Breast Cancer
Conditions
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.
Interventions
BEHAVIORALJust 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.
Sponsors
Abramson Cancer Center at Penn Medicine
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rates of discussion of breast cancer clinical trials | 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
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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. |
Countries
United States
Contacts
CONTACTCarmen Guerra, MD, MSCE
CONTACTSejin Lee, PhD
PRINCIPAL_INVESTIGATORCarmen E Guerra, MD
University of Pennsylvania
Outcome results
None listed