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

Not Applicable

Not yet recruiting

• Conditions: Breast Cancer

• Registration Number: NCT07040891
• Lead Sponsor: University of Pennsylvania

Brief Summary

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

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-04
• Study First Submitted QC: 2025-06-26
• Last Update Submitted: 2025-06-26
• Study First Posted: 2025-06-27
• Last Update Posted: 2025-06-27
• Study Start: 2025-10-01
• Primary Completion: 2026-10
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Rates of discussion of breast cancer clinical trials	At the study completion (after all patient visit recordings are collected), an estimated average of 1 year after completion of recruitment.	Will measure differences in rates of discussion of clinical trials with breast cancer patients between intervention and control arms

Secondary Outcome Measures

Name	Time	Method
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	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.

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States