A Randomized Study of an eHealth Delivery Alternative for Cancer Genetic Testing for Hereditary Predisposition in Metastatic Breast, Ovarian, Prostate and Pancreatic Cancer Patients
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Cancer
- 发起方
- Abramson Cancer Center at Penn Medicine
- 入组人数
- 256
- 试验地点
- 1
- 主要终点
- Change in Knowledge
- 状态
- 已完成
- 最后更新
- 9个月前
概览
简要总结
This study aims to determine if web-based eHealth delivery of pre-test and/or post-test counseling in cancer patients and/or those at risk for cancer can provide equal or improved cognitive and affective outcomes when compared to the standard of care delivery model.
详细描述
Cancer genetic testing has become a standard evidence-based practice, with established risk reduction and cancer screening guidelines for genetic carriers. With FDA approval for PARP inhibitors in patients with advanced breast, ovarian, pancreatic and prostate cancer, there is an additional therapeutic rationale for testing all breast, ovarian, pancreatic and prostate cancer patients for germline genetic mutations. Yet, access to genetic specialists is limited in many area, and the traditional model of pre- and post-test counseling with a genetic professional will not support the rising indications for cancer genetic testing. Thus, there is an urgent need to consider alternative delivery models to increase access and uptake of testing, while maintaining adequate patient outcomes. This study aims to assess if traditional pre-test (visit 1) and post-test (visit 2: disclosure) counseling delivered by a genetic counselor can be replaced with a self-directed web-based eHealth intervention to provide critical data to inform optimal ways to deliver cancer genetic testing in patients with breast, ovarian, pancreatic and prostate cancer, while maintaining quality of care and favorable cognitive, affective and behavioral outcomes. Specific Aim 1: To determine if web-based eHealth delivery of pre-test and/or post-test counseling can provide equal or improved cognitive and affective short-term and 6-month outcomes as compared to the two-visit standard of care delivery model with a genetic counselor. The investigator's primary outcomes will be changes in knowledge and anxiety. Secondary outcomes will include uptake of testing, depression, cancer specific distress, uncertainty and health behaviors and provider time.
研究者
入排标准
入选标准
- •18 years of age or older
- •Speak and understand English
- •Male or Female
- •A personal history of one or more of the following:
- •metastatic breast cancer
- •advanced ovarian cancer (Stage III-IV)
- •metastatic pancreatic cancer
- •metastatic prostate cancer
- •Naive to previous cancer 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
结局指标
主要结局
Change in Knowledge
时间窗: Baseline - Within 7 days of Visit 2
Knowledge Scale - Score Range = 0-16 Increased change score indicates increase in knowledge (better).
Change in Anxiety
时间窗: Baseline - Within 7 days of Visit 2
Patient-Reported Outcomes Measurement Information Systems (PROMIS) - Score Range = 4-20 Decreased score change indicates a decrease in anxiety (better).
次要结局
- Change in Cancer Specific Distress(Baseline - Within 7 days of Visit 2)
- Change in Depression(Baseline - Within 7 days of Visit 2)
- Change in Health Behaviors(Within 7 days of Visit 2 - 6-Month Follow-Up)
- Provider Time(Within 7 days of Standard of Care V2)
- Change in Uncertainty(Within 7 days of Visit 2 - 6-Month Follow-Up)
- Frequency of Uptake of Testing(Within 7 days of Visit 1)