A Pilot Cluster Randomized Controlled Trial of "Just ASK™", an Intervention to Increase Discussions About Breast Cancer Clinical Trials
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Rates of discussion of breast cancer clinical trials
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Health Services Research
- 盲法
- None (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •I (for oncology team members):
- •- Previously completed "Just ASK™" training
- •Inclusion criteria II (for patient participants):
- •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
研究组 & 干预措施
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.
干预措施: Just ASK training (Behavioral)
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.
结局指标
主要结局
Rates of discussion of breast cancer clinical trials
时间窗: 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).
次要结局
- 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)
研究者
Carmen E. Guerra
Ruth C. and Raymond G. Perelman Professor of Medicine
University of Pennsylvania