Helping Oncology Patients Explore-Genomics (HOPE-Genomics) Web Tool Randomized Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Carcinoma
- Sponsor
- City of Hope Medical Center
- Enrollment
- 465
- Locations
- 1
- Primary Endpoint
- Recall Rates of Personal Genomic Results
- Status
- Active, not recruiting
- Last Updated
- last month
Overview
Brief Summary
This clinical trial studies the effectiveness of a web-based cancer education tool called Helping Oncology Patients Explore Genomics (HOPE-Genomics) in improving patient knowledge of personal genomic testing results and cancer and genomics in general. HOPE-Genomics is a web-based education tool that teaches cancer/leukemia patients, and patients who may be at high-risk for developing cancer, about genomic testing and provide patients with information about their own genomic test results. The HOPE-Genomics tool may improve patient's genomic knowledge and quality of patient-centered care. In addition, it may also improve education and care quality for future patients.
Detailed Description
PRIMARY OBJECTIVES: I. Test the efficacy of the HOPE-Genomics intervention in improving patient knowledge of genomics. II. Test the efficacy of the HOPE-Genomics intervention in improving patient receipt of guideline-concordant care. OUTLINE: Patients are randomized to 1 of 3 arms. ARM I (USUAL CARE): Patients receive education pamphlet about whole-genome sequencing (WES) and have their genomics test results returned by their clinician in a typical manner. ARM II (RETURN OF RESULTS ONLY): Patients receive their genomics test results both from their clinician and from the HOPE-Genomics tool. Patients then view HOPE-Genomics tool over 15-20 minutes after their results are available. ARM III (RETURN OF RESULTS PLUS PRE-TEST EDUCATION): Patients view HOPE-Genomics tool (containing educational content) over 15-20 minutes before their sequencing results are available. Patients also receive their genomics test results both from their clinician and from the HOPE-Genomics tool. After completion of study intervention, patients are followed up at 2 weeks, 3 and 9 months after receiving genomic test results.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Are enrolled in City of Hope (COH) Institutional Review Board (IRB) 07047
- •Have a diagnosis of lung, breast, colorectal, pancreatic, ovarian or prostate cancer
- •Having somatic, germline or paired somatic/germline sequencing
- •Are fluent in English
- •Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- •Are \>= 18 years old
Exclusion Criteria
- •Are unable to provide informed consent
Outcomes
Primary Outcomes
Recall Rates of Personal Genomic Results
Time Frame: Up to 3 months
Recall rate refers to the proportion of patients who accurately remembered whether they had undergone genetic testing, as reported in the 10-day follow-up survey. If a patient's response at the 10-day mark was unavailable, their answer from the 3-month survey was used as a substitute. This metric helps assess how well patients retained and understood information about their genetic testing experience shortly after receiving their results.
Secondary Outcomes
- Operationalization of Contextual Guideline Concordant Care(Up to 12-month period after results disclosure)