Hematopoietic and Lymphoid System NeoplasmNCT05772130
Provider-Mediated Communication of Genetic Testing Results to At-Risk Relatives of Cancer Patients to Improve Genetic Counseling and Testing Rates, Family HOPE Study
A study testing Best Practice, Electronic Health Record Review and Personal Contact in people with Hematopoietic and Lymphoid System Neoplasm and Hereditary Malignant Neoplasm, run by City of Hope Medical Center at 1 site in United States.
Trial summary
This clinical trial tests whether provider-mediated communication of genetic testing results to at-risk relatives of cancer patients can help improve genetic counseling and testing rates. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hematopoietic and Lymphoid System Neoplasm, Hereditary Malignant Neoplasm, Malignant Solid Neoplasm
- What is being tested?
- Best Practice, Electronic Health Record Review and Personal Contact
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2023to 21 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- PATIENTS: Enrolled in City of Hope (COH) institutional review board (IRB) 07047 or have been seen by COH Genetics for genetic testing
- PATIENTS: Have an pathogenic/ likely pathogenic germline variant
- PATIENTS: Fluent in English
- PATIENTS: Age >= 18 years
- PATIENTS: Willing to provide contact information for eligible first-degree relatives
- PATIENTS: >= 2 first-degree relatives that are eligible for genetic testing and reside in the United States of America
Show all 12Show fewer
- FIRST-DEGREE RELATIVES: Proband is a COH patient and has consented to this study
- FIRST-DEGREE RELATIVES: First-degree relative of proband
- FIRST-DEGREE RELATIVES: Resides within the United States
- FIRST-DEGREE RELATIVES: Has not undergone genetic testing for the known familial variant
- FIRST-DEGREE RELATIVES: Are fluent in English
- FIRST-DEGREE RELATIVES: Age >= 18 years
Who cannot join
- PATIENTS: Unable to provide informed consent
- PATIENTS: =< 2 at-risk first-degree relatives who are eligible for genetic testing and/or reside within the United States
- PATIENTS: Unwilling to provide contact information for family members
- FIRST-DEGREE RELATIVES: Unable or unwilling to provide informed consent
- FIRST-DEGREE RELATIVES: Have undergone genetic testing for the known familial variant
- FIRST-DEGREE RELATIVES: Resides outside of the United States
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
City of Hope Medical Center
Duarte, California, 91010
Stacy W. Gray, 626-218-8662, stagray@coh.org
Stacy W. Gray
About this study
Official title: Family HOPE Study (Hereditary Lynch Syndrome Opportunities for Participation &Amp; Engagement)
This clinical trial tests whether provider-mediated communication of genetic testing results to at-risk relatives of cancer patients can help improve genetic counseling and testing rates. Approximately 15% of people with cancer have an inherited form of cancer due to changes in a gene that they have inherited from one of their parents. These changes increase a person's risk for developing cancer. Most people who have an inherited harmful change in a cancer risk gene don't know that they have it and are therefore not able to get the health care that they need. The primary reason for this problem has been a lack of genetic counseling and testing for cancer patients and patients with a strong family history of cancer. Another reason for this lack of awareness is that, when cancer runs in a family, the patient who carries the gene change usually has to communicate the genetic risk information to their family members. When this process doesn't work well, family members may not know that they need to get genetic testing and then may not get potentially life-saving care. Provider-mediated contact to discuss genetic test results may help improve rates of genetic testing among at-risk relatives of patients with a family cancer syndrome.
Read the detailed description
PRIMARY OBJECTIVES:
- Improve rates of family member cascade testing. II. Evaluate the psychosocial impact of provider-mediated contact to communicate genetic testing results.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Patients receive a family letter and their genomic test report to share with at-risk first degree relatives on study.
ARM II: Patients receive a family letter and their genomic test report to share with at-risk first degree relatives and relatives also receive provider-mediated contact to discuss genetic results on study.
- Conditions
- Hematopoietic and Lymphoid System Neoplasm, Hereditary Malignant Neoplasm, Malignant Solid Neoplasm
- Being tested
- Best Practice, Electronic Health Record Review, Personal Contact, Survey Administration
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 family letter and genomic test report
Electronic Health Record ReviewOther
Ancillary studies
Personal ContactBehavioural
Also called Contact
Receive family letter and genomic test report with provider-mediated contact
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (usual care) | Active comparator | Patients receive a family letter and their genomic test report to share with at-risk first degree relatives on study. Receives: Other: Best Practice; Other: Electronic Health Record Review; Other: Survey Administration |
| Arm II (provider-mediated contact) | Experimental | Patients receive a family letter and their genomic test report to share with at-risk first degree relatives and relatives also receive provider-mediated contact to discuss genetic results on study. Receives: Other: Electronic Health Record Review; Behavioral: Personal Contact; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of uptake of cascade testing among patients' first-degree at-risk relatives
Will calculate descriptive statistics first, including the mean, median and standard deviation of the number of the first-degree and secondary-degree at-risk relatives. We will then compare the proportion of identified relatives who completed genetic testing between the intervention and the control arms with a one-sided Cochran-Mantel-Haenszel test. Type I error of 0.05 will be used and descriptive statistics will be calculated for all exploratory outcomes along with 95% confidence intervals. All statistical testing and calculation of confidence intervals will adjust for intra-proband correlation.
Measured: Up to 9 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start10 Mar 2023
- Primary completion21 Dec 2026 (estimated)
- Study completion21 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic and Lymphoid System NeoplasmStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Stacy W Gray, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05772130
- Sponsor's protocol ID
- 22261
- Other IDs
- NCI-2023-01626, 22261, P30CA033572
- Status last verified
- Oct 2026
- First submitted
- 6 Mar 2023
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family HOPE Study (Hereditary Lynch Syndrome Opportunities for Participation &Amp; Engagement)
- ClinicalTrials.gov ID
- NCT05772130
- Acronym / sponsor ID
- 22261
- Conditions
- Hematopoietic and Lymphoid System Neoplasm, Hereditary Malignant Neoplasm, Malignant Solid Neoplasm
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 10 Mar 2023 (actual)
- Primary completion
- 21 Dec 2026 (estimated)
- Study completion
- 21 Dec 2026 (estimated)
- First posted
- 16 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial tests whether provider-mediated communication of genetic testing results to at-risk relatives of cancer patients can help improve genetic counseling and testing rates. Approximately 15% of people with cancer have an inherited form of cancer due to changes in a gene that they have inherited from one of their parents. These changes increase a person's risk for developing cancer. Most people who have an inherited harmful change in a cancer risk gene don't know that they have it and are therefore not able to get the health care that they need. The primary reason for this problem has been a lack of genetic counseling and testing for cancer patients and patients with a strong family history of cancer. Another reason for this lack of awareness is that, when cancer runs in a family, the patient who carries the gene change usually has to communicate the genetic risk information to their family members. When this process doesn't work well, family members may not know that they need to get genetic testing and then may not get potentially life-saving care. Provider-mediated contact to discuss genetic test results may help improve rates of genetic testing among at-risk relatives of patients with a family cancer syndrome.
Detailed description
PRIMARY OBJECTIVES:
- Improve rates of family member cascade testing. II. Evaluate the psychosocial impact of provider-mediated contact to communicate genetic testing results.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Patients receive a family letter and their genomic test report to share with at-risk first degree relatives on study.
ARM II: Patients receive a family letter and their genomic test report to share with at-risk first degree relatives and relatives also receive provider-mediated contact to discuss genetic results on study.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (usual care) | Active comparator | Other: Best Practice, Other: Electronic Health Record Review, Other: Survey AdministrationPatients receive a family letter and their genomic test report to share with at-risk first degree relatives on study. |
| Arm II (provider-mediated contact) | Experimental | Other: Electronic Health Record Review, Behavioral: Personal Contact, Other: Survey AdministrationPatients receive a family letter and their genomic test report to share with at-risk first degree relatives and relatives also receive provider-mediated contact to discuss genetic results on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- PATIENTS: Enrolled in City of Hope (COH) institutional review board (IRB) 07047 or have been seen by COH Genetics for genetic testing
- PATIENTS: Have an pathogenic/ likely pathogenic germline variant
- PATIENTS: Fluent in English
- PATIENTS: Age >= 18 years
- PATIENTS: Willing to provide contact information for eligible first-degree relatives
Key exclusion criteria (6 listed)
- PATIENTS: Unable to provide informed consent
- PATIENTS: =< 2 at-risk first-degree relatives who are eligible for genetic testing and/or reside within the United States
- PATIENTS: Unwilling to provide contact information for family members
- FIRST-DEGREE RELATIVES: Unable or unwilling to provide informed consent
- FIRST-DEGREE RELATIVES: Have undergone genetic testing for the known familial variant
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 family letter and genomic test report | Other | Arm I (usual care) |
| Electronic Health Record ReviewAncillary studies | Other | Arm I (usual care), Arm II (provider-mediated contact) |
| Personal ContactAlso: ContactReceive family letter and genomic test report with provider-mediated contact | Behavioural | Arm II (provider-mediated contact) |
| Survey AdministrationAncillary studies | Other | Arm I (usual care), Arm II (provider-mediated contact) |
Primary outcome
The percentage of uptake of cascade testing among patients' first-degree at-risk relatives
Time frame: Up to 9 months after enrollment
Will calculate descriptive statistics first, including the mean, median and standard deviation of the number of the first-degree and secondary-degree at-risk relatives. We will then compare the proportion of identified relatives who completed genetic testing between the intervention and the control arms with a one-sided Cochran-Mantel-Haenszel test. Type I error of 0.05 will be used and descriptive statistics will be calculated for all exploratory outcomes along with 95% confidence intervals. All statistical testing and calculation of confidence intervals will adjust for intra-proband correlation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
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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.
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, Electronic Health Record Review and Personal Contact in people with Hematopoietic and Lymphoid System Neoplasm and Hereditary Malignant Neoplasm, 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 12 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 16 Oct 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of uptake of cascade testing among patients' first-degree at-risk relatives (time frame: Up to 9 months after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Oct 2026.