Educational Intervention for Cancer Knowledge

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: City of Hope Medical Center

Disqualifiers: Unable to provide informed consent

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a web-based tool, HOPE-Genomics, to determine if it helps cancer patients better understand their genomic test results. The goal is to improve knowledge about genomics (the study of genes and their functions) and enhance overall patient care. Participants with cancers such as lung, breast, or colorectal, who are undergoing genomic testing, might be suitable candidates. The trial involves different groups: one receives usual care, while others use the HOPE-Genomics tool either before or after receiving their test results. As an unphased trial, this study offers patients a unique opportunity to contribute to innovative research that could enhance future patient care.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems to focus on education rather than treatment, so you may not need to change your medications, but it's best to confirm with the trial coordinators.

What prior data suggests that the HOPE-Genomics tool is safe for improving patient knowledge?

Research shows that HOPE-Genomics is an online tool designed to help cancer patients understand genetic testing. This tool aims to simplify the interpretation of genetic test results and provide information about cancer. As an educational tool, HOPE-Genomics is not a medicine or physical treatment and thus lacks the usual safety concerns associated with medical treatments.

No known negative effects result from using HOPE-Genomics. The main goal is to increase knowledge, and current evidence suggests it is safe for users. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the HOPE-Genomics tool because it aims to enhance patient understanding of genomics test results in cancer care. Unlike standard educational resources, which typically involve receiving results from a clinician with a pamphlet, HOPE-Genomics provides an interactive, digital experience that helps patients grasp complex genetic information more easily. This tool could empower patients by making genomics more accessible and personalized, potentially leading to better-informed health decisions and outcomes.

What evidence suggests that the HOPE-Genomics tool is effective for improving cancer genomic knowledge?

Research shows that the HOPE-Genomics tool helps cancer patients better understand genetic testing and their results. In this trial, participants in Arm II will receive their genomics test results from both their clinician and the HOPE-Genomics tool, while those in Arm III will view the HOPE-Genomics tool before their sequencing results are available. Studies have found that patients using this online tool gain a clearer grasp of cancer genetics. This increases their knowledge about genetics and improves their overall care. The tool encourages patients to engage more with genetic information, aiding them in making more informed treatment choices. Early findings suggest that using HOPE-Genomics could enhance how patients and their families understand complex genetic information. ^{1 2 3 6 7}

Who Is on the Research Team?

Stacy W. Gray

Principal Investigator

City of Hope Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for English-speaking adults over 18 with lung, breast, colorectal, pancreatic, ovarian or prostate cancer who are undergoing genomic sequencing. They must be enrolled in a specific review board and have a performance status indicating they can care for themselves.

Inclusion Criteria

I have been diagnosed with lung, breast, colorectal, pancreatic, ovarian, or prostate cancer.

My cancer has been genetically sequenced.

I am able to care for myself and perform daily activities.

Exclusion Criteria

I am unable to understand and give consent for treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants are randomized to receive either usual care, genomics test results with HOPE-Genomics tool, or HOPE-Genomics tool with pre-test education

1 session

1 visit (in-person or virtual)

Follow-up

Participants are monitored for recall rates of genomic results, guideline-concordant care, test-related distress, and general genomic knowledge

Up to 12 months

Follow-up at 2 weeks, 3 months, and 9 months

What Are the Treatments Tested in This Trial?

Interventions

• HOPE-Genomics

Trial Overview The trial tests the HOPE-Genomics web tool designed to educate cancer patients about their own genomic test results and general genomics knowledge. It aims to see if this improves understanding of personal testing outcomes and overall patient-centered care quality.

How Is the Trial Designed?

Group I: Arm III (HOPE-Genomics, genomics test results) Experimental Treatment 2 Interventions

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.

Group II: Arm II (genomics test results, HOPE-Genomics) Experimental Treatment 3 Interventions

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.

Group III: Arm I (usual care) Active Control 2 Interventions

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

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04905082?term=AREA%5BBasicSearch%5D(genomic)&rank=4

HOPE-Genomics Intervention for the Improvement of ... This clinical trial studies the effectiveness of a web-based cancer education tool called Helping Oncology Patients Explore Genomics (HOPE- Genomics ) in ...

2. digital.ahrq.gov digital.ahrq.gov/sites/default/files/docs/citation/r21hs024984-gray-final-report-2019.pdf

HOPE-Genomics: Empowering Cancer Patients through ... The goal of this project was to design a cancer genome sequencing report to improve patient understanding of cancer genetics and their test ...

3. withpower.com withpower.com/trial/educational-intervention-for-cancer-knowledge-69783

Educational Intervention for Cancer Knowledge 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 ...

4. cityofhope.org cityofhope.org/research/beckman-research-institute/population-sciences/clinical-cancer-genomics/ccg-research-program

Clinical Cancer Genomics Research Program This study is the general research protocol for City of Hope, which allows us to use patient data and leftover biospecimens for future unspecified research.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7446413/

Development and Usability of a Web-Based Patient-Facing ... The HOPE-Genomics tool is an e-health tool that holds promise to promote greater patient and family member engagement with genomic information and precision ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8950486/

A Web Screening on Training Initiatives in Cancer ... The disruptive advances in genomics contributed to achieve higher levels of precision in the diagnosis and treatment of cancer.

7. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2021-03114

HOPE-Genomics Intervention for the Improvement of ... This clinical trial studies the effectiveness of a web-based cancer education tool called Helping Oncology Patients Explore Genomics (HOPE-Genomics)