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

Официальное название

A Pilot Cluster Randomized Controlled Trial of "Just ASK™", an Intervention to Increase Discussions About Breast Cancer Clinical Trials

Обзор

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.

Вмешательства

• Поведенческое Just 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.

Первичные конечные точки

• Rates of discussion of breast cancer clinical trials [Срок оценки: At the study completion (after all patient visit recordings are collected), an estimated average of 1 year after completion of recruitment.]

Вторичные конечные точки (1)

• 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) [Срок оценки: Up to 12 months after completion of data collection]

Критерии участия

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

США · 1 центр

• Princeton Medical Center — Plainsboro

Публикации

• 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. PMID 38920714
• 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-e5 PMID 36630671

Идентификаторы

NCT: NCT07040891 · 16126 · BCRF-24-205

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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