PACCT: Partnering Around Cancer Clinical Trials

Prostate Cancer Clinical Trial

Official title:

PACCT: Partnering Around Cancer Clinical Trials

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02906241
• Other study ID #: 2016-098
• Secondary ID: R01CA200718-01
• Status: Completed
• Phase: N/A
• Start date: September 20, 2016
• Est. completion date: July 17, 2021

Study information

• Verified date: December 2022
• Source: Barbara Ann Karmanos Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 316
• Est. completion date: July 17, 2021
• Est. primary completion date: July 17, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.
• 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

Locations

Country	Name	City	State
United States	Johns Hopkins University/Sidney Kimmel Comprehensive Cancer	Baltimore	Maryland
United States	Karmanos Cancer Institute	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Susan Eggly	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

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