PACCT: Partnering Around Cancer Clinical Trials

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Behavioral: Patients: Questions to Ask Your Doctor: A Workbook for Patient-Doctor Teams; Behavioral: Physicians: Educational Module

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 Type: Interventional
• Enrollment (Actual): 316
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University/Sidney Kimmel Comprehensive Cancer
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Karmanos Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
No Intervention: Patients--Usual Care; Patients are randomized to the standard of care arm and participate in all aspects of the study but receive no intervention.
Other: Physicians; Physicians receive the intervention approximately halfway through data collection for a within subjects, pre-post intervention comparison	Behavioral: 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Susan Eggly
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Susan Eggly, Ph.D., Wayne State University

Publications and helpful links

General Publications

• Eggly S, Hamel LM, Heath E, Manning MA, Albrecht TL, Barton E, Wojda M, Foster T, Carducci M, Lansey D, Wang T, Abdallah R, Abrahamian N, Kim S, Senft N, Penner LA. Partnering around cancer clinical trials (PACCT): study protocol for a randomized trial of a patient and physician communication intervention to increase minority accrual to prostate cancer clinical trials. BMC Cancer. 2017 Dec 2;17(1):807. doi: 10.1186/s12885-017-3804-5.

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2016
• Primary Completion (Actual): July 17, 2021
• Study Completion (Actual): July 17, 2021

Study Registration Dates

• First Submitted: September 8, 2016
• First Submitted That Met QC Criteria: September 19, 2016
• First Posted (Estimate): September 20, 2016

Study Record Updates

• Last Update Posted (Estimate): January 16, 2023
• Last Update Submitted That Met QC Criteria: December 20, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: prostate cancer; African Americans; Minority; Racial /Ethnic disparity; Cancer care; patient-physician communication; cancer clinical trial accrual
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 2016-098; R01CA200718-01 (U.S. NIH Grant/Contract)