PACCT: Partnering Around Cancer Clinical Trials

Study Overview
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Brief Summary
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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
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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.

Official Title
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PACCT: Partnering Around Cancer Clinical Trials

Conditions
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Prostate Cancer

Intervention / Treatment
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* Behavioral: Patients: Questions to Ask Your Doctor: A Workbook for Patient-Doctor Teams
* Behavioral: Physicians: Educational Module


Participation Criteria
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Eligibility Criteria
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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 Exclusion criteria: Not black, African American or White; non Hispanic No confirmed diagnosis of prostate cancer Not seeing a participating physician or seeing a participating physician for > than one year Not able to read and write English well enough to understand and sign consent forms and respond to questionnaires

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients--Intervention<br>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. | Behavioral: Patients: Questions to Ask Your Doctor: A Workbook for Patient-Doctor Teams<br>* 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.<br>|
| No Intervention: Patients--Usual Care<br>Patients are randomized to the standard of care arm and participate in all aspects of the study but receive no intervention. | |
| Other: Physicians<br>Physicians receive the intervention approximately halfway through data collection for a within subjects, pre-post intervention comparison | Behavioral: Physicians: Educational Module<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician Offers of a Clinical Trial | Single item: Did the physician offer a trial? | Day of clinical interaction; up to 2 years following enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Decisions to Enroll in a Trial | Single item: Did you agree to participate in this trial? | 1 week following clinical interaction | 
| Patient Active Participation | Observers' global assessment of patients' participation in the interaction | Day of clinical interaction; up to 2 years following enrollment | 
| Quality of Informed Consent (Modified) | 12-item patient-self report on Quality of Informed Consent (QUIC) | 1 week following clinical interaction | 
| Patient Enrollment in Trial | medical chart abstraction | 3 months following clinical interaction | 
| Physician Patient-Centered Communication | Observers' rating of physician communication | Day of clinical interaction; up to 2 years following enrollment | 
| Quality of Trial-Related Communication | Observers' assessment of physician communication related to clinical trials | Day of clinical interaction; up to 2 years following enrollment | 
| Physician Patient-Centeredness | 14-item patient self-report scale | Immediately following clinical interaction | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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African Americans, prostate cancer, Minority, Racial /Ethnic disparity, Cancer care, patient-physician communication, cancer clinical trial accrual