A Pilot Trial of "Just ASK™" to Increase Discussions About Breast Cancer Clinical Trials

Part of paid clinical trials in Plainsboro, New Jersey.

Sponsor
Abramson Cancer Center at Penn Medicine
Study ID
NCT07040891
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Feb 1, 2026
Status verified
Apr 2026
Primary completion
Oct 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH

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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
Princeton Medical CenterPlainsboroNew Jersey08536
Ramy Sedhom, MD
[email protected]
800-789-7366

Find similar trials in Plainsboro, NJ

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Princeton Medical Center· Plainsboro, NJ

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