Breast Carcinoma, Colorectal Carcinoma, Lung Carcinoma, Malignant Solid Neoplasm, Ovarian Carcinoma, Pancreatic Carcinoma, Prostate Carcinoma
Conditions
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
Receive usual care
View HOPE-Genomics tool after genomic test results are available
Receive genomics test results
Ancillary studies
Sponsors
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Recall Rates of Personal Genomic Results | Up to 3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
City of Hope Comprehensive Cancer Center
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 465 |
Baseline characteristics
| Characteristic | Total | Arm III (HOPE-Genomics, Genomics Test Results) | Arm I (Usual Care) | Arm II (Genomics Test Results, HOPE-Genomics) |
|---|---|---|---|---|
| Age, Continuous | 61 Year | 64 Year | 59 Year | 61 Year |
| Education College 1 Year to 3 Years (Some College or Technical School) | 131 Participants | 43 Participants | 43 Participants | 45 Participants |
| Education College 4 years or More (College Graduate) | 137 Participants | 44 Participants | 45 Participants | 48 Participants |
| Education Doctoral Degree | 45 Participants | 18 Participants | 13 Participants | 14 Participants |
| Education Grade 12 or GED | 40 Participants | 19 Participants | 11 Participants | 10 Participants |
| Education Grades 1 through 8 | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Education Grades 9 through 11 | 6 Participants | 2 Participants | 4 Participants | 0 Participants |
| Education Master's Degree | 79 Participants | 25 Participants | 25 Participants | 29 Participants |
| Education Unknown or Not Reported | 26 Participants | 4 Participants | 14 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 115 Participants | 36 Participants | 42 Participants | 37 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 344 Participants | 118 Participants | 110 Participants | 116 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 6 Participants | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 5 Participants | 3 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 56 Participants | 19 Participants | 21 Participants | 16 Participants |
| Race (NIH/OMB) Black or African American | 17 Participants | 6 Participants | 6 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 22 Participants | 6 Participants | 11 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 8 Participants | 4 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 357 Participants | 117 Participants | 114 Participants | 126 Participants |
| Sex: Female, Male Female | 338 Participants | 116 Participants | 112 Participants | 110 Participants |
| Sex: Female, Male Male | 127 Participants | 39 Participants | 43 Participants | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 6 / 155 | 8 / 155 | 5 / 155 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm I (Usual Care) | Recall Rates of Personal Genomic Results | Recalled Germline Testing | 89 Participants |
| Arm I (Usual Care) | Recall Rates of Personal Genomic Results | Not Recalled Germline Testing | 43 Participants |
| Arm II (Genomics Test Results, HOPE-Genomics) Plus Arm III (HOPE-Genomics, Genomics Test Results) | Recall Rates of Personal Genomic Results | Recalled Germline Testing | 82 Participants |
| Arm II (Genomics Test Results, HOPE-Genomics) Plus Arm III (HOPE-Genomics, Genomics Test Results) | Recall Rates of Personal Genomic Results | Not Recalled Germline Testing | 55 Participants |
| Arm III (HOPE-Genomics, Genomics Test Results) | Recall Rates of Personal Genomic Results | Recalled Germline Testing | 83 Participants |
| Arm III (HOPE-Genomics, Genomics Test Results) | Recall Rates of Personal Genomic Results | Not Recalled Germline Testing | 48 Participants |
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
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm I (Usual Care) | Change in Genomic Knowledge Score | Change from baseline to 3 months | 1.63 Point | Standard Error 17.48 |
| Arm I (Usual Care) | Change in Genomic Knowledge Score | Change from baseline to 10 days | 1.24 Point | Standard Error 16.92 |
| Arm I (Usual Care) | Change in Genomic Knowledge Score | Change from baseline to pre-test (approximately 2-3 days after baseline) | 2.76 Point | Standard Error 14.19 |
| Arm II (Genomics Test Results, HOPE-Genomics) Plus Arm III (HOPE-Genomics, Genomics Test Results) | Change in Genomic Knowledge Score | Change from baseline to 10 days | 4.86 Point | Standard Error 16.85 |
| Arm II (Genomics Test Results, HOPE-Genomics) Plus Arm III (HOPE-Genomics, Genomics Test Results) | Change in Genomic Knowledge Score | Change from baseline to pre-test (approximately 2-3 days after baseline) | 1.67 Point | Standard Error 13.36 |
| Arm II (Genomics Test Results, HOPE-Genomics) Plus Arm III (HOPE-Genomics, Genomics Test Results) | Change in Genomic Knowledge Score | Change from baseline to 3 months | 3.12 Point | Standard Error 18.59 |
| Arm III (HOPE-Genomics, Genomics Test Results) | Change in Genomic Knowledge Score | Change from baseline to pre-test (approximately 2-3 days after baseline) | 7.39 Point | Standard Error 13.88 |
| Arm III (HOPE-Genomics, Genomics Test Results) | Change in Genomic Knowledge Score | Change from baseline to 3 months | 6.04 Point | Standard Error 16.32 |
| Arm III (HOPE-Genomics, Genomics Test Results) | Change in Genomic Knowledge Score | Change from baseline to 10 days | 7.44 Point | Standard Error 16.95 |
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
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
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm I (Usual Care) | Test-related Distress | FACToR Score at 10-Day | 11.07 scores on a scale | Standard Deviation 6.29 |
| Arm I (Usual Care) | Test-related Distress | FACToR Score at 3-Month | 12.32 scores on a scale | Standard Deviation 6.83 |
| Arm I (Usual Care) | Test-related Distress | PAGIS Score at 9 Months | 22.29 scores on a scale | Standard Deviation 7.12 |
| Arm I (Usual Care) | Test-related Distress | FACToR Score at 9-Month | 12.61 scores on a scale | Standard Deviation 7.11 |
| Arm I (Usual Care) | Test-related Distress | PAGIS Score at 10 Days | 24.76 scores on a scale | Standard Deviation 6.74 |
| Arm I (Usual Care) | Test-related Distress | PAGIS Score at 3 Months | 25.11 scores on a scale | Standard Deviation 7.38 |
| Arm II (Genomics Test Results, HOPE-Genomics) Plus Arm III (HOPE-Genomics, Genomics Test Results) | Test-related Distress | PAGIS Score at 10 Days | 24.25 scores on a scale | Standard Deviation 7.11 |
| Arm II (Genomics Test Results, HOPE-Genomics) Plus Arm III (HOPE-Genomics, Genomics Test Results) | Test-related Distress | PAGIS Score at 3 Months | 24.54 scores on a scale | Standard Deviation 7.23 |
| Arm II (Genomics Test Results, HOPE-Genomics) Plus Arm III (HOPE-Genomics, Genomics Test Results) | Test-related Distress | FACToR Score at 9-Month | 11.97 scores on a scale | Standard Deviation 6.31 |
| Arm II (Genomics Test Results, HOPE-Genomics) Plus Arm III (HOPE-Genomics, Genomics Test Results) | Test-related Distress | FACToR Score at 10-Day | 12.37 scores on a scale | Standard Deviation 6.82 |
| Arm II (Genomics Test Results, HOPE-Genomics) Plus Arm III (HOPE-Genomics, Genomics Test Results) | Test-related Distress | PAGIS Score at 9 Months | 23.11 scores on a scale | Standard Deviation 7.42 |
| Arm II (Genomics Test Results, HOPE-Genomics) Plus Arm III (HOPE-Genomics, Genomics Test Results) | Test-related Distress | FACToR Score at 3-Month | 13.20 scores on a scale | Standard Deviation 7.41 |
| Arm III (HOPE-Genomics, Genomics Test Results) | Test-related Distress | PAGIS Score at 9 Months | 24.39 scores on a scale | Standard Deviation 8.34 |
| Arm III (HOPE-Genomics, Genomics Test Results) | Test-related Distress | FACToR Score at 10-Day | 11.17 scores on a scale | Standard Deviation 7.93 |
| Arm III (HOPE-Genomics, Genomics Test Results) | Test-related Distress | FACToR Score at 9-Month | 12.19 scores on a scale | Standard Deviation 7.01 |
| Arm III (HOPE-Genomics, Genomics Test Results) | Test-related Distress | PAGIS Score at 10 Days | 26.53 scores on a scale | Standard Deviation 6.95 |
| Arm III (HOPE-Genomics, Genomics Test Results) | Test-related Distress | PAGIS Score at 3 Months | 26.11 scores on a scale | Standard Deviation 7.3 |
| Arm III (HOPE-Genomics, Genomics Test Results) | Test-related Distress | FACToR Score at 3-Month | 12.48 scores on a scale | Standard Deviation 7.47 |