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

NCT07040891 | Recruiting

• 2 other identifiers: 16126BCRF-24-205
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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)

  Up to 12 months after completion of data collection

Study Arms (2)

Just ASK training intervention

EXPERIMENTAL

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

Control (Pre-intervention)

NO 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.

Interventions

Just ASK training 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 program aims to increase clinical trial discussions with all eligible cancer patients.

Just ASK training intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- Previously completed "Just ASK™" training
• 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.
• \- Already consented to participate in a breast cancer clinical trial for their treatment

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Princeton Medical Center

Plainsboro, New Jersey, 08536, United States

RECRUITING

Related Publications (2)

• 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.

  PMID: 38920714 BACKGROUND

• 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.

  PMID: 36630671 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Carmen E Guerra, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carmen Guerra, MD, MSCE

CONTACT

215-349-5374; carmen.guerra@pennmedicine.upenn.edu

Sejin Lee, PhD

CONTACT

sejin.lee@pennmedicine.upenn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ruth C. and Raymond G. Perelman Professor of Medicine

Model Details: This is a stepped-wedge cluster RCT of Just ASK training program. All clusters (5-10 providers per cluster) begin in the pre-intervention (pre-training) stage and will sequentially cross over to the intervention according to a randomized rollout schedule.

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: June 27, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)