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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Malignant Solid Neoplasm; Breast Carcinoma; Lung Carcinoma; Colorectal Carcinoma; Ovarian Carcinoma; Pancreatic Carcinoma; Prostate Carcinoma
• Intervention / Treatment: Other: Best Practice; Other: Survey Administration; Other: Educational Intervention; Other: Educational Intervention; Procedure: Genomic Profile

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.

• Study Type: Interventional
• Enrollment (Actual): 465
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Duarte, California, United States, 91010
      • City of Hope Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm I (usual care); Patients receive education pamphlet about WES and have their genomics test results returned by their clinician in a typical manner.	Other: Best Practice; Receive usual care; Other Names: standard of care; standard therapy; Other: Survey Administration; Ancillary studies
Experimental: Arm II (genomics test results, HOPE-Genomics); 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.	Other: Survey Administration; Ancillary studies; Other: Educational Intervention; View HOPE-Genomics tool after genomic test results are available; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational; Other: Educational Intervention; View HOPE-Genomics before sequencing results are available; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational; Procedure: Genomic Profile; Receive genomics test results; Other Names: genetic profile; Genome Profile; Genomic Profiling; Genomic Test; Genomic Testing
Experimental: Arm III (HOPE-Genomics, genomics test results); 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.	Other: Survey Administration; Ancillary studies; Other: Educational Intervention; View HOPE-Genomics tool after genomic test results are available; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational; Other: Educational Intervention; View HOPE-Genomics before sequencing results are available; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recall rates of personal genomic results	Recall rates of personal genomic results for Arms 2 and 3 of the study will be pooled together so that the main comparison is a two-sample test of proportions between patients under usual care (Arm 1) versus (vs.) patients with any exposure to the Helping Oncology Patients Explore (HOPE)-Genomics tool (Arms 2/3).	Up to 9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operationalization of contextual guideline concordant care	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.	Up to 12-month period after results disclosure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Test-related distress	Patients will be assessed at 3 post-disclosure time points (T1-T3) using the Psychological Adaptation to Genetic Information Scale Certainty Scale and the Feelings About genomiC Testing Results. Will summarize test-related distress at each time point, as well as change score. Will examine baseline characteristics to evaluate the potential for bias. In addition to complete case analysis, sensitivity analyses (e.g., using weighted methods) may occur to evaluate bias. Will use clustered Wilcoxon test for mean score comparison between groups at each time point. In addition, mean change in score from T1 to T3 will be modeled using generalized estimating equation model adjusting for patient characteristics.	Up to 9 months
General genomic knowledge	Will compare the pre/post test scores between the intervention group (Arm 3) and the control groups (Arms 1/2) The pre/post test scores will be calculated by taking the difference in score between pre/post tests and then comparing the mean differences with an independent T-test between control groups (Arms 1/2) versus the exclusive exposure to the HOPE-Genomics tool educational content (Arm 3).	Up to 9 months
Genetically-guided care	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).	Up to 9 months
HOPE-Genomics tool usage	Will analyze the web-log of user visits (e.g., number of viewing sessions, page views and use of interactive elements).	Up to 9 months

Collaborators and Investigators

• Sponsor: City of Hope Medical Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Stacy W Gray, City of Hope Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2021
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: May 24, 2021
• First Submitted That Met QC Criteria: May 24, 2021
• First Posted (Actual): May 27, 2021

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Endocrine System Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Endocrine Gland Neoplasms; Breast Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Pancreatic Diseases; Breast Neoplasms; Carcinoma; Colorectal Neoplasms; Pancreatic Neoplasms
• Other Study ID Numbers: 20430 (Other Identifier: City of Hope Medical Center); P30CA033572 (U.S. NIH Grant/Contract); NCI-2021-03114 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No