Just ASK™ training to increase provider conversations about breast cancer clinical trials
A Pilot Cluster Randomized Controlled Trial of "Just ASK™", an Intervention to Increase Discussions About Breast Cancer Clinical Trials
This pilot tests whether Just ASK™ training helps oncology clinic teams at Abramson Cancer Center have more conversations with eligible breast cancer patients about joining clinical trials.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Abramson Cancer Center at Penn Medicine Academic / other |
| Locations | 1 site (Plainsboro, New Jersey) |
| Trial ID | NCT07040891 on ClinicalTrials.gov |
What this trial studies
The study is a pilot stepped-wedge cluster randomized trial in which four clinic teams (each 5–10 members) receive Just ASK™ training at different, randomly assigned times. Oncology team members who routinely offer and enroll patients in breast cancer trials will complete the training and implementation activities, while rates and elements of trial discussions with eligible patients will be measured before and after training. The trial aims to assess feasibility and acceptability, identify determinants of who completes and uses the training, and link discussion elements to subsequent trial participation. Results will inform the design of a larger definitive cluster randomized trial.
Who should consider this trial
Good fit: Adults over 18 with breast cancer who are seen by participating Abramson Cancer Center oncology teams and are considered potentially eligible for at least one treatment clinical trial are ideal candidates.
Not a fit: Patients who are already consented to a breast cancer treatment clinical trial or who are not seen at the participating clinics would not directly benefit from this intervention.
Why it matters
Potential benefit: If successful, the intervention could increase how often eligible breast cancer patients are offered and enroll in clinical trials, improving patient access to experimental treatments.
How similar studies have performed: Prior clinician-training and implementation interventions have shown mixed but sometimes positive effects on increasing trial conversations and enrollment, so this pilot tests feasibility in this specific setting.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Plainsboro, New Jersey
- Princeton Medical Center — Plainsboro, New Jersey, United States (Recruiting)
Study contacts
- Principal investigator: Carmen E Guerra, MD — University of Pennsylvania
- Study coordinator: Carmen Guerra, MD, MSCE
- Email: carmen.guerra@pennmedicine.upenn.edu
- Phone: 215-349-5374
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.