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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04905082
Recruitment Status : Recruiting
First Posted : May 27, 2021
Last Update Posted : February 15, 2023
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center

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.

Condition or disease Intervention/treatment Phase
Breast Carcinoma Colorectal Carcinoma Lung Carcinoma Malignant Solid Neoplasm Ovarian Carcinoma Pancreatic Carcinoma Prostate Carcinoma Other: Best Practice Other: Educational Intervention Procedure: Genomic Profile Other: Survey Administration Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 435 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Helping Oncology Patients Explore-Genomics (HOPE-Genomics) Web Tool Randomized Clinical Trial
Actual Study Start Date : December 30, 2021
Estimated Primary Completion Date : December 28, 2023
Estimated Study Completion Date : December 31, 2024


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: 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

Procedure: Genomic Profile
Receive genomics test results
Other Names:
  • genetic profile
  • Genome Profile
  • Genomic Profiling
  • Genomic Test
  • Genomic Testing

Other: Survey Administration
Ancillary studies

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: Educational Intervention
View HOPE-Genomics before sequencing results are available
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational

Other: Survey Administration
Ancillary studies




Primary Outcome Measures :
  1. Recall rates of personal genomic results [ Time Frame: Up to 9 months ]
    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).


Secondary Outcome Measures :
  1. Operationalization of contextual guideline concordant care [ Time Frame: Up to 12-month period after results disclosure ]
    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.


Other Outcome Measures:
  1. Test-related distress [ Time Frame: Up to 9 months ]
    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.

  2. General genomic knowledge [ Time Frame: Up to 9 months ]
    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).

  3. Genetically-guided care [ Time Frame: Up to 9 months ]
    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).

  4. HOPE-Genomics tool usage [ Time Frame: Up to 9 months ]
    Will analyze the web-log of user visits (e.g., number of viewing sessions, page views and use of interactive elements).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04905082


Locations
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United States, California
City of Hope Medical Center Recruiting
Duarte, California, United States, 91010
Contact: Stacy W. Gray    626-256-4673 ext 86639    stagray@coh.org   
Principal Investigator: Stacy W. Gray         
Sponsors and Collaborators
City of Hope Medical Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Stacy W Gray City of Hope Comprehensive Cancer Center
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Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT04905082    
Other Study ID Numbers: 20430
NCI-2021-03114 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
20430 ( Other Identifier: City of Hope Medical Center )
P30CA033572 ( U.S. NIH Grant/Contract )
First Posted: May 27, 2021    Key Record Dates
Last Update Posted: February 15, 2023
Last Verified: February 2023

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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
Additional relevant MeSH terms:
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Carcinoma
Breast Neoplasms
Colorectal Neoplasms
Pancreatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Pancreatic Diseases