UPCC 16126 A Hybrid Type 1 EffectivenessImplementation Pilot Stepped-Wedge Cluster Randomized Controlled Trial of the Just ASK Training and Implementation to Increase Discussion of Breast Cancer Treatment Trials, with a Nested Qualitative Analysis of Breast Cancer Clinical Trial Discussion Elements Associated with Trial Participation
Investigating the Impact of Just ASK Training on Breast Cancer Trial Discussions
Brief description of study
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.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Breast Cancer
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Age: 18 years or above
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Gender: All
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
This study investigates the effectiveness of the "Just ASK" training program in enhancing discussions about breast cancer clinical trials between healthcare providers and patients. The purpose of this study is to evaluate if the training can increase the frequency and quality of these discussions, which are crucial for patient enrollment in clinical trials. The study will involve oncology teams who routinely work with breast cancer patients.
Participants in the study will include oncology team members who will undergo the Just ASK training. The study will compare the number of clinical trial discussions before and after the training by audio-recording patient-provider encounters. This will help assess the impact of the training on clinical trial discussions.
- Who can participate: Oncology team members at the Abramson Cancer Center who have not completed the 'Just ASK' training and patients over 18 diagnosed with breast cancer, identified as potentially eligible for a breast cancer treatment clinical trial, are eligible.
- Study details: Oncology team members will participate in the Just ASK training and develop strategies to implement it in their practice. Their interactions with patients will be recorded to evaluate changes in clinical trial discussions.
Study is selecting its participants from a population, or group of people, decided on by the researchers in advance.
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