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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

• 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.

Locations
United States
New Jersey
Princeton Medical Center
RECRUITING
Plainsboro
Contact Information
Primary
Carmen Guerra, MD, MSCE
carmen.guerra@pennmedicine.upenn.edu
215-349-5374
Backup
Sejin Lee, PhD
sejin.lee@pennmedicine.upenn.edu
Time Frame
Start Date: 2026-02-01
Estimated Completion Date: 2026-10
Participants
Target number of participants: 80
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Leads: University of Pennsylvania

This content was sourced from clinicaltrials.gov