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

City of Hope

Status: Active, not recruiting

Conditions: Colorectal Carcinoma; Prostate Carcinoma; Ovarian Carcinoma; Lung Carcinoma; Malignant Solid Neoplasm; Breast Carcinoma; Pancreatic Carcinoma

Treatments: Other: Best Practice; Other: Survey Administration; Procedure: Genomic Profile; Other: Educational Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04905082

NCI-2021-03114 (Registry Identifier)

P30CA033572 (U.S. NIH Grant/Contract)

20430

Details and patient eligibility

About

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.

Full 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.

Enrollment: 465 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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465 participants in 3 patient groups

Arm I (usual care)

Active Comparator group

Description:

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

Treatment:

Other: Survey Administration

Other: Best Practice

Arm II (genomics test results, HOPE-Genomics)

Experimental group

Description:

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.

Treatment:

Other: Educational Intervention

Procedure: Genomic Profile

Other: Educational Intervention

Other: Survey Administration

Arm III (HOPE-Genomics, genomics test results)

Experimental group

Description:

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.

Treatment:

Other: Educational Intervention

Other: Educational Intervention

Other: Survey Administration