PACCT: Partnering Around Cancer Clinical Trials

NCT ID: NCT02906241

Last Updated: 2023-01-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 316 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-20
• Study Completion Date: 2021-07-17

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

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.

Patients--Usual Care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Physicians

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

Group Type: OTHER

Physicians: Educational Module

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: 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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Treat patients with prostate cancer
• Able to recruit patients to clinical trials

• 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

• Do not treat patients with prostate cancer
• Not able to recruit patients to clinical trials

Patient Participants

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Susan Eggly

OTHER

Sponsor Role: lead

Responsible Party

Susan Eggly

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Susan Eggly, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Wayne State University

Locations

Johns Hopkins University/Sidney Kimmel Comprehensive Cancer

Baltimore, Maryland, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

Countries

United States

References

Eggly S, Manning M, Senft N, Moore TF, Albrecht TL, Penner LA, Heath E, Carducci MA, Lansey DG, Hamel LM. Development and pilot test of a physician-focused cancer clinical trials communication training intervention. PEC Innov. 2021 Dec 16;1:100012. doi: 10.1016/j.pecinn.2021.100012. eCollection 2022 Dec.

Reference Type: DERIVED

PMID: 37364021 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29197371 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R01CA200718-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2016-098

Identifier Type: -

Identifier Source: org_study_id