A Randomized Hybrid Type I Effectiveness-Implementation Study of an eHealth Delivery Alternative for Cancer Genetic Testing for Hereditary Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Patient Reported Outcome Measurement Information System (PROMIS)
研究概览
简要总结
This randomized non-inferiority study will use a 2x2 design where traditional standard-of-care pre-test (visit 1) and post-test (visit 2: disclosure) counseling delivered by a genetic counselor are replaced with a self-directed web-based eHealth intervention to provide critical data to inform optimal ways to deliver clinical genetic testing in eligible individuals, while maintaining quality of care and favorable cognitive, affective and behavioral outcomes.
详细描述
Germline cancer genetic testing has become a standard evidence-based practice, with established risk reduction and cancer screening guidelines for genetic carriers. Access to genetic specialists is limited in many areas in the US, and the traditional medical delivery model of pre- and post-test counseling with a genetic professional will not support the rising indications for genetic testing. Recent data from the National Health Interview Survey found that <20% of eligible patients with a personal or family history of breast or ovarian cancer underwent genetic testing. Thus, there is an urgent need to consider alternative delivery models to increase access and uptake of genetic testing, while maintaining adequate patient cognitive, affective and behavioral outcomes.
This study aims to evaluate the effectiveness of offering web-based eHealth delivery alternatives of pre/post-test genetic counseling to provide equal or improved timely uptake of genetic services and testing, and short-term cognitive (e.g. understanding), affective (e.g. distress and uncertainty) and behavioral (risk reducing and screening behaviors and communication to providers and relatives) outcomes in patients with barriers to genetic testing as compared to the traditional two-visit delivery model with a genetic counselor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years of age or older
- •Speak and understand English
- •Male or Female
- •No prior germline genetic testing
- •Meet current National Comprehensive Cancer Network (NCCN) guidelines for germline genetic testing
排除标准
- •Communication difficulties such as:
- •Uncorrected or uncompensated hearing and/or vision impairment
- •Uncorrected or uncompensated speech defects
- •Uncontrolled psychiatric/mental condition or severe physical, neurological or cognitive deficits rendering individual unable to understand study goals and tasks
研究组 & 干预措施
ARM B
Visit 1/Pre-Test Session - Standard-of-Care Pre-Test Counseling with a genetic counselor.
Visit 2/Disclosure Session - Self-directed web-based eHealth result disclosure intervention.
干预措施: Standard of Care (Other)
ARM A
Visit 1/Pre-Test Session - Standard-of-Care Pre-Test Counseling with a genetic counselor.
Visit 2/Disclosure Session - Standard-of-Care Post-Test Counseling with a genetic counselor.
干预措施: Standard of Care (Other)
ARM B
Visit 1/Pre-Test Session - Standard-of-Care Pre-Test Counseling with a genetic counselor.
Visit 2/Disclosure Session - Self-directed web-based eHealth result disclosure intervention.
干预措施: Pre-Test Intervention (Other)
ARM C
Visit 1/Pre-Test Session - Self-directed web-based eHealth pre-test session intervention.
Visit 2/Disclosure Session - Standard-of-Care Post-Test Counseling with a genetic counselor.
干预措施: Standard of Care (Other)
ARM C
Visit 1/Pre-Test Session - Self-directed web-based eHealth pre-test session intervention.
Visit 2/Disclosure Session - Standard-of-Care Post-Test Counseling with a genetic counselor.
干预措施: Post-Test Intervention (Other)
ARM D
Visit 1/Pre-Test Session - Self-directed web-based eHealth pre-test session intervention.
Visit 2/Disclosure Session - Self-directed web-based eHealth result disclosure intervention.
干预措施: Pre-Test Intervention (Other)
ARM D
Visit 1/Pre-Test Session - Self-directed web-based eHealth pre-test session intervention.
Visit 2/Disclosure Session - Self-directed web-based eHealth result disclosure intervention.
干预措施: Post-Test Intervention (Other)
结局指标
主要结局
Patient Reported Outcome Measurement Information System (PROMIS)
时间窗: Through study completion, an average of 1 year
Change in General Anxiety - Score Range = 4-20, Lower score = Better outcome
The KnowGene Scale
时间窗: Through study completion, an average of 1 year
Change in Knowledge - Score Range = 0-16, Higher score = Better outcome
Uptake of Genetic Services
时间窗: Through study completion, an average of 1 year
Testing uptake per arm - Yes/No
次要结局
- Provider Time(Through study completion, an average of 1 year)
- Satisfaction with genetic services(Through study completion, an average of 1 year)
- Decisional Regret Scale(Through study completion, an average of 1 year)
- Patient Reported Outcome Measurement Information System (PROMIS)(Through study completion, an average of 1 year)
- Multi-dimensional Impact of Cancer Risk Assessment Questionnaire (MICRA)(Through study completion, an average of 1 year)
- Impact of Events Scale (IES)(Through study completion, an average of 1 year)