Genetic Counseling Service Delivery and Outcomes in Diverse and Underserved Populations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 419
- 试验地点
- 1
- 主要终点
- Change in Knowledge Score
研究概览
简要总结
This 2-arm prospective, randomized, controlled clinical trial compared outcomes of telephone genetic counseling (intervention) versus in-person genetic counseling (control) in an underserved, multilingual patient population referred for cancer genetic counseling at two North Texas safety-net hospitals.
The main question[s] it aims to answer are:
- Is telephone genetic counseling equal to in-person genetic counseling in the patient reported outcomes? Cancer genetics knowledge, attitude towards GT, and informed choice as well as GC-specific empowerment.
- Is telephone genetic counseling-based clinical outcomes the same as in-person genetic counseling for visit completion and testing rates? Participants will be randomized to either in-person or telephone genetic counseling arm and complete standard of care genetic counseling visit process where testing is offered. Both arms will complete a series of surveys to assess the outcomes of interest.
详细描述
The overarching goal of this pilot prospective randomized controlled study is to compare patient-reported and clinical operations outcomes between in-person genetic counseling (IPGC - control) and telephone-based genetic counseling (TGC - intervention) in an indigent English or Spanish-speaking population seeking genetic counseling for hereditary cancer syndromes to create a framework for effective and efficient genetic service delivery in these populations nationally. General genetic education and principles will be conveyed through a standard genetic counseling session including a pre-test education video in both the TGC and IPGC arms. The primary project objectives are to compare the following outcomes between the IPGC and TGC study arms. Aim 1: Patient reported outcomes - A. Patient satisfaction with genetic counseling visit; B. Knowledge of basic principles of cancer genetics and implications of genetic testing for personal healthcare and relatives. Secondary objectives for this aim are: 1. Patient ability to make informed choice; and 2. Genetic counseling-specific empowerment outcomes. Aim 2: Clinical outcomes - visit completion rate; Secondary objectives are: 1. Genetic testing completion rate; and 2. Genetic testing cancelation/failure rate. Investigators hypothesize that patients in the TGC arm will not have significant differences in knowledge, satisfaction, informed choice or genetic counseling-specific empowerment compared to the IPGC arm. Investigators also expect significantly increased visit completion rate and lower test completion rate in the TGC arm compared to the IPGC arm, but no significant difference in sample failure rate.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Patients who are English or Spanish-speaking
- •Adults (18 years and older)
- •Patients scheduled for cancer genetic counseling
- •Patients must either be uninsured or have Medicaid
- •Patients must have no prior germline genetic testing or cancer genetic counseling
- •Patients must have a working telephone number and valid e-mail address
- •Patients must have Internet access to complete electronic study surveys, and receive study-related documents electronically
结局指标
主要结局
Change in Knowledge Score
时间窗: MMIC Survey administered within 7 days prior to and post-genetic counseling visit
Measure change in knowledge of basic principles of cancer genetics and implications of genetic testing for personal healthcare and relatives pre- and post- genetic counseling using the Multi-dimensional Model of Informed Choice (MMIC) scale knowledge score, with minimum and maximum scores of 0 and 8 respectively, and higher scores correlated with better knowledge
Patient Reported Outcome of Patient Satisfaction
时间窗: GCSS survey administered within 7 days post-genetic counseling visit
Measure patient-reported patient satisfaction with genetic counseling visit using the Genetic Counseling Satisfaction Scale (GCSS) scores, with minimum and maximum values of 6 and 30 respectively and higher scores correlated with higher satisfaction
Clinical Outcome Measure of Genetic Counseling Visit Completion
时间窗: Genetic counseling visit completion was evaluated daily, up to 13.5 months
Measure difference in genetic counseling visit completion rate between study arms
次要结局
- Patient Reported Outcome of Genetic Counseling-specific Empowerment(GOS survey administered within 7 days prior to and post-genetic counseling visit)
- Number of Participants That Made an Informed Choice(MMIC survey administered within 7 days post-genetic counseling and genetic testing uptake during scheduled genetic counseling appointment)
- Clinical Outcome Measure of Genetic Testing Completion(Sample for testing provided within 45 days of visit without sample failure)
研究者
Sara Pirzadeh-Miller
Associate Director, Cancer Genetics Program
University of Texas Southwestern Medical Center