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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-03114 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 20430 | Other Identifier | City of Hope Medical Center | |
| P30CA033572 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (usual care) | Active Comparator | Patients receive education pamphlet about WES and have their genomics test results returned by their clinician in a typical manner. |
|
| Arm II (genomics test results, HOPE-Genomics) | Experimental | 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 (HOPE-Genomics, genomics test results) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Best Practice | Other | Receive usual care |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Recall Rates of Personal Genomic Results | 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. | Up to 3 months |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Test-related Distress | The psychosocial impact of genetic testing and patient uncertainty were assessed at 10 days, 3 months and 9 months using both the adapted PAGIS Certainty Scale and the FACToR. The FACToR was a 12-item measure that included four subscales: privacy concerns, uncertainty, test-related distress, and positive experiences. The overall FACToR score is computed by summing all items after reverse scoring the positivity subscale, resulting in a total range of 0 to 48. Higher total scores indicate greater psychosocial impact, which is considered a worse outcome. The PAGIS Certainty Subscale consists of 6 items scored on a 1-6 scale, with a total range of 6-36. Higher scores reflect greater certainty and better psychological adaptation to genetic information, which is considered a positive outcome. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stacy W Gray | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Medical Center | Duarte | California | 91010 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42217668 | Derived | Solomon IB, Luong M, Currey M, Labib S, Tang S, Martinez J, Suarez C, Qiao R, Mak A, Cheung F, Manookian R, Xiao Y, Garcia M, Seshadri A, Jinadu J, Kim M, Martinez R, White P, Martinez F, Rout R, Sharifara A, Zhou C, Boyd P, Davey S, Gray SW. Rationale and study design for a randomized clinical trial of HOPE-Genomics, a web-based intervention to improve cancer patients' understanding of genomic testing results. Contemp Clin Trials. 2026 May 30;167:108358. doi: 10.1016/j.cct.2026.108358. Online ahead of print. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm I (Usual Care) | Patients receive education pamphlet about WES and have their genomics test results returned by their clinician in a typical manner. |
| FG001 | Arm II (Genomics Test Results, HOPE-Genomics) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 17, 2023 |
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| Educational Intervention | Other | View HOPE-Genomics tool after genomic test results are available |
|
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| Educational Intervention | Other | View HOPE-Genomics before sequencing results are available |
|
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| Genomic Profile | Procedure | Receive genomics test results |
|
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| Survey Administration | Other | Ancillary studies |
|
| Up to 12-month period after results disclosure |
| 10 days, 3 months, 9 months |
| Genetically-guided Care | 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). | Up to 9 months |
| HOPE-Genomics Tool Usage | Will analyze the web-log of user visits (e.g., number of viewing sessions, page views and use of interactive elements). | Up to 9 months |
| Change in Genomic Knowledge Score | Genomic knowledge was assessed using a modified 35-item instrument comprising three subscales: cancer genomics knowledge, understanding of the use of genetic testing results in cancer care, and germline sequencing knowledge. Overall knowledge scores were calculated for patients who completed more than half of the items in the full measure. Each score was expressed as the percentage of correct responses out of the total number of questions answered in that category, with scores ranging from 0 to 100. The change in pre/post scores was calculated by taking the differences in knowledge scores from baseline to pre-test, 10-days and 3 months survey. | baseline, pre-test (approximately 2-3 days after baseline), 10 days and 3 months |
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.
| FG002 | 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. |
| Pre-test Survey (Approximately 2-3 Days After Baseline) |
|
| Ten-day Visit |
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| Three-month Survey |
|
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm I (Usual Care) | Patients receive education pamphlet about WES and have their genomics test results returned by their clinician in a typical manner. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Median | Inter-Quartile Range | Year |
| |||||||||||||||
| Education | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Recall Rates of Personal Genomic Results | 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. | For the primary analysis, only patients who responded to the question regarding completion of germline testing in either the 10-day or 3-month survey were included. Therefore, the number of patients analyzed differs from the total number of randomized participants. | Posted | Count of Participants | Participants | Up to 3 months |
|
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| ||||||||||||||||||||||||||||||||||
| Secondary | 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. | Not Posted | Up to 12-month period after results disclosure | Participants | |||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Test-related Distress | The psychosocial impact of genetic testing and patient uncertainty were assessed at 10 days, 3 months and 9 months using both the adapted PAGIS Certainty Scale and the FACToR. The FACToR was a 12-item measure that included four subscales: privacy concerns, uncertainty, test-related distress, and positive experiences. The overall FACToR score is computed by summing all items after reverse scoring the positivity subscale, resulting in a total range of 0 to 48. Higher total scores indicate greater psychosocial impact, which is considered a worse outcome. The PAGIS Certainty Subscale consists of 6 items scored on a 1-6 scale, with a total range of 6-36. Higher scores reflect greater certainty and better psychological adaptation to genetic information, which is considered a positive outcome. | Only participants who answered distress-related questions were included in the analysis. | Posted | Mean | Standard Deviation | scores on a scale | 10 days, 3 months, 9 months |
| |||||||||||||||||||||||||||||||||||
| Other Pre-specified | Genetically-guided Care | 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). | Not Posted | Up to 9 months | Participants | |||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | HOPE-Genomics Tool Usage | Will analyze the web-log of user visits (e.g., number of viewing sessions, page views and use of interactive elements). | Not Posted | Up to 9 months | Participants | |||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change in Genomic Knowledge Score | Genomic knowledge was assessed using a modified 35-item instrument comprising three subscales: cancer genomics knowledge, understanding of the use of genetic testing results in cancer care, and germline sequencing knowledge. Overall knowledge scores were calculated for patients who completed more than half of the items in the full measure. Each score was expressed as the percentage of correct responses out of the total number of questions answered in that category, with scores ranging from 0 to 100. The change in pre/post scores was calculated by taking the differences in knowledge scores from baseline to pre-test, 10-days and 3 months survey. | Only participants who answered at least half of the knowledge questions for corresponding surveys were included in the analysis. | Posted | Mean | Standard Error | Point | baseline, pre-test (approximately 2-3 days after baseline), 10 days and 3 months |
|
Since this is not a drug trial, there was no specific timepoint that was monitored for an adverse event to be recorded and patients were not assessed for specific adverse events. However, 19 patients died during the study, not due to study participation. The time frame where each participant was monitored/assessed for death was up till 9 months after their genetic testing.
Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed. Please see above regarding adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm I (Usual Care) | Patients receive education pamphlet about WES and have their genomics test results returned by their clinician in a typical manner. | 6 | 155 | 0 | 0 | 0 | 0 |
| EG001 | 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. | 8 | 155 | 0 | 0 | 0 | 0 |
| EG002 | 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. | 5 | 155 | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stacy W. Gray, MD. AM. | City of Hope | 626-715-4425 | stagray@coh.org |
| Nov 10, 2025 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 23, 2023 | Mar 13, 2024 | ICF_000.pdf |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D015179 | Colorectal Neoplasms |
| D008175 | Lung Neoplasms |
| D010051 | Ovarian Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D010182 | Pancreatic Diseases |
| D005834 | Genital Neoplasms, Male |
| D005832 | Genital Diseases, Male |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D017410 | Practice Guidelines as Topic |
| D059039 | Standard of Care |
| D018479 | Early Intervention, Educational |
| D004522 | Educational Status |
| D008722 | Methods |
| D000076610 | Genetic Profile |
| ID | Term |
|---|---|
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D019984 | Quality Indicators, Health Care |
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D011314 | Preventive Health Services |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D008919 | Investigative Techniques |
| D000068617 | Genetic Background |
| D055614 | Genetic Phenomena |
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| Male |
|
| Asian |
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| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Grades 9 through 11 |
|
| Grade 12 or GED |
|
| College 1 Year to 3 Years (Some College or Technical School) |
|
| College 4 years or More (College Graduate) |
|
| Master's Degree |
|
| Doctoral Degree |
|
| Unknown or Not Reported |
|
| OG002 | 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. |
|
|
| 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. |
|
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