PACCT: Partnering Around Cancer Clinical Trials

Susan Eggly316 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

316

Conditions

Prostate Cancer

Interventions

Patients: Questions to Ask Your Doctor: A Workbook for Patient-Doctor TeamsBEHAVIORAL

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.

Physicians: Educational ModuleBEHAVIORAL

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

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Johns Hopkins University/Sidney Kimmel Comprehensive Cancer

Baltimore, Maryland, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

Patient Decisions to Enroll in a Trial

Single item: Did you agree to participate in this trial?

Time frame: 1 week following clinical interaction

Patient Active Participation

Observers' global assessment of patients' participation in the interaction

Time frame: 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)

Time frame: 1 week following clinical interaction

Patient Enrollment in Trial

medical chart abstraction

Time frame: 3 months following clinical interaction

Physician Patient-Centered Communication

Observers' rating of physician communication

Time frame: Day of clinical interaction; up to 2 years following enrollment

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

Physician Patient-Centeredness

14-item patient self-report scale

Data from ClinicalTrials.gov

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