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

NCT ID: NCT07040891

Last Updated: 2025-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2026-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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Just ASK training arm

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 Type EXPERIMENTAL

Just ASK training

Intervention Type BEHAVIORAL

"Just ASK™" is a web-based training designed to help providers understand the impact of assumptions about their patients' interest in cancer clinical trials. The training framework aims to increase clinical trial discussions with all cancer patients.

Usual care arm

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Just ASK training

"Just ASK™" is a web-based training designed to help providers understand the impact of assumptions about their patients' interest in cancer clinical trials. The training framework aims to increase clinical trial discussions with all cancer patients.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.


* 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

\- Previously completed "Just ASK™" training


\- Already consented to participate in a breast cancer clinical trial for their treatment
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Carmen E. Guerra

Ruth C. and Raymond G. Perelman Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Carmen E Guerra, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Central Contacts

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Carmen Guerra, MD, MSCE

Role: CONTACT

215-349-5374

Sejin Lee, PhD

Role: CONTACT

References

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Castillo BS, Boehmer L, Schrag J, Howson A, Oyer R, Pierce L, Barrett NJ, Guerra CE. Oncologist-Reported Barriers and Facilitators to Offering Cancer Clinical Trials to Their Patients. Curr Oncol. 2024 May 28;31(6):3017-3029. doi: 10.3390/curroncol31060230.

Reference Type BACKGROUND
PMID: 38920714 (View on PubMed)

Barrett NJ, Boehmer L, Schrag J, Benson AB 3rd, Green S, Hamroun-Yazid L, Howson A, Matin K, Oyer RA, Pierce L, Jeames SE, Winkfield K, Yang ES, Zwicker V, Bruinooge S, Hurley P, Williams JH, Guerra CE. 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. JCO Oncol Pract. 2023 Apr;19(4):e570-e580. doi: 10.1200/OP.22.00378. Epub 2023 Jan 11.

Reference Type BACKGROUND
PMID: 36630671 (View on PubMed)

Other Identifiers

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BCRF-24-205

Identifier Type: -

Identifier Source: org_study_id

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