Recruiting

Just ASK™

Sponsor:

Abramson Cancer Center at Penn Medicine

Code:

NCT07040891

Conditions

Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Just ASK training

Study Details

Brief 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.

Conditions

Breast Cancer

Study ID

NCT07040891

Start date

Feb 1, 2026

Status verified date

Apr, 2026

Completion date

Oct, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

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.

Interventions

Just ASK training

"Just ASK™" is a web-based training designed to help providers understand the impact of assumptions about their patients' interest in cancer clinical trials. The training program aims to increase clinical trial discussions with all eligible cancer patients.

Primary outcome measure

  • Rates of discussion of breast cancer clinical trials [ Time Frame: At the study completion (after all patient visit recordings are collected), an estimated average of 1 year after completion of recruitment. ]

Central Contacts and Locations

Central contacts

Carmen Guerra, MD, MSCE

215-349-5374carmen.guerra@pennmedicine.upenn.edu

Sejin Lee, PhD

sejin.lee@pennmedicine.upenn.edu

Locations

Princeton Medical Center

Recruiting

Plainsboro, New Jersey, United States, 08536

Contacts

Ramy Sedhom, MD

800-789-7366Ramy.Sedhom@pennmedicine.upenn.edu

More Information

Sponsor

Abramson Cancer Center at Penn Medicine

Last update posted

Apr 23, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Abramson Cancer Center at Penn Medicine on 2026-04-23.