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| ID | Type | Description | Link |
|---|---|---|---|
| BCRF-24-205 | Other Grant/Funding Number | Breast Cancer Research Foundation |
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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Just ASK training intervention | Experimental | 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. |
|
| Control (Pre-intervention) | No 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Rates of discussion of breast cancer clinical trials | Will measure differences in rates of discussion of clinical trials with breast cancer patients pre- and post-intervention (Just ASK training). | At the study completion (after all patient visit recordings are collected), an estimated average of 1 year after completion of recruitment. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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. |
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Inclusion criteria I (for oncology team members):
Exclusion criteria I (for oncology team members):
- Previously completed "Just ASK™" training
Inclusion criteria II (for patient participants):
Exclusion criteria II (for patient participants):
- Already consented to participate in a breast cancer clinical trial for their treatment
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carmen Guerra, MD, MSCE | Contact | 215-349-5374 | carmen.guerra@pennmedicine.upenn.edu | |
| Sejin Lee, PhD | Contact | sejin.lee@pennmedicine.upenn.edu |
| Name | Affiliation | Role |
|---|---|---|
| Carmen E Guerra, MD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Princeton Medical Center | Recruiting | Plainsboro | New Jersey | 08536 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38920714 | Background | Castillo 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. | |
| 36630671 | Background | Barrett 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. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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This is a stepped-wedge cluster RCT of Just ASK training program. All clusters (5-10 providers per cluster) begin in the pre-intervention (pre-training) stage and will sequentially cross over to the intervention according to a randomized rollout schedule.
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| Up to 12 months after completion of data collection |
| D017437 |
| Skin and Connective Tissue Diseases |