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NCT Number: NCT04905082

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Best Practice

Other

Receive usual care

Other names: standard of care, standard therapy

Educational Intervention

Other

View HOPE-Genomics tool after genomic test results are available

Other names: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Genomic Profile

Procedure

Receive genomics test results

Other names: genetic profile, Genome Profile, Genomic Profiling, Genomic Test, Genomic Testing

Survey Administration

Other

Ancillary studies

Primary outcomes

  1. Recall Rates of Personal Genomic Results

    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.

Secondary outcomes

  1. Operationalization of Contextual Guideline Concordant Care

    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.

Other outcomes

  1. Test-related Distress

    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.

  2. Genetically-guided Care

    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).

  3. HOPE-Genomics Tool Usage

    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).

  4. Change in Genomic Knowledge Score

    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.

Sponsors and collaborators

Lead sponsor

City of Hope Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2026
First posted
May 27, 2021
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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