HOPE-Genomics Intervention for the Improvement of Cancer Patient Knowledge of Genomics
- Conditions
- Pancreatic CarcinomaProstate CarcinomaColorectal CarcinomaMalignant Solid NeoplasmOvarian CarcinomaBreast CarcinomaLung Carcinoma
- Interventions
- Other: Best PracticeOther: Educational InterventionOther: Survey AdministrationProcedure: Genomic Profile
- Registration Number
- NCT04905082
- Lead Sponsor
- City of Hope Medical Center
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 465
- 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
- Are unable to provide informed consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm I (usual care) Best Practice Patients receive education pamphlet about WES and have their genomics test results returned by their clinician in a typical manner. Arm I (usual care) Survey Administration Patients receive education pamphlet about WES and have their genomics test results returned by their clinician in a typical manner. Arm III (HOPE-Genomics, genomics test results) Survey Administration 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. Arm III (HOPE-Genomics, genomics test results) Educational Intervention 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. Arm II (genomics test results, HOPE-Genomics) Educational Intervention 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 II (genomics test results, HOPE-Genomics) Genomic Profile 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 II (genomics test results, HOPE-Genomics) Survey Administration 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.
- Primary Outcome Measures
Name Time Method Recall rates of personal genomic results Up to 9 months 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).
- Secondary Outcome Measures
Name Time Method Operationalization of contextual guideline concordant care Up to 12-month period after results disclosure 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.
Trial Locations
- Locations (1)
City of Hope Medical Center
🇺🇸Duarte, California, United States