Cascade TestingNCT07106359
Initial Testing of a Behavioral Intervention About Genetic Services for Families at Risk of Lynch Syndrome
A study testing Information Letter and Booklet and Information Letter in people with Cascade Testing and Lynch Syndrome, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The purpose of the study is to see if our education materials help people at risk for Lynch syndrome decide about seeking genetic services. Untested relatives of patients with Lynch syndrome will be recruited to complete a baseline survey and will be randomized to receive either the an information letter or an… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cascade Testing, Lynch Syndrome, Decision Making
- What is being tested?
- Information Letter and Booklet and Information Letter
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 185 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2025to 31 Oct 2027
- 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
Probands Inclusion Criteria:
- English speaking
- at least 18 years old
- have had genetic testing for Lynch syndrome (LS)
- do not have a condition that would interfere with their ability to provide informed consent and complete study activities (e.g., cognitive dysfunction evaluated using clinical judgment during screening)
Clinical Trial Participants Inclusion Criteria:
- English-speaking
- at least 18 years old
- a blood relative of a patient who was diagnosed with LS
- potentially at risk for LS
- have not scheduled or had pre-test genetic counseling or genetic testing for LS
- do not have a personal history of a cancer (excluding non-melanoma skin cancer)
- do not have a condition that would interfere with their ability to provide informed consent and complete study activities (e.g., cognitive dysfunction evaluated using clinical judgment during screening)
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
UAB
Birmingham, Alabama, 35233
study team, 205-914-2249, LSPilotStudy@uabmc.edu
About this study
Official title: A Randomized Controlled Pilot Trial of a Behavioral Intervention to Increase Uptake of Genetic Services Among Relatives at Risk of Lynch Syndrome
The purpose of the study is to see if our education materials help people at risk for Lynch syndrome decide about seeking genetic services. Untested relatives of patients with Lynch syndrome will be recruited to complete a baseline survey and will be randomized to receive either the an information letter or an information letter plus a booklet. Two follow-up surveys will be administered over the span of 6 months. Participants will also be invited to join an optional exit interview to provide feedback.
Read the detailed description
Lynch syndrome runs in families. It increases the risk of many types of cancer. Pre-test genetic counseling is an opportunity for at-risk people to determine whether genetic testing is right for them. Genetic testing looks for harmful changes in the genes known to cause Lynch syndrome. However, Lynch syndrome is underdiagnosed and uptake of genetic counseling and testing is low, missing opportunities for cancer prevention and early treatment.
This study is a 2-arm randomized controlled pilot trial. We aim to recruit 48 relatives at risk of LS (from about 137 probands) and randomize them to receive either the an information letter or an information letter plus a booklet. Only one relative will be enrolled per family. The primary aim of this pilot trial is to evaluate and optimize feasibility of the trial methods and the education materials to prepare for a fully powered randomized controlled trial. A brief exit interview will be conducted at 6-months post-randomization to gather any feedback about the study methods. Reasons of those who refuse to participate or drop out of the study will be assessed throughout the study.
- Conditions
- Cascade Testing, Lynch Syndrome, Decision Making, Colorectal Cancer, Uterine Cancer, Cancer Prevention
- Being tested
- Information Letter and Booklet, Information Letter
- Medical subject headings
- Colorectal Neoplasms, Hereditary Nonpolyposis, Colorectal Neoplasms, Uterine Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Information Letter and BookletBehavioural
an information letter with a booklet for at-risk families highlighting implications of family history, testing considerations, steps for genetic testing, and potential costs.
Information LetterBehavioural
an information letter with basic information about LS and implications of counseling and testing of LS, and a few websites for more information and locating genetic counselors.
| Study group | Role | What they receive |
|---|---|---|
| Information Letter | Active comparator | This arm provides an information letter about Lynch syndrome and genetic services. Receives: Behavioral: Information Letter |
| Information Letter and Booklet | Experimental | This arm provides an information letter with a booklet about Lynch syndrome and genetic services. Receives: Behavioral: Information Letter and Booklet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility (recruitment and retention rates, completeness of assessment data)
Record the numbers of probands approached, probands enrolled, probands who provide contact information of at least one potentially eligible relative, relatives approached, enrolled, and completing each phase of the study.
Calculate the percentage of complete data for those participants who complete each assessment period.
Measured: (recruitment) baseline, 1-month and 6-months post-randomization
Use and attitudes towards the education materials
Assess the extent to which participants reviewed the information letter and booklet and their attitudes, likelihood of sharing the materials, feedback on the materials and impact on decisions, how the information should be delivered.
Measured: 1-month post-randomization (may also include in 6-month post-randomization
Scheduling and attendance of pre-test genetic counseling and/or genetic testing
Record whether participants scheduled or attended pre-test genetic counseling and genetic testing to calculate the proportion of genetic services uptake.
Measured: 6-months post-randomization
Secondary outcomes (1)
Scheduling and attendance of pre-test genetic counseling and/or genetic testing
Record whether participants scheduled or attended pre-test genetic counseling and genetic testing to calculate the proportion of genetic services uptake.
Measured: 1-month post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start15 Sep 2025
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cascade TestingStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 185 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Haoyang Yan, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07106359
- Sponsor's protocol ID
- IRB-300014784
- Other IDs
- R00CA277584
- Status last verified
- Jul 2026
- First submitted
- 30 Jul 2025
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Pilot Trial of a Behavioral Intervention to Increase Uptake of Genetic Services Among Relatives at Risk of Lynch Syndrome
- ClinicalTrials.gov ID
- NCT07106359
- Acronym / sponsor ID
- IRB-300014784
- Conditions
- Cascade Testing, Lynch Syndrome, Decision Making, Colorectal Cancer, Uterine Cancer, Cancer Prevention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 185 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 6 Aug 2025 (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.
The purpose of the study is to see if our education materials help people at risk for Lynch syndrome decide about seeking genetic services. Untested relatives of patients with Lynch syndrome will be recruited to complete a baseline survey and will be randomized to receive either the an information letter or an information letter plus a booklet. Two follow-up surveys will be administered over the span of 6 months. Participants will also be invited to join an optional exit interview to provide feedback.
Detailed description
Lynch syndrome runs in families. It increases the risk of many types of cancer. Pre-test genetic counseling is an opportunity for at-risk people to determine whether genetic testing is right for them. Genetic testing looks for harmful changes in the genes known to cause Lynch syndrome. However, Lynch syndrome is underdiagnosed and uptake of genetic counseling and testing is low, missing opportunities for cancer prevention and early treatment.
This study is a 2-arm randomized controlled pilot trial. We aim to recruit 48 relatives at risk of LS (from about 137 probands) and randomize them to receive either the an information letter or an information letter plus a booklet. Only one relative will be enrolled per family. The primary aim of this pilot trial is to evaluate and optimize feasibility of the trial methods and the education materials to prepare for a fully powered randomized controlled trial. A brief exit interview will be conducted at 6-months post-randomization to gather any feedback about the study methods. Reasons of those who refuse to participate or drop out of the study will be assessed throughout the study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Information Letter | Active comparator | Behavioral: Information LetterThis arm provides an information letter about Lynch syndrome and genetic services. |
| Information Letter and Booklet | Experimental | Behavioral: Information Letter and BookletThis arm provides an information letter with a booklet about Lynch syndrome and genetic services. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Information Letter and Bookletan information letter with a booklet for at-risk families highlighting implications of family history, testing considerations, steps for genetic testing, and potential costs. | Behavioural | Information Letter and Booklet |
| Information Letteran information letter with basic information about LS and implications of counseling and testing of LS, and a few websites for more information and locating genetic counselors. | Behavioural | Information Letter |
Primary outcome
Feasibility (recruitment and retention rates, completeness of assessment data)
Time frame: (recruitment) baseline, 1-month and 6-months post-randomization
Record the numbers of probands approached, probands enrolled, probands who provide contact information of at least one potentially eligible relative, relatives approached, enrolled, and completing each phase of the study. Calculate the percentage of complete data for those participants who complete each assessment period.
Use and attitudes towards the education materials
Time frame: 1-month post-randomization (may also include in 6-month post-randomization
Assess the extent to which participants reviewed the information letter and booklet and their attitudes, likelihood of sharing the materials, feedback on the materials and impact on decisions, how the information should be delivered.
Scheduling and attendance of pre-test genetic counseling and/or genetic testing
Time frame: 6-months post-randomization
Record whether participants scheduled or attended pre-test genetic counseling and genetic testing to calculate the proportion of genetic services uptake.
1 secondary outcome
Scheduling and attendance of pre-test genetic counseling and/or genetic testing
Time frame: 1-month post-randomization
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 21 Jul 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Information Letter and Booklet and Information Letter in people with Cascade Testing and Lynch Syndrome, run by University of Alabama at Birmingham 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?
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 21 Jul 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?
Contact Haoyang Yan, PhD (205-914-2249, LSPilotStudy@uabmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (recruitment and retention rates, completeness of assessment data) (time frame: (recruitment) baseline, 1-month and 6-months post-randomization). The study lists 3 primary outcomes in all. 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 21 Jul 2026.