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

Breast Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04905082
• Other study ID #: 20430
• Secondary ID: NCI-2021-0311420
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 30, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: March 2024
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 465
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Carcinoma
• Breast Neoplasms
• Carcinoma
• Colorectal Carcinoma
• Colorectal Neoplasms
• Lung Carcinoma
• Malignant Solid Neoplasm
• Ovarian Carcinoma
• Pancreatic Carcinoma
• Pancreatic Neoplasms
• Prostate Carcinoma

Intervention

Other:
• Best Practice
Receive usual care
• Educational Intervention
View HOPE-Genomics tool after genomic test results are available
• Educational Intervention
View HOPE-Genomics before sequencing results are available

Procedure:
• Genomic Profile
Receive genomics test results

Other:
• Survey Administration
Ancillary studies

Locations

Country	Name	City	State
United States	City of Hope Medical Center	Duarte	California

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Primary	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	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