Just ASK Training for Breast Cancer

Overseen By Sejin Lee, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Completed Just ASK training, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 40

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to increase the frequency of discussions between doctors and breast cancer patients about joining clinical trials. The study compares clinics using a special training program called Just ASK™ with those not receiving the training. It focuses on identifying discussion methods that encourage more patients to consider joining clinical trials. Patients who are newly diagnosed or have relapsed breast cancer and are seen at the Abramson Cancer Center might be suitable for this trial. As an unphased study, this trial offers patients the opportunity to contribute to research that could improve communication and support for future breast cancer patients.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that the Just ASK training is safe for providers and patients?

Research shows that the Just ASK™ training program helps healthcare providers communicate more effectively with patients about cancer clinical trials. The program is online and interactive, providing a safe and easy learning method for providers.

Studies have found that Just ASK™ reduces hidden biases among healthcare workers, leading to improved conversations about clinical trials with patients. No negative effects have been identified from this training, as it focuses on learning and communication skills. Therefore, participating in the Just ASK™ training is safe and poses no health risks to participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Just ASK™ training because it addresses a gap in how healthcare providers discuss clinical trials with breast cancer patients. Unlike usual care, which might overlook potential trial opportunities, this web-based training helps providers systematically and inclusively ask all patients about their interest in clinical trials. By reducing assumptions and encouraging open conversations, Just ASK™ has the potential to increase patient participation in trials and ensure equitable access to cutting-edge treatments.

What evidence suggests that the Just ASK™ training is effective for increasing clinical trial discussions in breast cancer patients?

Research has shown that the Just ASK™ training program, available to participants in this trial, helps healthcare providers engage more with breast cancer patients about clinical trials. The program enables doctors to overcome biases that might prevent them from discussing trial opportunities with all patients. Studies indicate that Just ASK™ removes barriers to joining clinical trials, particularly by increasing participant diversity. By encouraging providers to ask every patient about trial participation, the training aims to give everyone a fair chance to join. Early results suggest that when providers use the Just ASK™ method, more patients learn about and consider joining clinical trials. ^{1 3 6 7 8}

Who Is on the Research Team?

Carmen E Guerra, MD

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

This trial is for breast cancer clinics and their staff, aiming to see if training can help them talk more about clinical trials with patients. Clinics are randomly chosen to either get the 'Just ASK' training or not. Staff in the trained clinics will learn how to discuss clinical trials better.

Inclusion Criteria

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

Are evaluated at the Abramson Cancer Center by those oncology team members participating in this study

Exclusion Criteria

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

Previously completed 'Just ASK™' training

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants in the intervention arm complete 'Just ASK™' training and develop an implementation plan

12 months

Up to 20 patient encounters per practice recorded

Control

Participants in the control arm receive usual care without the training intervention

12 months

Up to 20 patient encounters per practice recorded

Follow-up

Participants are monitored for differences in clinical trial discussions and factors associated with trial participation

Up to 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Just ASK™

Trial Overview 'Just ASK™' training is being tested to see if it increases discussions between healthcare providers and breast cancer patients about participating in clinical trials. The study compares clinics that receive this special training against those that do not.

How Is the Trial Designed?

Group I: Just ASK training arm Experimental Treatment 1 Intervention

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.

Group II: Usual care arm Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07040891

A Pilot Trial of "Just ASK™" to Increase Discussions 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 ...

2. ascopubs.org ascopubs.org/doi/10.1200/OP.22.00785

Toward Achieving Equity in Cancer Clinical Trials An assessment of the feasibility and utility of an ACCC-ASCO implicit bias training program to enhance racial and ethnic diversity in cancer clinical trials.

3. accc-cancer.org accc-cancer.org/docs/documents/oncology-issues/articles/2023/v38-n2/how-one-healthcare-system-is-operationalizing-this-implicit-bias-program-to-ensure-equitable-access-to-clinical-trials.pdf?sfvrsn=fe0b9ba3_10&

Just ASK! The Just ASK™ Training Program addresses the recognized barrier to clinical trial enrollment highlighted in the recent study by Unger and ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11811461/

Therapeutic Clinical Trial Eligibility and Enrollment among ... This study explored associations between breast cancer patient demographics, clinical trial eligibility, and enrollment in a National Cancer Institute (NCI)- ...

5. breastcancer.org breastcancer.org/podcast/just-ask-diversity-clinical-trials

Just Ask: Increasing Diversity in Clinical Trials Dr. Nadine Barrett discusses why diversity in clinical trials is so important and how the Just Ask program helps address that lack of diversity.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39561316/

Longitudinal Results From the Nationwide Just ASK Initiative ... Just ASK is the latest, and by far the largest, endeavor to improve assessment of cancer patients' smoking status. Participants reported significant ...

7. ascopubs.org ascopubs.org/doi/abs/10.1200/JCO.24.00304

Longitudinal Results From the Nationwide Just ASK ... Just ASK is the latest, and by far the largest, endeavor to improve assessment of cancer patients' smoking status.

8. facs.org facs.org/for-medical-professionals/news-publications/news-and-articles/cancer-programs-news/120524/authors-review-just-ask-results-in-jco/

Authors Review Just ASK Results in JCO | ACS Just ASK is the latest, and by far the largest, endeavor to improve assessment of cancer patients' smoking status.