PACCT: Partnering Around Cancer Clinical Trials

Sponsor

Susan Eggly (Other)

Overall Status

Completed

CT.gov ID

NCT02906241

Collaborator

National Cancer Institute (NCI) (NIH)

368

Enrollment

Locations

Arms

57.1

Actual Duration (Months)

184

Patients Per Site

3.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Behavioral: Patients: Questions to Ask Your Doctor: A Workbook for Patient-Doctor Teams Behavioral: Physicians: Educational Module	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

368 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

PACCT: Partnering Around Cancer Clinical Trials

Actual Study Start Date :

Sep 20, 2016

Actual Primary Completion Date :

Jun 23, 2021

Actual Study Completion Date :

Jun 23, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Patient decisions to enroll in a trial [1 week following clinical interaction]
Single item: Did you agree to participate in this trial?

Secondary Outcome Measures

Physician offers of a clinical trial [Day of clinical interaction; up to 2 years following enrollment]
Single item: Did the physician offer a trial?
Patient Active Participation [Day of clinical interaction; up to 2 years following enrollment]
Observers' global assessment of patients' participation in the interaction
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins University/Sidney Kimmel Comprehensive Cancer	Baltimore	Maryland	United States	21287
2	Karmanos Cancer Institute	Detroit	Michigan	United States	48201