Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Just ASK training | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Just ASK training intervention
- description
- 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.
- interventionNames
- Behavioral: Just ASK training
- type
- NO_INTERVENTION
- label
- Control (Pre-intervention)
- description
- 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.
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDCastillo 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
- BACKGROUNDBarrett 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