PACCT: Partnering Around Cancer Clinical Trials

Susan Eggly

Status: Completed

Conditions: Prostate Cancer

Treatments: Behavioral: Physicians: Educational Module; Behavioral: Patients: Questions to Ask Your Doctor: A Workbook for Patient-Doctor Teams

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02906241

2016-098

R01CA200718-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 316 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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316 participants in 3 patient groups

Patients--Intervention

Experimental group

Description:

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.

Treatment:

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

Patients--Usual Care

No Intervention group

Description:

Patients are randomized to the standard of care arm and participate in all aspects of the study but receive no intervention.

Physicians

Other group

Description:

Physicians receive the intervention approximately halfway through data collection for a within subjects, pre-post intervention comparison

Treatment:

Behavioral: Physicians: Educational Module