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Initial Testing of a Behavioral Intervention About Genetic Services for Families at Risk of Lynch Syndrome

A Randomized Controlled Pilot Trial of a Behavioral Intervention to Increase Uptake of Genetic Services Among Relatives at Risk of Lynch Syndrome

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires, Interviews

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "A brief exit interview will be conducted at 6-months post-randomization to gather any feedback about the study methods."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether a letter alone or a letter plus a booklet helps people at risk for Lynch syndrome decide about genetic services, such as gene testing and advice. It is for adult blood relatives of people with Lynch syndrome who have not had testing for it. Participants will complete surveys over 6 months and may choose to do a final interview.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Everyone must speak English.
  • Everyone must be at least 18 years old.
  • Everyone must be able to understand and agree to join the study and complete study tasks.
  • Family members joining as the original patient must have had genetic testing for Lynch syndrome.
  • Relatives joining the trial must be blood relatives of someone diagnosed with Lynch syndrome and may be at risk for it.
  • Relatives must not have scheduled or received genetic testing or counseling before testing for Lynch syndrome.
  • Relatives must not have had cancer, except for non-melanoma skin cancer.

Who can't join

    Simplified for readability. The official criteria below are what the study team uses.

    Official eligibility criteria

    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)

    Study sites (1)

    AL