Breast CarcinomaNCT04905082

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

A study testing Best Practice, Educational Intervention and Genomic Profile in people with Breast Carcinoma and Colorectal Carcinoma, run by City of Hope Medical Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Breast Carcinoma, Colorectal Carcinoma, Lung Carcinoma
What is being tested?: Best Practice, Educational Intervention and Genomic Profile
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 465 participants
Where: 1 siteUnited States
Study dates: 30 Dec 2021to 1 Oct 2026
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

Are unable to provide informed consent

Trial locations and contacts

1 site in 1 country.

United States1 site

City of Hope Medical Center
Duarte, California, 91010

Other trials in United States

About this study

Official title: 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.

Read the detailed description

PRIMARY OBJECTIVES:

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.

Conditions: Breast Carcinoma, Colorectal Carcinoma, Lung Carcinoma, Malignant Solid Neoplasm, Ovarian Carcinoma, Pancreatic Carcinoma
Being tested: Best Practice, Educational Intervention, Genomic Profile, Survey Administration
Medical subject headings: Breast Neoplasms, Colorectal Neoplasms, Lung Neoplasms, Ovarian Neoplasms, Pancreatic Neoplasms, Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Best PracticeOther
Also called standard of care, standard therapy
Receive usual care
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
View HOPE-Genomics tool after genomic test results are available
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
View HOPE-Genomics before sequencing results are available
Genomic ProfileProcedure or surgery
Also called genetic profile, Genome Profile, Genomic Profiling, Genomic Test
Receive genomics test results
Survey AdministrationOther
Ancillary studies

Study groups in NCT04905082
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: Other: Educational Intervention; Other: Survey Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Up to 3 months

Secondary outcomes (1)

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.
Measured: Up to 12-month period after results disclosure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Dec 20211 Oct 2026

First posted27 May 2021
Study start30 Dec 2021
Primary completion14 Aug 2024
Study completion1 Oct 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Breast CarcinomaStudies of the same condition, open and under way.
More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 465 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04905082
Sponsor's protocol ID: 20430
Other IDs: NCI-2021-03114, 20430, P30CA033572
Status last verified: Aug 2026
First submitted: 24 May 2021
Last updated: 11 Sep 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Solomon IB, Luong M, Currey M, Labib S, Tang S, Martinez J, Suarez C, Qiao R, Mak A, Cheung F, Manookian R, Xiao Y, Garcia M, Seshadri A, Jinadu J, Kim M, Martinez R, White P, Martinez F, Rout R, Sharifara A, Zhou C, Boyd P, Davey S, Gray SW. Rationale and study design for a randomized clinical trial of HOPE-Genomics, a web-based intervention to improve cancer patients' understanding of genomic testing results. Contemp Clin Trials. 2026 Aug;167:108358. doi: 10.1016/j.cct.2026.108358. Epub 2026 May 30.
PubMed 42217668

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

All Breast Carcinoma trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Helping Oncology Patients Explore-Genomics (HOPE-Genomics) Web Tool Randomized Clinical Trial
ClinicalTrials.gov ID: NCT04905082
Acronym / sponsor ID: 20430
Conditions: Breast Carcinoma, Colorectal Carcinoma, Lung Carcinoma, Malignant Solid Neoplasm, Ovarian Carcinoma, Pancreatic Carcinoma
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 465 participants (actual)
Lead sponsor: City of Hope Medical CenterUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: 30 Dec 2021 (actual)
Primary completion: 14 Aug 2024 (actual)
Study completion: 1 Oct 2026 (estimated)
First posted: 27 May 2021 (actual)
Results: Posted 11 Dec 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PRIMARY OBJECTIVES:

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.

After completion of study intervention, patients are followed up at 2 weeks, 3 and 9 months after receiving genomic test results.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Arm I (usual care)	Active comparator	Other: Best Practice, Other: Survey AdministrationPatients receive education pamphlet about WES and have their genomics test results returned by their clinician in a typical manner.
Arm II (genomics test results, HOPE-Genomics)	Experimental	Other: Educational Intervention, Procedure: Genomic Profile, Other: Survey AdministrationPatients 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 (HOPE-Genomics, genomics test results)	Experimental	Other: Educational Intervention, Other: Survey AdministrationPatients 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (1 listed)

Are unable to provide informed consent

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Best PracticeAlso: standard of care, standard therapyReceive usual care	Other	Arm I (usual care)
Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalView HOPE-Genomics tool after genomic test results are available	Other	Arm II (genomics test results, HOPE-Genomics)
Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalView HOPE-Genomics before sequencing results are available	Other	Arm III (HOPE-Genomics, genomics test results)
Genomic ProfileAlso: genetic profile, Genome Profile, Genomic Profiling, Genomic TestReceive genomics test results	Procedure or surgery	Arm II (genomics test results, HOPE-Genomics)
Survey AdministrationAncillary studies	Other	Arm I (usual care), Arm II (genomics test results, HOPE-Genomics), Arm III (HOPE-Genomics, genomics test results)

Primary outcome

Recall Rates of Personal Genomic Results
Time frame: Up to 3 months
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.

1 secondary outcome

Operationalization of Contextual Guideline Concordant Care
Time frame: Up to 12-month period after results disclosure

Results and safety

Results posted to the registry on 11 Dec 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm I (Usual Care)	155	104
Arm II (Genomics Test Results, HOPE-Genomics)	155	109
Arm III (HOPE-Genomics, Genomics Test Results)	155	105

Primary outcome: Recall Rates of Personal Genomic Results

Time frame: Up to 3 months. Count of participants. Unit: Participants

Measure	Arm I (Usual Care) n = 132	Arm II (Genomics Test Results, HOPE-Genomics) Plus Arm III (HOPE-Genomics, Genomics Test Results) n = 137	Arm III (HOPE-Genomics, Genomics Test Results) n = 131
Recalled Germline Testing	89	82	83
Not Recalled Germline Testing	43	55	48

Population analysed: For the primary analysis, only patients who responded to the question regarding completion of germline testing in either the 10-day or 3-month survey were included. Therefore, the number of patients analyzed differs from the total number of randomized participants.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Since this is not a drug trial, there was no specific timepoint that was monitored for an adverse event to be recorded and patients were not assessed for specific adverse events. However, 19 patients died during the study, not due to study participation. The time frame where each participant was monitored/assessed for death was up till 9 months after their genetic testing.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm I (Usual Care)	0 of 0	0 of 0	6 of 155
Arm II (Genomics Test Results, HOPE-Genomics)	0 of 0	0 of 0	8 of 155
Arm III (HOPE-Genomics, Genomics Test Results)	0 of 0	0 of 0	5 of 155

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42217668Solomon IB, Luong M, Currey M, Labib S, Tang S, Martinez J, Suarez C, Qiao R, Mak A, Cheung F, Manookian R, Xiao Y, Garcia M, Seshadri A, Jinadu J, Kim M, Martinez R, White P, Martinez F, Rout R, Sharifara A, Zhou C, Boyd P, Davey S, Gray SW. Rationale and study design for a randomized clinical trial of HOPE-Genomics, a web-based intervention to improve cancer patients' understanding of genomic testing results. Contemp Clin Trials. 2026 Aug;167:108358. doi: 10.1016/j.cct.2026.108358. Epub 2026 May 30.

Related trials for Breast Carcinoma

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Stacy W Gray principal investigator

City of Hope Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Best Practice, Educational Intervention and Genomic Profile in people with Breast Carcinoma and Colorectal Carcinoma, run by City of Hope Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recall Rates of Personal Genomic Results (time frame: Up to 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04905082, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.