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

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.

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.

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

Patients receive education pamphlet about WES and have their genomics test results returned by their clinician in a typical manner.

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.

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.

Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

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).

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.

Patients will be assessed at 3 post-disclosure time points (T1-T3) using the Psychological Adaptation to Genetic Information Scale Certainty Scale and the Feelings About genomiC Testing Results. Will summarize test-related distress at each time point, as well as change score. Will examine baseline characteristics to evaluate the potential for bias. In addition to complete case analysis, sensitivity analyses (e.g., using weighted methods) may occur to evaluate bias. Will use clustered Wilcoxon test for mean score comparison between groups at each time point. In addition, mean change in score from T1 to T3 will be modeled using generalized estimating equation model adjusting for patient characteristics.

Will compare the pre/post test scores between the intervention group (Arm 3) and the control groups (Arms 1/2) The pre/post test scores will be calculated by taking the difference in score between pre/post tests and then comparing the mean differences with an independent T-test between control groups (Arms 1/2) versus the exclusive exposure to the HOPE-Genomics tool educational content (Arm 3).

In exploratory analyses related to Aim 2 (i.e. receipt of contextual guideline-concordant care), will also operationalize the secondary outcome in an additional way: Categories of genetically-guided care: Will evaluate patients' receipt of 1) treatment recommended by provider based on sequencing (any/none), 2) patients' sharing of sequencing results with family members (any/none), and 3) patients' consultation with genetic counseling/ recommended specialist (any/none).

Will analyze the web-log of user visits (e.g., number of viewing sessions, page views and use of interactive elements).

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