HOPE-Genomics Intervention for the Improvement of Cancer Patient Knowledge of Genomics

Study Overview
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Brief Summary
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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
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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.

Official Title
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Helping Oncology Patients Explore-Genomics (HOPE-Genomics) Web Tool Randomized Clinical Trial

Conditions
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Breast Carcinoma, Colorectal Carcinoma, Lung Carcinoma, Malignant Solid Neoplasm, Ovarian Carcinoma, Pancreatic Carcinoma, Prostate Carcinoma

Intervention / Treatment
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* Other: Best Practice
* Other: Educational Intervention
* Other: Educational Intervention
* Procedure: Genomic Profile
* Other: Survey Administration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm I (usual care)<br>Patients receive education pamphlet about WES and have their genomics test results returned by their clinician in a typical manner. | Other: Best Practice<br>* Receive usual care<br>* Other names: standard therapy;Other: Survey Administration<br>* Ancillary studies<br>|
| Experimental: Arm II (genomics test results, HOPE-Genomics)<br>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. | Other: Educational Intervention<br>* View HOPE-Genomics tool after genomic test results are available<br>* Other names: Intervention, Educational;Procedure: Genomic Profile<br>* Receive genomics test results<br>* Other names: Genomic Testing;Other: Survey Administration<br>* Ancillary studies<br>|
| Experimental: Arm III (HOPE-Genomics, genomics test results)<br>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. | Other: Educational Intervention<br>* View HOPE-Genomics before sequencing results are available<br>* Other names: Intervention, Educational;Other: Survey Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recall rates of personal genomic results | Recall rates of personal genomic results for Arms 2 and 3 of the study will be pooled together so that the main comparison is a two-sample test of proportions between patients under usual care (Arm 1) versus (vs.) patients with any exposure to the Helping Oncology Patients Explore (HOPE)-Genomics tool (Arms 2/3). | Up to 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operationalization of contextual guideline concordant care | In the primary analysis, we will assess the uptake of contextualized guideline-concordant care taking into account clinically relevant, patient specific circumstances. Will use clinical characteristics from the electronic health record (EHR) to assign each patient to clinical category for which there are discrete National Comprehensive Cancer Network (NCCN) recommendations. Using patient self-reported baseline/T1 and EHR data, following sequencing disclosure, we will create a summary genetically-guided care variable ranging from 0-100%. In the secondary analyses, will define guideline concordant as meeting >= 75% of recommended guidelines. | Up to 12-month period after results disclosure |