City of Hope Medical Center
Duarte, California, 91010, United States
NCT Number: NCT04905082
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Not applicable
Duarte, California, 91010, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Receive usual care
Other names: standard of care, standard therapy
View HOPE-Genomics tool after genomic test results are available
Other names: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Receive genomics test results
Other names: genetic profile, Genome Profile, Genomic Profiling, Genomic Test, Genomic Testing
Ancillary studies
Time frame: 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.
Time frame: 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.
Time frame: 10 days, 3 months, 9 months
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: Up to 9 months
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
Will analyze the web-log of user visits (e.g., number of viewing sessions, page views and use of interactive elements).
Time frame: baseline, pre-test (approximately 2-3 days after baseline), 10 days and 3 months
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.
City of Hope Medical Center
Other
Helping Oncology Patients Explore-Genomics (HOPE-Genomics) Web Tool Randomized Clinical Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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