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NCT Number: NCT07040891

A Pilot Trial of "Just ASK™" 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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Princeton Medical Center

Plainsboro, New Jersey, 08536, United States

Location status: Recruiting

Location contact

Ramy Sedhom, MD

CONTACT

[email protected]

800-789-7366

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Just ASK training

Behavioral

"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 outcomes

  1. 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.

    Will measure differences in rates of discussion of clinical trials with breast cancer patients pre- and post-intervention (Just ASK training).

Secondary outcomes

  1. Factors associated with breast cancer clinical trial participation (The outcome measure is qualitative in nature and does not involve quantitative variables. This will be a non-numeric outcome based on qualitative analysis of patient-provider encounters)

    Time frame: Up to 12 months after completion of data collection

    We will explore patient- and provider-level factors associated with breast cancer clinical trial participation. This will involve a qualitative analysis of audio-recorded patient visits from both study arms to identify recurring themes and contextual elements related to trial discussions. For example, factors such as geographic distance from the clinic or presence/absence of caregivers may influence a patient's decision to participate in clinical trials. However, we do not have a pre-defined set of measures for this qualitative study aim as the goal is to identify emergent themes through qualitative analysis.

Study contacts

Contact information is provided by the study sponsor or research team.

Carmen Guerra, MD, MSCE

CONTACT

[email protected]

215-349-5374

Sejin Lee, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 27, 2025
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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