Prostate Cancer
Conditions
Brief summary
Black men are disproportionately affected by prostate cancer, the most common non-cutaneous malignancy among men in the U.S. This randomized trial will evaluate the efficacy of a Community Health Worker-led decision coaching program to facilitate Shared Decision Making (SDM) and Prostate Specific Antigen (PSA) screening among Black men with regards to decision quality, the decision making process, patient-provider communication and PSA utilization for Black men in the primary care setting.
Interventions
counseling from extensively trained CHW
coaching using an educational tool focused on dietary and lifestyle modification
Sponsors
Study design
Eligibility
Inclusion criteria
Patients: * Black * Male * Attending FQHC for routine primary care appointment Providers: * Provider at Sunset Park Health Council Federally Qualified Health Center (FQHC) * Caring for patients that fit inclusion criteria
Exclusion criteria
* Provider at Sunset Park Health Council Federally Qualified Health Center (FQHC) * Caring for patients that fit inclusion criteria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prostate Specific Antigen (PSA) Screening Rates | Up to Month 3 | Percentage of participants who receive at least one PSA screening. Screening data are collected through patient self-reports and electronic health record data. |
| Patient Knowledge Survey Score | Day 1 | The Patient Knowledge Survey comprises 12 items assessing participants' understanding of PSA testing and prostate cancer. Respondents provide an answer of True, Unsure, or False. The total score is the sum of correct responses and ranges from 0-12; higher scores indicate greater knowledge. |
| Decision Quality Score | Day 1 | Scale consists of 12 items assessing participants' attitudes toward prostate cancer treatment and screening (6 Pros and 6 Cons of testing) scored on a 5 point Likert scale (Strongly Disagree to Strongly Agree). The total score is the sum of responses and ranges from -24 to +24; Positive scores indicate a more favorable assessment of the pros versus the cons of the test.This survey will be administered twice: once directly following the coaching session prior to the patient's appointment, and again following the appointment. |
| Percentage of Participants Who Make Informed Choice | Day 1 | Percentage of participants who made an Informed Choice to either undergo or decline PSA testing. Informed choices are those in which: 1\. Men with good knowledge and positive measure of informed choice attitudes (\> or = 22) choose to undergo the test OR 2) Men with good knowledge but negative measure of informed choice attitudes (\<22) towards the test, do not undergo the test The Measure of Informed Choice Attitudes survey is administered twice: once directly following the coaching session prior to the patient's appointment, and again following the appointment and the patient's screening decision is recorded during post-appointment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction With Decision Scale Score | Day 1 | 6-item assessment of participants' satisfaction with their prostate cancer screening decisions. Each item is rated on a 1-5 scale, where 1 = strongly disagree and 5 = strongly agree. The total score is the average of all items and ranges from 1-5. Higher scores indicate greater satisfaction with decision. |
| Change in Decisional Conflict Scale Score | Day 1 | The Decisional Conflict Scale is a 16-item survey assessing the level of decisional conflict for participants when deciding whether to have prostate cancer screening. Each item is rated on a 0-4 scale, where 0 = strongly agree and 4 = strongly disagree. The total score is the sum of responses and ranges from 0 to 64. Scores lower than 25 are associated with implementing decisions; scores exceeding 37.5 are associated with decision delay or feeling unsure about implementation. |
| Decisional Regret Scale Survey | Month 6 | 5-item assessment of participants' regret toward the first decision they made about prostate cancer screening after speaking with their provider. Each item is rated on a scale from 1-5, where 1 = strongly agree and 5 = strongly disagree. The total score is the sum of responses and ranges from 5 to 25. Higher scores indicate greater regret. To help others interpret the score more readily with other scales ranging from 0 to 100, these scores can then be converted to a 0-100 scale by subtracting 1 from each item then multiply by 25. To obtain a final score, the items are summed and averaged. The final score presented ranges from 0 to 100, higher scores indicate greater regret. |
| Decision Self-Efficacy Scale Score | Day 1 | The Decision Self-Efficacy Scale is an 11-item survey measuring confidence in making an informed choice. Each item is rated on a scale from 0-4, where 0 = not at all confident and 4 = very confident. The raw score is the sum of responses and is transformed to a standard total score ranging from 0 to 100; higher scores indicate extremely high self-efficacy. |
| Doctor-Patient Communication Survey Score | Day 1 | The Doctor-Patient Communication Survey includes 19 items assessing how participants felt they were able to communicate with their provider. Each item is rated on a scale from 1-5, where 1 = strongly disagree and 5 = strongly agree. The total score is the average score of responses and ranges from 0 to 5; higher scores indicate greater doctor-patient communication. |
| Perceived Efficacy in Patient-Physician Interactions Questionnaire (PEPPI) Score | Day 1 | PEPPI is a 10-item assessment of participant's perceived self-efficacy for communicating with their provider. Each item is rated on a scale from 1-5, where 1 = not at all confident and 5 = very confident. The total score is the sum of responses and ranges from 10 to 50; higher scores indicate greater self-efficacy in communicating with providers. |
Countries
United States
Participant flow
Pre-assignment details
Participants in the Patient Providers arm were not assigned to an intervention/control condition. Rather, these providers treated patient participants assigned to both the intervention group and the control group. As such, Participant Flow data on the Patient Provider participants is presented in 1 arm.
Participants by arm
| Arm | Count |
|---|---|
| Intervention Group: Patients A decision aid along with decision coaching on PSA screening from a Community Health Worker (CHW). The intervention will be administered directly prior to the participant's appointment with their provider.
Education Counseling Session for PSA Screening: counseling from extensively trained CHW | 54 |
| Control Group: Patients A decision aid along with CHW interaction on dietary and lifestyle modification to serve as an attention control. The intervention will be administered directly prior to the participant's appointment with their provider.
General Health Counseling Coaching: coaching using an educational tool focused on dietary and lifestyle modification | 60 |
| Patient Providers Patient provider participants included patients' physicians/nurse practitioners. | 12 |
| Total | 126 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Clinic / insurance issue | 2 | 0 | 0 |
| Overall Study | Ineligible after enrollment | 3 | 3 | 0 |
| Overall Study | Language barrier | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 2 | 4 | 0 |
| Overall Study | Provider left the clinic | 0 | 0 | 1 |
| Overall Study | Time Constraints | 4 | 1 | 0 |
Baseline characteristics
| Characteristic | Intervention Group: Patients | Total | Patient Providers | Control Group: Patients |
|---|---|---|---|---|
| Age, Continuous | 53.2 years STANDARD_DEVIATION 8.72 | 49.87 years STANDARD_DEVIATION 8.82 | 41.7 years STANDARD_DEVIATION 10.1 | 54.7 years STANDARD_DEVIATION 7.63 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 3 Participants | 2 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 10 Participants | 10 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 54 Participants | 113 Participants | 0 Participants | 59 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 54 Participants | 118 Participants | 4 Participants | 60 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 | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 3 Participants | 3 Participants | 0 Participants |
| Region of Enrollment United States | 54 participants | 126 participants | 12 participants | 60 participants |
| Sex: Female, Male Female | 0 Participants | 8 Participants | 8 Participants | 0 Participants |
| Sex: Female, Male Male | 54 Participants | 117 Participants | 3 Participants | 60 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 54 | 0 / 60 |
| other Total, other adverse events | 0 / 54 | 0 / 60 |
| serious Total, serious adverse events | 0 / 54 | 0 / 60 |
Outcome results
Decision Quality Score
Scale consists of 12 items assessing participants' attitudes toward prostate cancer treatment and screening (6 Pros and 6 Cons of testing) scored on a 5 point Likert scale (Strongly Disagree to Strongly Agree). The total score is the sum of responses and ranges from -24 to +24; Positive scores indicate a more favorable assessment of the pros versus the cons of the test.This survey will be administered twice: once directly following the coaching session prior to the patient's appointment, and again following the appointment.
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Decision Quality Score | 11.2 score on a scale | Standard Deviation 5.42 |
| Control Group | Decision Quality Score | 10.8 score on a scale | Standard Deviation 3.99 |
Patient Knowledge Survey Score
The Patient Knowledge Survey comprises 12 items assessing participants' understanding of PSA testing and prostate cancer. Respondents provide an answer of True, Unsure, or False. The total score is the sum of correct responses and ranges from 0-12; higher scores indicate greater knowledge.
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Patient Knowledge Survey Score | 8.13 score on a scale | Standard Deviation 1.33 |
| Control Group | Patient Knowledge Survey Score | 5.23 score on a scale | Standard Deviation 2.24 |
Percentage of Participants Who Make Informed Choice
Percentage of participants who made an Informed Choice to either undergo or decline PSA testing. Informed choices are those in which: 1\. Men with good knowledge and positive measure of informed choice attitudes (\> or = 22) choose to undergo the test OR 2) Men with good knowledge but negative measure of informed choice attitudes (\<22) towards the test, do not undergo the test The Measure of Informed Choice Attitudes survey is administered twice: once directly following the coaching session prior to the patient's appointment, and again following the appointment and the patient's screening decision is recorded during post-appointment.
Time frame: Day 1
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Group | Percentage of Participants Who Make Informed Choice | 64.8 Percentage of participants |
| Control Group | Percentage of Participants Who Make Informed Choice | 43.3 Percentage of participants |
Prostate Specific Antigen (PSA) Screening Rates
Percentage of participants who receive at least one PSA screening. Screening data are collected through patient self-reports and electronic health record data.
Time frame: Up to Month 3
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Group | Prostate Specific Antigen (PSA) Screening Rates | 77.8 Percentage of participants |
| Control Group | Prostate Specific Antigen (PSA) Screening Rates | 76.7 Percentage of participants |
Change in Decisional Conflict Scale Score
The Decisional Conflict Scale is a 16-item survey assessing the level of decisional conflict for participants when deciding whether to have prostate cancer screening. Each item is rated on a 0-4 scale, where 0 = strongly agree and 4 = strongly disagree. The total score is the sum of responses and ranges from 0 to 64. Scores lower than 25 are associated with implementing decisions; scores exceeding 37.5 are associated with decision delay or feeling unsure about implementation.
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Change in Decisional Conflict Scale Score | 17 score on a scale | Standard Deviation 11 |
| Control Group | Change in Decisional Conflict Scale Score | 21.9 score on a scale | Standard Deviation 13.2 |
Decisional Regret Scale Survey
5-item assessment of participants' regret toward the first decision they made about prostate cancer screening after speaking with their provider. Each item is rated on a scale from 1-5, where 1 = strongly agree and 5 = strongly disagree. The total score is the sum of responses and ranges from 5 to 25. Higher scores indicate greater regret. To help others interpret the score more readily with other scales ranging from 0 to 100, these scores can then be converted to a 0-100 scale by subtracting 1 from each item then multiply by 25. To obtain a final score, the items are summed and averaged. The final score presented ranges from 0 to 100, higher scores indicate greater regret.
Time frame: Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Decisional Regret Scale Survey | 21.2 score on a scale | Standard Deviation 15.3 |
| Control Group | Decisional Regret Scale Survey | 27 score on a scale | Standard Deviation 18.2 |
Decision Self-Efficacy Scale Score
The Decision Self-Efficacy Scale is an 11-item survey measuring confidence in making an informed choice. Each item is rated on a scale from 0-4, where 0 = not at all confident and 4 = very confident. The raw score is the sum of responses and is transformed to a standard total score ranging from 0 to 100; higher scores indicate extremely high self-efficacy.
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Decision Self-Efficacy Scale Score | 96 score on a scale | Standard Deviation 8.41 |
| Control Group | Decision Self-Efficacy Scale Score | 94.7 score on a scale | Standard Deviation 9.15 |
Doctor-Patient Communication Survey Score
The Doctor-Patient Communication Survey includes 19 items assessing how participants felt they were able to communicate with their provider. Each item is rated on a scale from 1-5, where 1 = strongly disagree and 5 = strongly agree. The total score is the average score of responses and ranges from 0 to 5; higher scores indicate greater doctor-patient communication.
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Doctor-Patient Communication Survey Score | 4.28 score on a scale | Standard Deviation 0.395 |
| Control Group | Doctor-Patient Communication Survey Score | 4.31 score on a scale | Standard Deviation 0.412 |
Perceived Efficacy in Patient-Physician Interactions Questionnaire (PEPPI) Score
PEPPI is a 10-item assessment of participant's perceived self-efficacy for communicating with their provider. Each item is rated on a scale from 1-5, where 1 = not at all confident and 5 = very confident. The total score is the sum of responses and ranges from 10 to 50; higher scores indicate greater self-efficacy in communicating with providers.
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Perceived Efficacy in Patient-Physician Interactions Questionnaire (PEPPI) Score | 47.5 score on a scale | Standard Deviation 4.86 |
| Control Group | Perceived Efficacy in Patient-Physician Interactions Questionnaire (PEPPI) Score | 47.3 score on a scale | Standard Deviation 4.4 |
Satisfaction With Decision Scale Score
6-item assessment of participants' satisfaction with their prostate cancer screening decisions. Each item is rated on a 1-5 scale, where 1 = strongly disagree and 5 = strongly agree. The total score is the average of all items and ranges from 1-5. Higher scores indicate greater satisfaction with decision.
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Satisfaction With Decision Scale Score | 4.48 score on a scale | Standard Deviation 0.48 |
| Control Group | Satisfaction With Decision Scale Score | 4.31 score on a scale | Standard Deviation 0.539 |