PACCT: Partnering Around Cancer Clinical Trials

Not Applicable

Completed

• Conditions: Prostate Cancer

• Registration Number: NCT02906241
• Lead Sponsor: Susan Eggly

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.

Study Timeline

• Study First Submitted: 2016-09-08
• Study First Submitted QC: 2016-09-19
• Study Start: 2016-09-20
• Study First Posted: 2016-09-20
• Primary Completion: 2021-07-17
• Study Completion: 2021-07-17
• Results First Submitted: 2022-08-22
• Status Verified: 2022-12
• Results First Submitted QC: 2022-12-20
• Last Update Submitted: 2022-12-20
• Results First Posted: 2023-01-17
• Last Update Posted: 2023-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 316

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Patient Active Participation	Day of clinical interaction; up to 2 years following enrollment	Observers' global assessment of patients' participation in the interaction
Patient Decisions to Enroll in a Trial	1 week following clinical interaction	Single item: Did you agree to participate in this trial?
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
Physician Patient-Centered Communication	Day of clinical interaction; up to 2 years following enrollment	Observers' rating of physician communication
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

Trial Locations

Locations (2)

Johns Hopkins University/Sidney Kimmel Comprehensive Cancer; 🇺🇸 Baltimore, Maryland, United States

Karmanos Cancer Institute; 🇺🇸 Detroit, Michigan, United States