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

NCT04905082 | Active Not Recruiting Results DMC

• 3 other identifiers: 20430NCI-2021-03114P30CA033572
• Study Type: interventional
• Target: 465
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Recall Rates of Personal Genomic Results

  Recall rate refers to the proportion of patients who accurately remembered whether they had undergone genetic testing, as reported in the 10-day follow-up survey. If a patient's response at the 10-day mark was unavailable, their answer from the 3-month survey was used as a substitute. This metric helps assess how well patients retained and understood information about their genetic testing experience shortly after receiving their results.

  Up to 3 months

Secondary Outcomes (1)

• Operationalization of Contextual Guideline Concordant Care

  Up to 12-month period after results disclosure

Other Outcomes (4)

• Test-related Distress

  10 days, 3 months, 9 months

• Genetically-guided Care

  Up to 9 months

• HOPE-Genomics Tool Usage

  Up to 9 months

Study Arms (3)

Arm I (usual care)

ACTIVE COMPARATOR

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

Other: Best Practice; Other: Survey Administration

Arm II (genomics test results, HOPE-Genomics)

EXPERIMENTAL

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: Educational Intervention; Procedure: Genomic Profile; Other: Survey Administration

Arm III (HOPE-Genomics, genomics test results)

EXPERIMENTAL

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: Educational Intervention; Other: Survey Administration

Interventions

Best Practice OTHER

Receive usual care

Also known as: standard of care, standard therapy

Arm I (usual care)

Educational Intervention OTHER

View HOPE-Genomics tool after genomic test results are available

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Arm II (genomics test results, HOPE-Genomics)

Genomic Profile PROCEDURE

Receive genomics test results

Also known as: genetic profile, Genome Profile, Genomic Profiling, Genomic Test, Genomic Testing

Arm II (genomics test results, HOPE-Genomics)

Survey Administration OTHER

Ancillary studies

Arm I (usual care); Arm II (genomics test results, HOPE-Genomics); Arm III (HOPE-Genomics, genomics test results)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Are unable to provide informed consent

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Colorectal Neoplasms; Lung Neoplasms; Ovarian Neoplasms; Pancreatic Neoplasms; Prostatic Neoplasms

Interventions

Practice Guidelines as Topic; Standard of Care; Early Intervention, Educational; Educational Status; Methods; Genetic Profile

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Pancreatic Diseases; Genital Neoplasms, Male; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Investigative Techniques; Genetic Background; Genetic Phenomena

Results Point of Contact

• Title: Stacy W. Gray, MD. AM.
• Organization: City of Hope

stagray@coh.org

626-715-4425

Study Officials

• Stacy W Gray

  City of Hope Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2021
• First Posted: May 27, 2021
• Study Start: December 30, 2021
• Primary Completion: August 14, 2024
• Study Completion (Estimated): June 15, 2026
• Last Updated: March 24, 2026
• Results First Posted: December 11, 2025

Record last verified: 2026-03

Locations

US (1)