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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04905082
Enrollment
465
Registered
2021-05-27
Start date
2021-12-30
Completion date
2026-06-15
Last updated
2026-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

OTHERBest Practice

Receive usual care

OTHEREducational Intervention

View HOPE-Genomics tool after genomic test results are available

Receive genomics test results

OTHERSurvey Administration

Ancillary studies

Sponsors

City of Hope Medical Center
Lead SponsorOTHER
National Cancer Institute (NCI)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Recall Rates of Personal Genomic ResultsUp to 3 monthsRecall 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.

Secondary

MeasureTime frameDescription
Operationalization of Contextual Guideline Concordant CareUp to 12-month period after results disclosureIn 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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORStacy W Gray

City of Hope Comprehensive Cancer Center

Participant flow

Participants by arm

ArmCount
Arm I (Usual Care)
Patients receive education pamphlet about WES and have their genomics test results returned by their clinician in a typical manner.
155
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.
155
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.
155
Total465

Baseline characteristics

CharacteristicTotalArm III (HOPE-Genomics, Genomics Test Results)Arm I (Usual Care)Arm II (Genomics Test Results, HOPE-Genomics)
Age, Continuous61 Year64 Year59 Year61 Year
Education
College 1 Year to 3 Years (Some College or Technical School)
131 Participants43 Participants43 Participants45 Participants
Education
College 4 years or More (College Graduate)
137 Participants44 Participants45 Participants48 Participants
Education
Doctoral Degree
45 Participants18 Participants13 Participants14 Participants
Education
Grade 12 or GED
40 Participants19 Participants11 Participants10 Participants
Education
Grades 1 through 8
1 Participants0 Participants0 Participants1 Participants
Education
Grades 9 through 11
6 Participants2 Participants4 Participants0 Participants
Education
Master's Degree
79 Participants25 Participants25 Participants29 Participants
Education
Unknown or Not Reported
26 Participants4 Participants14 Participants8 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
115 Participants36 Participants42 Participants37 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
344 Participants118 Participants110 Participants116 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
6 Participants1 Participants3 Participants2 Participants
Race (NIH/OMB)
American Indian or Alaska Native
5 Participants3 Participants1 Participants1 Participants
Race (NIH/OMB)
Asian
56 Participants19 Participants21 Participants16 Participants
Race (NIH/OMB)
Black or African American
17 Participants6 Participants6 Participants5 Participants
Race (NIH/OMB)
More than one race
22 Participants6 Participants11 Participants5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
8 Participants4 Participants2 Participants2 Participants
Race (NIH/OMB)
White
357 Participants117 Participants114 Participants126 Participants
Sex: Female, Male
Female
338 Participants116 Participants112 Participants110 Participants
Sex: Female, Male
Male
127 Participants39 Participants43 Participants45 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
6 / 1558 / 1555 / 155
other
Total, other adverse events
0 / 00 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 00 / 0

Outcome results

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.

Time frame: Up to 3 months

Population: 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.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Arm I (Usual Care)Recall Rates of Personal Genomic ResultsRecalled Germline Testing89 Participants
Arm I (Usual Care)Recall Rates of Personal Genomic ResultsNot Recalled Germline Testing43 Participants
Arm II (Genomics Test Results, HOPE-Genomics) Plus Arm III (HOPE-Genomics, Genomics Test Results)Recall Rates of Personal Genomic ResultsRecalled Germline Testing82 Participants
Arm II (Genomics Test Results, HOPE-Genomics) Plus Arm III (HOPE-Genomics, Genomics Test Results)Recall Rates of Personal Genomic ResultsNot Recalled Germline Testing55 Participants
Arm III (HOPE-Genomics, Genomics Test Results)Recall Rates of Personal Genomic ResultsRecalled Germline Testing83 Participants
Arm III (HOPE-Genomics, Genomics Test Results)Recall Rates of Personal Genomic ResultsNot Recalled Germline Testing48 Participants
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.

Time frame: Up to 12-month period after results disclosure

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.

Time frame: baseline, pre-test (approximately 2-3 days after baseline), 10 days and 3 months

Population: Only participants who answered at least half of the knowledge questions for corresponding surveys were included in the analysis.

ArmMeasureGroupValue (MEAN)Dispersion
Arm I (Usual Care)Change in Genomic Knowledge ScoreChange from baseline to 3 months1.63 PointStandard Error 17.48
Arm I (Usual Care)Change in Genomic Knowledge ScoreChange from baseline to 10 days1.24 PointStandard Error 16.92
Arm I (Usual Care)Change in Genomic Knowledge ScoreChange from baseline to pre-test (approximately 2-3 days after baseline)2.76 PointStandard Error 14.19
Arm II (Genomics Test Results, HOPE-Genomics) Plus Arm III (HOPE-Genomics, Genomics Test Results)Change in Genomic Knowledge ScoreChange from baseline to 10 days4.86 PointStandard Error 16.85
Arm II (Genomics Test Results, HOPE-Genomics) Plus Arm III (HOPE-Genomics, Genomics Test Results)Change in Genomic Knowledge ScoreChange from baseline to pre-test (approximately 2-3 days after baseline)1.67 PointStandard Error 13.36
Arm II (Genomics Test Results, HOPE-Genomics) Plus Arm III (HOPE-Genomics, Genomics Test Results)Change in Genomic Knowledge ScoreChange from baseline to 3 months3.12 PointStandard Error 18.59
Arm III (HOPE-Genomics, Genomics Test Results)Change in Genomic Knowledge ScoreChange from baseline to pre-test (approximately 2-3 days after baseline)7.39 PointStandard Error 13.88
Arm III (HOPE-Genomics, Genomics Test Results)Change in Genomic Knowledge ScoreChange from baseline to 3 months6.04 PointStandard Error 16.32
Arm III (HOPE-Genomics, Genomics Test Results)Change in Genomic Knowledge ScoreChange from baseline to 10 days7.44 PointStandard Error 16.95
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).

Time frame: Up to 9 months

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).

Time frame: Up to 9 months

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.

Time frame: 10 days, 3 months, 9 months

Population: Only participants who answered distress-related questions were included in the analysis.

ArmMeasureGroupValue (MEAN)Dispersion
Arm I (Usual Care)Test-related DistressFACToR Score at 10-Day11.07 scores on a scaleStandard Deviation 6.29
Arm I (Usual Care)Test-related DistressFACToR Score at 3-Month12.32 scores on a scaleStandard Deviation 6.83
Arm I (Usual Care)Test-related DistressPAGIS Score at 9 Months22.29 scores on a scaleStandard Deviation 7.12
Arm I (Usual Care)Test-related DistressFACToR Score at 9-Month12.61 scores on a scaleStandard Deviation 7.11
Arm I (Usual Care)Test-related DistressPAGIS Score at 10 Days24.76 scores on a scaleStandard Deviation 6.74
Arm I (Usual Care)Test-related DistressPAGIS Score at 3 Months25.11 scores on a scaleStandard Deviation 7.38
Arm II (Genomics Test Results, HOPE-Genomics) Plus Arm III (HOPE-Genomics, Genomics Test Results)Test-related DistressPAGIS Score at 10 Days24.25 scores on a scaleStandard Deviation 7.11
Arm II (Genomics Test Results, HOPE-Genomics) Plus Arm III (HOPE-Genomics, Genomics Test Results)Test-related DistressPAGIS Score at 3 Months24.54 scores on a scaleStandard Deviation 7.23
Arm II (Genomics Test Results, HOPE-Genomics) Plus Arm III (HOPE-Genomics, Genomics Test Results)Test-related DistressFACToR Score at 9-Month11.97 scores on a scaleStandard Deviation 6.31
Arm II (Genomics Test Results, HOPE-Genomics) Plus Arm III (HOPE-Genomics, Genomics Test Results)Test-related DistressFACToR Score at 10-Day12.37 scores on a scaleStandard Deviation 6.82
Arm II (Genomics Test Results, HOPE-Genomics) Plus Arm III (HOPE-Genomics, Genomics Test Results)Test-related DistressPAGIS Score at 9 Months23.11 scores on a scaleStandard Deviation 7.42
Arm II (Genomics Test Results, HOPE-Genomics) Plus Arm III (HOPE-Genomics, Genomics Test Results)Test-related DistressFACToR Score at 3-Month13.20 scores on a scaleStandard Deviation 7.41
Arm III (HOPE-Genomics, Genomics Test Results)Test-related DistressPAGIS Score at 9 Months24.39 scores on a scaleStandard Deviation 8.34
Arm III (HOPE-Genomics, Genomics Test Results)Test-related DistressFACToR Score at 10-Day11.17 scores on a scaleStandard Deviation 7.93
Arm III (HOPE-Genomics, Genomics Test Results)Test-related DistressFACToR Score at 9-Month12.19 scores on a scaleStandard Deviation 7.01
Arm III (HOPE-Genomics, Genomics Test Results)Test-related DistressPAGIS Score at 10 Days26.53 scores on a scaleStandard Deviation 6.95
Arm III (HOPE-Genomics, Genomics Test Results)Test-related DistressPAGIS Score at 3 Months26.11 scores on a scaleStandard Deviation 7.3
Arm III (HOPE-Genomics, Genomics Test Results)Test-related DistressFACToR Score at 3-Month12.48 scores on a scaleStandard Deviation 7.47

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026