Prostate Cancer
Conditions
Keywords
African Americans, prostate cancer, Minority, Racial /Ethnic disparity, Cancer care, patient-physician communication, cancer clinical trial accrual
Brief summary
This research has the overall goal of increasing rates at which African American and White men with prostate cancer make an informed decision to participate in a cancer clinical trial.
Detailed description
This research utilizes two distinct research designs to evaluate two separate behavioral interventions. The first is a between-subject randomized controlled trial to evaluate a patient-focused intervention. The intervention consists of a booklet designed to encourage patients to view themselves as part of the patient-physician team and to participate actively in clinical interactions by asking questions and stating concerns. The second is a within-subject interrupted time series design to evaluate a physician-focused intervention. The intervention is an educational module and email reminders designed to encourage physicians to discuss trials with all eligible patients using patient-centered communication.In the patient-focused intervention, patients are randomized to an intervention or usual care group, and comparison of outcomes is made between groups.
Interventions
BEHAVIORALPatients: Questions to Ask Your Doctor: A Workbook for Patient-Doctor Teams
This booklet encourages patients to view themselves as members of the patient-doctor team and to participate actively during clinical interactions by asking questions and stating concerns.
BEHAVIORALPhysicians: Educational Module
Physicians will participate in an educational module and receive email prompts to encourage them to discuss trials with all patients who are eligible for a clinical trial, using patient-centered communication
Sponsors
National Cancer Institute (NCI)
Susan Eggly
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
Physician participants Inclusion criteria: * Treat patients with prostate cancer * Able to recruit patients to clinical trials
Exclusion criteria
* Do not treat patients with prostate cancer * Not able to recruit patients to clinical trials Patient Participants Inclusion criteria: * Black, African American or White; Non-hispanic confirmed diagnosis of prostate Cancer * Seeing a participating physician for less than a year and expect to see this physician at least once in the coming year * Able to read and write English well enough to understand and sign consent forms and respond to questionnaires
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physician Offers of a Clinical Trial | Day of clinical interaction; up to 2 years following enrollment | Single item: Did the physician offer a trial? |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Active Participation | Day of clinical interaction; up to 2 years following enrollment | Observers' global assessment of patients' participation in the interaction |
| Quality of Informed Consent (Modified) | 1 week following clinical interaction | 12-item patient-self report on Quality of Informed Consent (QUIC) |
| Patient Enrollment in Trial | 3 months following clinical interaction | medical chart abstraction |
| Patient Decisions to Enroll in a Trial | 1 week following clinical interaction | Single item: Did you agree to participate in this trial? |
| Quality of Trial-Related Communication | Day of clinical interaction; up to 2 years following enrollment | Observers' assessment of physician communication related to clinical trials |
| Physician Patient-Centeredness | Immediately following clinical interaction | 14-item patient self-report scale |
| Physician Patient-Centered Communication | Day of clinical interaction; up to 2 years following enrollment | Observers' rating of physician communication |
Countries
United States
Participant flow
Pre-assignment details
A total of 289 patients consented and completed baseline requirement. Of these, 54 qualified for randomization.
Participants by arm
| Arm | Count |
|---|---|
| Patients--Intervention Patients are randomized to an intervention group. They participate in all aspects of the study and also receive the intervention, which consists of a booklet.
Patients: Questions to Ask Your Doctor: A Workbook for Patient-Doctor Teams: This booklet encourages patients to view themselves as members of the patient-doctor team and to participate actively during clinical interactions by asking questions and stating concerns. | 25 |
| Patients--Usual Care Patients are randomized to the standard of care arm and participate in all aspects of the study but receive no intervention. | 29 |
| Physicians Physicians receive the intervention approximately halfway through data collection for a within subjects, pre-post intervention comparison
Physicians: Educational Module: Physicians will participate in an educational module and receive email prompts to encourage them to discuss trials with all patients who are eligible for a clinical trial, using patient-centered communication | 27 |
| Total | 81 |
Baseline characteristics
| Characteristic | Patients--Intervention | Patients--Usual Care | Physicians | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 14 Participants | 17 Participants | 2 Participants | 33 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants | 12 Participants | 25 Participants | 48 Participants |
| Age, Continuous Patients | 66.2 years STANDARD_DEVIATION 8.9 | 66.52 years STANDARD_DEVIATION 7.6 | 0 years STANDARD_DEVIATION 0 | 66.36 years STANDARD_DEVIATION 8.15 |
| Age, Continuous Physicians | 0 years STANDARD_DEVIATION 0 | 0 years STANDARD_DEVIATION 0 | 47.58 years STANDARD_DEVIATION 11.61 | 47.58 years STANDARD_DEVIATION 11.61 |
| Race/Ethnicity, Customized Black/African American | 13 Participants | 10 Participants | 2 Participants | 25 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 0 Participants | 6 Participants | 6 Participants |
| Race/Ethnicity, Customized White | 12 Participants | 17 Participants | 19 Participants | 48 Participants |
| Region of Enrollment United States | 25 participants | 29 participants | 27 participants | 81 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 4 Participants | 4 Participants |
| Sex: Female, Male Male | 25 Participants | 29 Participants | 23 Participants | 77 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 29 | 0 / 27 |
| other Total, other adverse events | 0 / 25 | 0 / 29 | 0 / 27 |
| serious Total, serious adverse events | 0 / 25 | 0 / 29 | 0 / 27 |
Outcome results
Primary
Physician Offers of a Clinical Trial
Single item: Did the physician offer a trial?
Time frame: Day of clinical interaction; up to 2 years following enrollment
Population: Data were collected only from participants in the Intervention Group in Phase 1 for this outcome measure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention and Offer | Physician Offers of a Clinical Trial | 14 Participants |
Secondary
Patient Active Participation
Observers' global assessment of patients' participation in the interaction
Time frame: Day of clinical interaction; up to 2 years following enrollment
Secondary
Patient Decisions to Enroll in a Trial
Single item: Did you agree to participate in this trial?
Time frame: 1 week following clinical interaction
Secondary
Patient Enrollment in Trial
medical chart abstraction
Time frame: 3 months following clinical interaction
Secondary
Physician Patient-Centered Communication
Observers' rating of physician communication
Time frame: Day of clinical interaction; up to 2 years following enrollment
Secondary
Physician Patient-Centeredness
14-item patient self-report scale
Time frame: Immediately following clinical interaction
Secondary
Quality of Informed Consent (Modified)
12-item patient-self report on Quality of Informed Consent (QUIC)
Time frame: 1 week following clinical interaction
Secondary
Quality of Trial-Related Communication
Observers' assessment of physician communication related to clinical trials
Time frame: Day of clinical interaction; up to 2 years following enrollment