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

A Pilot Cluster Randomized Controlled Trial of "Just ASK™", an Intervention to Increase Discussions About Breast Cancer Clinical Trials

The goal of this study is to conduct a pilot stepped-wedge cluster randomized controlled trial (RCT) of the "Just ASK™" training and implementation to increase provider discussions 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 CCT discussion rates pre- and post-intervention?
• What are discussion elements associated with breast cancer trial participation?

The study will be a stepped-wedge cluster RCT in which four participating practices (5-10 clinic members per each cluster) will receive the Just ASK training at different, randomly assigned time points. Clinic team participants will complete the training and develop an implementation strategy of Just ASK at the cluster level. Within each cluster, we will audio-record 10 patient-provider encounters pre-training and 10 encounters post-training to assess discussions of cancer clinical trials with breast cancer patients.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Behavioral: Just ASK training

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carmen Guerra, MD, MSCE; Phone Number: 215-349-5374; Email: carmen.guerra@pennmedicine.upenn.edu
• Study Contact Backup: Name: Sejin Lee, PhD; Email: sejin.lee@pennmedicine.upenn.edu

Study Locations

• United States
  • New Jersey
    • Plainsboro, New Jersey, United States, 08536
      • Recruiting
      • Princeton Medical Center
      • Contact: Ramy Sedhom, MD; Phone Number: 800-789-7366; Email: Ramy.Sedhom@pennmedicine.upenn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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
• Diagnosed with breast cancer and identified as potentially eligible for at least one breast cancer treatment clinical trial.
• Evaluated at the Abramson Cancer Center by those oncology team members participating in this study.
• Able to provide informed consent.

Exclusion criteria II (for patient participants):

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Just ASK training intervention; All clinic participants (4 clusters of breast cancer providers and team members) 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 discuss about cancer clinical trials with all eligible patients. The study design is a stepped-wedge RCT. Each cluster will begin in the pre-intervention (control) period and cross over to intervention (training) according to a randomized sequence.	Behavioral: 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 program aims to increase clinical trial discussions with all eligible cancer patients.
No Intervention: Control (Pre-intervention); All four participating clusters begin in the pre-intervention (control) stage and transition to the Just Ask training intervention at different, randomly assigned time points. Each cluster serves as its own comparison before and after the training intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rates of discussion of breast cancer clinical trials	Will measure differences in rates of discussion of clinical trials with breast cancer patients pre- and post-intervention (Just ASK training).	At the study completion (after all patient visit recordings are collected), an estimated average of 1 year after completion of recruitment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Factors associated with breast cancer clinical trial participation (The outcome measure is qualitative in nature and does not involve quantitative variables. This will be a non-numeric outcome based on qualitative analysis of patient-provider encounters)	We will explore patient- and provider-level factors associated with breast cancer clinical trial participation. This will involve a qualitative analysis of audio-recorded patient visits from both study arms to identify recurring themes and contextual elements related to trial discussions. For example, factors such as geographic distance from the clinic or presence/absence of caregivers may influence a patient's decision to participate in clinical trials. However, we do not have a pre-defined set of measures for this qualitative study aim as the goal is to identify emergent themes through qualitative analysis.	Up to 12 months after completion of data collection

Collaborators and Investigators

• Sponsor: Abramson Cancer Center at Penn Medicine
• Investigators: Principal Investigator: Carmen E Guerra, MD, University of Pennsylvania

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: June 4, 2025
• First Submitted That Met QC Criteria: June 26, 2025
• First Posted (Actual): June 27, 2025

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: 16126; BCRF-24-205 (Other Grant/Funding Number: Breast Cancer Research Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No