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.

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