants |