HOPE – Genomická intervence pro zlepšení znalostí pacientů s rakovinou o genomice

Patients receive education pamphlet about WES and have their genomics test results returned by their clinician in a typical manner.

Ancillary studies

Receive usual care

• Standartní péče
• standardní terapie

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.

Ancillary studies

View HOPE-Genomics tool after genomic test results are available

• Výchova k intervenci
• Intervence vzděláváním
• Intervence prostřednictvím vzdělávání
• Intervence, Vzdělávací

View HOPE-Genomics before sequencing results are available

• Výchova k intervenci
• Intervence vzděláváním
• Intervence prostřednictvím vzdělávání
• Intervence, Vzdělávací

Receive genomics test results

• genetický profil
• Profil genomu
• Genomické profilování
• Genomický test
• Genomické testování

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.

Ancillary studies

View HOPE-Genomics tool after genomic test results are available

• Výchova k intervenci
• Intervence vzděláváním
• Intervence prostřednictvím vzdělávání
• Intervence, Vzdělávací

View HOPE-Genomics before sequencing results are available

• Výchova k intervenci
• Intervence vzděláváním
• Intervence prostřednictvím vzdělávání
• Intervence, Vzdělávací

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.

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.

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.

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).

Will analyze the web-log of user visits (e.g., number of viewing sessions, page views and use of interactive elements).

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.