Clinical trial NCT04905082: HOPE-Genomics Intervention for the Improvement of Cancer Patient Knowledge of Genomics
Official title: Helping Oncology Patients Explore-Genomics (HOPE-Genomics) Web Tool Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Carcinoma
Colorectal Carcinoma
Lung Carcinoma
Malignant Solid Neoplasm
Ovarian Carcinoma
Pancreatic Carcinoma
Prostate Carcinoma
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-05-27
Enrollment: 465
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Recall rates of personal genomic results
timeFrame: Up to 9 months
Secondary outcomes:
measure: Operationalization of contextual guideline concordant care
timeFrame: Up to 12-month period after results disclosure
Other outcomes:
measure: Test-related distress
timeFrame: Up to 9 months
measure: General genomic knowledge
timeFrame: Up to 9 months
measure: Genetically-guided care
timeFrame: Up to 9 months
measure: HOPE-Genomics tool usage
timeFrame: Up to 9 months
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
Study officials:
affiliation: City of Hope Comprehensive Cancer Center
name: Stacy W Gray
role: PRINCIPAL_INVESTIGATOR
References: