跳至主要内容
临床试验/NCT05400941
NCT05400941Enrolling By Invitation不适用

Adapting and Implementing Evidence-based Breast Cancer Follow-up in Primary Care

Rutgers, The State University of New Jersey2 个研究点 分布在 1 个国家目标入组 910 人开始时间: 2024年6月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
910
试验地点
2
主要终点
Change in Comprehensive Breast Cancer Follow-up Care

研究概览

简要总结

This mixed methods study evaluates the effectiveness of an organizational intervention to enhance implementation of strategies to increase breast cancer survivorship symptom and risk management.

详细描述

Aim 3 is a hybrid type 1 effectiveness-implementation cluster randomized study with a waitlist control in 26 primary care practices. This study uses a tailored combination of practice facilitation, expert consultation, collaborative learning events, and audit and feedback as intervention strategies, and a mixed-methods comparative case study learning evaluation for primary care practices to adapt priority recommendations of evidence-based activities for breast cancer survivorship care. Intervention effectiveness will be assessed in two groups of clinics: 13 cases that will receive the implementation intervention and 13 waitlist controls. Impact of this implementation will be measured using mixed methods to assess Exploration, Preparation, Implementation and Sustainment factors related to how organizational and contextual variables affect adoption, implementation and early sustainability for provision of follow-up care, symptom, and risk management activities at 6 and 12 months post implementation. Aim 3 surveys 20 clinicians and staff members from 26 intervention practices (n=520) and conducts key informant interviews with 5 health care team members (who have participated in the survey; n=130) and 15 breast cancer survivors per practice (n=390; 5 per assessment point at baseline, 6 months and 12 months post intervention). Medical records of 20 patients with a history of breast cancer per practice per assessment point at baseline, 6 months and 12 months post intervention will be randomly selected for review (N=1,560) to assess and compare comprehensive breast cancer follow-up care outcomes. Sustainment will be measured through continued monitoring of the medical records for the 13 initial intervention practices at 18 and 24 months (N=520).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Self-identification as a staff member or patient who has had breast cancer in a participating practice

排除标准

  • Unable to speak, understand and/or read English
  • Unable to provide informed consent

研究组 & 干预措施

Practice Led Intervention

Active Comparator

Clinic staff will participate in learning collaborative and practice facilitation as well as receive expert consultation and audit and feedback.

干预措施: Practice Led Intervention (Behavioral)

Standard of Care

No Intervention

No intervention.

结局指标

主要结局

Change in Comprehensive Breast Cancer Follow-up Care

时间窗: Repeated measures at baseline, 6 months, 12 months, 18 months and 24 months

Percent of eligible recommendations performed per patient to assess the comprehensiveness of the follow up care received

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shawna V. Hudson, PhD

Professor

Rutgers, The State University of New Jersey

研究点 (2)

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