eHealth Delivery Alternative for Cancer Genetic Testing for Hereditary Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pre-Test Intervention, Standard of Care, Post-Test Intervention.
- Who it may be relevant to
- Registry conditions: Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Randomized Hybrid Type I Effectiveness-Implementation Study of an eHealth Delivery Alternative for Cancer Genetic Testing for Hereditary Cancer
Overview
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.
Detailed description
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.
Interventions
- Other Pre-Test Intervention
Secure and accessible by private code only, the web-based intervention will provide users with a the results of their clinical genetic testing results and a detailed summary of what those results mean. Additionally, an individualized summary will also be included. - Other Standard of Care
Standard of Care with a Genetic Counselor by Remote Services - Other Post-Test Intervention
Secure and accessible by private code only, the web-based intervention will provide users with a the results of their clinical genetic testing results and a detailed summary of what those results mean. Additionally, an individualized summary will also be included.
Primary outcome measures
- The KnowGene Scale [Time frame: Through study completion, an average of 1 year]
- Patient Reported Outcome Measurement Information System (PROMIS) [Time frame: Through study completion, an average of 1 year]
- Uptake of Genetic Services [Time frame: Through study completion, an average of 1 year]
Secondary outcome measures (6)
- Patient Reported Outcome Measurement Information System (PROMIS) [Time frame: Through study completion, an average of 1 year]
- Impact of Events Scale (IES) [Time frame: Through study completion, an average of 1 year]
- Multi-dimensional Impact of Cancer Risk Assessment Questionnaire (MICRA) [Time frame: Through study completion, an average of 1 year]
- Satisfaction with genetic services [Time frame: Through study completion, an average of 1 year]
- Decisional Regret Scale [Time frame: Through study completion, an average of 1 year]
- Provider Time [Time frame: Through study completion, an average of 1 year]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
-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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- Abramson Cancer Center at the University of Pennsylvania — Philadelphia
Publications
- Mastaglio E, Egleston B, Lee KT, Fetzer D, Brown S, Domchek SM, Fleisher L, Wen KY, Wagner L, Roberts JS, Cacioppo C, Christiansen J, Howe S, Wood EM, Weinberg M, Karpink K, Selmani E, Feng J, John S, Schweickert K, McLeod B, Bradbury AR. A Randomized Hybrid Type I Effectiveness-Implementation Study of an eHealth Delivery Alternative for Cancer Genetic Testing for Hereditary Cancer (eREACH2): stud PMID 41332807
Identifiers
NCT: NCT05427240 · 13021 · 850242