A Pilot Trial of "Just ASK™" to Increase Discussions About Breast Cancer Clinical Trials

University of Pennsylvania

Status: Begins enrollment in 2 months

Conditions: Breast Cancer

Treatments: Behavioral: Just ASK training

Study type: Interventional

Funder types: Other

Identifiers

NCT07040891

BCRF-24-205

Details and patient eligibility

About

The goal of this study is to conduct a pilot cluster randomized controlled trial (RCT) of the "Just ASK™" training and implementation to increase provider discussion of cancer clinical trials (CCTs) with patients with breast cancer. The main research questions the study aims to answer are:

• Is a cluster RCT feasibility and acceptable? (This will inform the design of a future definitive cluster RCT)
• What are the determinants of the Just Ask training completion and implementation in practice to develop a better understanding for whom the intervention works, and under what circumstances?
• What are the discussion elements and approaches that are associated with participation in breast cancer clinical trials?

Researchers will compare the intervention arm (breast cancer clinics assigned to the Just ASK training) with the control arm (clinics receiving no training) to evaluate differences in clinical trial discussions with eligible breast cancer patients. Clinic participants in the intervention arm will complete the training and develop an implementation plan of training framework. Across all participating practices, up to 20 patient encounters per practice will be recorded to identify discussion elements associated with clinical trial participation.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria I (for oncology team members):

• Members of teams of oncology (physicians, nurses/nurse practitioners and coordinators) who routinely offer, consent and enroll patients in breast cancer clinical trials at the Abramson Cancer Center, Philadelphia, PA
• Able to provide informed consent.

Exclusion criteria I (for oncology team members):

• Previously completed "Just ASK™" training

Inclusion criteria II (for patient participants):

• Age >18
• New or relapsed patients diagnosed with breast cancer
• Are evaluated at the Abramson Cancer Center by those oncology team members participating in this study
• Are able to provide informed consent.

Exclusion criteria II (for patient participants):

• Already consented to participate in a breast cancer clinical trial for their treatment

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Just ASK training arm

Experimental group

Description:

Participants in this arm will complete "Just ASK™" training, a web-based program designed to help providers understand the impact of assumptions about their patients' interest in cancer clinical trials and describe the "Just ASK™" framework for systematically asking all patients about cancer clinical trials.

Treatment:

Behavioral: Just ASK training

Usual care arm

No Intervention group

Description:

Participants in the usual care arm will not receive the training intervention.