Prostate Cancer
Conditions
Keywords
Prostate cancer, Primary Care, PSA-screening, African American males
Brief summary
This behavioral clinical trial assesses the efficacy of a educational intervention to increase shared decision making about prostate-specific antigen (PSA)-based screening for prostate cancer among African American males. Half of participants will receive a multimedia educational intervention, while the other half will receive usual care.
Detailed description
The 2018 U.S. Preventive Services Task Force (USPSTF) final recommendation states that male patients and their providers engage in a shared-decision making process about the benefits and harms of PSA-based screening. As characterized by the USPSTF, these conversations are particularly important for African American men given increased ambiguity due to the lack of PSA-based research specific to this population and increased risk of prostate cancer mortality attributed to late stage at diagnosis and more aggressive prostate cancer phenotypes seen in African American men. The goal of this randomized behavioral clinical trial is to advance the translation path of implementing the decision-making process in clinical encounters by evaluating the efficacy of an educational intervention for African American males to increase shared decision making about PSA-screening versus usual care. The intervention will use multimedia educational training materials to increase understanding of prostate cancer, PSA-based screening, and shared decision making among patients and their primary care providers (PCPs).
Interventions
BEHAVIORALEducational Shared Decision-Making Intervention
The intervention includes a web-based patients' decision aid about PSA-based prostate cancer screening, risks and preferences. The providers receive a summary of the USPSTF 2018 guidelines and main components of the Agency for Healthcare Research and Quality (AHRQ) SHARE curriculum, a link to a video of a prototypical shared decision making conversation, and a laminated shared decision making reminder card.
Sponsors
Tulane University
National Institute on Minority Health and Health Disparities (NIMHD)
Xavier University of Louisiana.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Caregiver)
Masking description
The patients are the unit of randomization and physicians do not know what patients are assigned to the intervention or control arm.
Intervention model description
Parallel assignment
Eligibility
Sex/Gender
MALE
Age
40 Years to 69 Years
Healthy volunteers
Yes
Inclusion criteria
Patient Inclusion Criteria: * Receiving care at the clinical sites * Identify as African American male * Ages 40-69 years old Patient
Exclusion criteria
* Personal history of prostate cancer at the time of consent * Cognitive impairment that would interfere with participation in the study * Unable to complete any aspect of the intervention within the specified time limit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Shared Decision-making | One month after audio-recorded visit | The Observing Patient Involvement (OPTION) Scale was used for the coding of the SDM. The total OPTION scale ranges from 0 to 48. Higher values on the scale mean higher patient involvement in the decision-making process. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Decision (QD) | Up to 24 weeks after the audio-recorded visit | The total QD score ranges from 0 to 100. Higher percentage scores mean higher quality of the decision made. |
| Preference-Congruent Decision Making | Through study completion, an average of 1 year | The Intention-to-Screen score ranges from 0 to 1. Score = 0 means no intention to receive the PSA test while score = 1 means intention to receive the PSA test. Preference-concordant decision making will be scored as 1 (POSITIVE) for those patients with Intention-to-Screen value = 1 who actually receive the PSA test during the study timeframe, or for those patients with Intention-to-Screen value = 0 who did not receive it. Preference-concordant decision making will be scored as 0 (NEGATIVE) for those patients with Intention-to-Screen value = 1 who did not receive the PSA test during the study timeframe, or for those patients with Intention-to-Screen value = 0 who did receive it. A congruence score of 1 means congruence between patient intention and real action, while a congruence score of 0 means patient in congruence between intention and real action. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Acceptability | Through study completion, an average of 1 year | Participants complete a structured questionnaire to rate the acceptability of the enrollment process, study procedures, and their overall satisfaction with the study. The score ranges from 10 to 50. Higher scores mean higher acceptability of study procedures. |
Countries
United States
Participant flow
Recruitment details
Prospective participants were identified through the medical records and were invited to participate in the study. Those willing to participate were enrolled in the study after signing the consent and HIPPA forms. Participants were had the option to opt out of the study anytime.
Pre-assignment details
After completing the baseline, participants were assigned randomly to the intervention or control arms
Participants by arm
| Arm | Count |
|---|---|
| Intervention Patients in the intervention will receive the educational intervention
Educational Shared Decision-Making Intervention: The intervention includes a web-based patients' decision aid about PSA-based prostate cancer screening, risks and preferences. The providers receive a summary of the USPSTF 2018 guidelines and main components of the Agency for Healthcare Research and Quality (AHRQ) SHARE curriculum, a link to a video of a prototypical shared decision making conversation, and a laminated shared decision making reminder card. | 79 |
| Usual Care Patients in the control arm will receive usual care | 76 |
| Total | 155 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Changed clinical site or moved out of city | 5 | 9 |
| Overall Study | Death | 1 | 1 |
| Overall Study | Lost to Follow-up | 3 | 12 |
| Overall Study | No primary care appointment scheduled | 10 | 4 |
| Overall Study | prostate removed during the study | 1 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Intervention | Usual Care | Total |
|---|---|---|---|
| Age, Customized 40-49 years old | 10 Participants | 18 Participants | 28 Participants |
| Age, Customized 50-59 years old | 30 Participants | 27 Participants | 57 Participants |
| Age, Customized 60-69 years old | 39 Participants | 31 Participants | 70 Participants |
| Participants with a family history of prostate cancer Have family history | 13 Participants | 18 Participants | 31 Participants |
| Participants with a family history of prostate cancer No family history | 66 Participants | 58 Participants | 124 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 79 Participants | 76 Participants | 155 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 79 participants | 76 participants | 155 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 79 Participants | 76 Participants | 155 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 79 | 1 / 76 |
| other Total, other adverse events | 0 / 79 | 0 / 76 |
| serious Total, serious adverse events | 0 / 79 | 0 / 76 |
Outcome results
Primary
Shared Decision-making
The Observing Patient Involvement (OPTION) Scale was used for the coding of the SDM. The total OPTION scale ranges from 0 to 48. Higher values on the scale mean higher patient involvement in the decision-making process.
Time frame: One month after audio-recorded visit
Population: The OPTION Scale was applied only to patients who had attended the medical appointment (62 in the intervention group, and 64 in the control group). Because one recording in the control group could not be completed (the audio-recording device was damaged), only 63 recordings were evaluated in that group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Shared Decision-making | 12.54 Units on a scale | Standard Deviation 11.0198 |
| Usual Care | Shared Decision-making | 12.15 Units on a scale | Standard Deviation 10.4026 |
Comparison: H0:muI = muCp-value: 0.838895% CI: [-3.4, 4.19]t-test, 2 sided
Secondary
Preference-Congruent Decision Making
The Intention-to-Screen score ranges from 0 to 1. Score = 0 means no intention to receive the PSA test while score = 1 means intention to receive the PSA test. Preference-concordant decision making will be scored as 1 (POSITIVE) for those patients with Intention-to-Screen value = 1 who actually receive the PSA test during the study timeframe, or for those patients with Intention-to-Screen value = 0 who did not receive it. Preference-concordant decision making will be scored as 0 (NEGATIVE) for those patients with Intention-to-Screen value = 1 who did not receive the PSA test during the study timeframe, or for those patients with Intention-to-Screen value = 0 who did receive it. A congruence score of 1 means congruence between patient intention and real action, while a congruence score of 0 means patient in congruence between intention and real action.
Time frame: Through study completion, an average of 1 year
Population: Congruence was assessed only for patients who completed the follow-up (60 in the intervention group, and 53 in the control group).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intervention | Preference-Congruent Decision Making | Participants with Congruence Score = 1 | 36 Number of participants |
| Intervention | Preference-Congruent Decision Making | Participants with Congruence Score = 0 | 24 Number of participants |
| Usual Care | Preference-Congruent Decision Making | Participants with Congruence Score = 1 | 40 Number of participants |
| Usual Care | Preference-Congruent Decision Making | Participants with Congruence Score = 0 | 13 Number of participants |
Comparison: H0: piI = piCp-value: 0.121695% CI: [-0.342, 0.033]t-test, 2 sided
Secondary
Quality of Decision (QD)
The total QD score ranges from 0 to 100. Higher percentage scores mean higher quality of the decision made.
Time frame: Up to 24 weeks after the audio-recorded visit
Population: The QD was assessed only for patients who completed the follow-up (60 in the intervention group, and 53 in the control group).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Quality of Decision (QD) | 82.23 units on a scale | Standard Deviation 13.503 |
| Usual Care | Quality of Decision (QD) | 80.45 units on a scale | Standard Deviation 13.925 |
Comparison: H0:muI = muCp-value: 0.492995% CI: [-3.35, 6.91]t-test, 2 sided
Other Pre-specified
Acceptability
Participants complete a structured questionnaire to rate the acceptability of the enrollment process, study procedures, and their overall satisfaction with the study. The score ranges from 10 to 50. Higher scores mean higher acceptability of study procedures.
Time frame: Through study completion, an average of 1 year
Population: Acceptability was assessed only for patients who completed the follow-up (60 in the intervention group, and 53 in the control group).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Acceptability | 42.43 unit on a scale | Standard Deviation 5.318 |
| Usual Care | Acceptability | 43.17 unit on a scale | Standard Deviation 4.59 |
Comparison: H0:muI = muCp-value: 0.431295% CI: [-2.58, 1.11]t-test, 2 sided