HOPE-Genomics Intervention for the Improvement of Cancer Patient Knowledge of Genomics
NCT ID: NCT04905082
Last Updated: 2025-12-11
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
NA
465 participants
INTERVENTIONAL
2021-12-30
2025-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Arm I (usual care)
Patients receive education pamphlet about WES and have their genomics test results returned by their clinician in a typical manner.
Survey Administration
Ancillary studies
Best Practice
Receive usual care
Arm II (genomics test results, HOPE-Genomics)
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.
Genomic Profile
Receive genomics test results
Survey Administration
Ancillary studies
Educational Intervention
View HOPE-Genomics tool after genomic test results are available
Arm III (HOPE-Genomics, genomics test results)
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.
Survey Administration
Ancillary studies
Educational Intervention
View HOPE-Genomics before sequencing results are available
Interventions
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Genomic Profile
Receive genomics test results
Survey Administration
Ancillary studies
Best Practice
Receive usual care
Educational Intervention
View HOPE-Genomics tool after genomic test results are available
Educational Intervention
View HOPE-Genomics before sequencing results are available
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
City of Hope Medical Center
OTHER
Responsible Party
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Principal Investigators
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Stacy W Gray
Role: PRINCIPAL_INVESTIGATOR
City of Hope Comprehensive Cancer Center
Locations
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City of Hope Medical Center
Duarte, California, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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NCI-2021-03114
Identifier Type: REGISTRY
Identifier Source: secondary_id
20430
Identifier Type: OTHER
Identifier Source: secondary_id
20430
Identifier Type: -
Identifier Source: org_study_id
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