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| ID | Type | Description | Link |
|---|---|---|---|
| R00CA277584 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Information Letter | Active Comparator | This arm provides an information letter about Lynch syndrome and genetic services. |
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| Information Letter and Booklet | Experimental | This arm provides an information letter with a booklet about Lynch syndrome and genetic services. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Information Letter and Booklet | Behavioral | an information letter with a booklet for at-risk families highlighting implications of family history, testing considerations, steps for genetic testing, and potential costs. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | (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. | 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. | 6-months post-randomization |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1-month post-randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Psychosocial outcomes | perceived risk, stress, fear, and coping of LS, cancer worry, colonoscopy experience, family communication, decision conflict, factors influencing decisions, self-efficacy, information received, experience and perception of facilitators and barriers of seeking genetic services for LS, perceived stress, knowledge about LS and genetic services | baseline, 1-month post-randomization, 6-month post-randomization |
Probands Inclusion Criteria:
Clinical Trial Participants Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAB | Birmingham | Alabama | 35233 | United States |
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| Information Letter | Behavioral | 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. |
|
| ID | Term |
|---|---|
| D003123 | Colorectal Neoplasms, Hereditary Nonpolyposis |
| D015179 | Colorectal Neoplasms |
| D014594 | Uterine Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009386 | Neoplastic Syndromes, Hereditary |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D049914 | DNA Repair-Deficiency Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D012002 | Rectal Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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