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| ID | Type | Description | Link |
|---|---|---|---|
| FP00015533 | Other Grant/Funding Number | Foundation for Women's Cancer | |
| NCI-2022-10573 | Other Identifier | NCI-CTRP Clinical Trials Registry |
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This is a community-based study requiring participant-self-enrollment, that can help to increase the rates of genetic testing among the family members of people who have been diagnosed with a hereditary cancer syndrome. The two main factors in this study are the IGNITE-TX intervention (website and navigator) and the free genetic counseling and testing.
The IGNITE-TX Intervention is an innovative multi-modal intervention, with two components: a) interactive web "IGNITE-TX Hub" and b) genetic family navigators.
Primary Objectives:
The primary objectives of this study are to assess the study feasibility by estimating:
Secondary Objectives:
The secondary objectives of this study are to:
Exploratory Objectives:
The exploratory objectives in this study are to estimate:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 (Standard of Care Group) | No Intervention | Participants (probands, those with a hereditary cancer syndrome) are sent a family letter to share with relatives. The letter contains information about hereditary cancer syndromes and encourages relatives to participate in the study and to get genetic testing. Relatives of probands randomized to the usual care arm will have access to the family letter if probands decide to share it with them, and will receive study surveys. The letter contains information about hereditary cancer syndromes and encourages relatives to participate in the study and to get genetic testing | |
| Group 2 (Free genetic testing and counseling group) | Experimental | Enrolled relatives will receive a letter and baseline survey with information to contact the tele-genetics company to arrange free genetic counseling and testing. This letter will be given to the relatives directly by the study |
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| Group 3 (IGNITE-TX Group) | Experimental | Relatives of probands randomized to the IGNITE-TX intervention will receive a family letter after enrollment and baseline survey with their personal access codes (not to be shared) to the IGNITE-TX "Hub" (access online educational material through a platform). Relatives will have also access services of a family genetic navigator. Study investigators and navigators will not directly provide genetic counseling and/or testing in this arm |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Free genetic testing and counseling group | Behavioral | Option to access no-cost telegenetic counseling and genetic testing |
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| Measure | Description | Time Frame |
|---|---|---|
| Measure enrollment of probands and at-risk relatives over a 6-month period | Up to 6 months | |
| Measure response rate to baseline and follow-up surveys by probands and at-risk relatives | Up to 6 months |
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Probands
Inclusion Criteria:
Exclusion Criteria:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jose Rauh-Hain, MD,MPH | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center | View source |
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| Group 4 (IGNITE-TX and free genetic testing and counseling group) |
| Experimental |
Relatives randomized to this arm will receive a family letter after enrollment and baseline survey with their personal access codes (not to be shared) to the IGNITE-TX "Hub" (access online educational material through a platform) and information to contact the tele genetics company. This arm will receive both the IGNITE-TX Intervention and access to free genetic testing and counseling services, as well as access to assistance from family genetic navigator |
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| IGNITE-TX Group | Behavioral | Access online educational materials through the IGNITE-TX platform and receive assistance from a family genetic navigator |
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| IGNITE-TX and free genetic testing and counseling group | Behavioral | Option to access no-cost telegenetic counseling and genetic testing, access to online educational materials through the IGNITE-TX platform, and assistance from a family genetic navigator |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D001943 | Breast Neoplasms |
| D003123 | Colorectal Neoplasms, Hereditary Nonpolyposis |
| D061325 | Hereditary Breast and Ovarian Cancer Syndrome |
| D003110 | Colonic Neoplasms |
| D016889 | Endometrial Neoplasms |
| D014594 | Uterine Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D009386 | Neoplastic Syndromes, Hereditary |
| 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 |
| D014591 | Uterine Diseases |
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