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| ID | Type | Description | Link |
|---|---|---|---|
| U01CA254832 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| University of South Florida | OTHER |
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The IMPACT Study seeks to refine and evaluate the effectiveness of interventions on improving guideline-adherent cancer risk management (CRM) and family communication (FC) of genetic test results for individuals with a documented pathogenic/likely pathogenic (P/LP) variant, and FC of family cancer history for individuals with a variant of uncertain significance (VUS) in an inherited cancer gene.
Through recruitment of a racially, geographically, and socioeconomically diverse sample of patients, we will achieve the following aims:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GeneSHARE | Experimental | Access to GeneSHARE, a web-based toolkit including interactive and narrative components to enhance FC of genetic test results. |
|
| LivingLabReport | Experimental | Access to LivingLabReport, a website containing multiple resources including a summary of the patient's genetic test results, condition-specific information, recommended CRM, and information on accessing CRM services. |
|
| Standard-of-care | Active Comparator | Receive standard-of-care from their treating healthcare provider. |
|
| Variants of Uncertain Significance (VUS) Pilot Study | Experimental | Participants are provided access to VUS educational resources including video and written education and assistance for speaking with family members. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Correlative Studies (Survey) | Other | Administer surveys |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in FC of genetic test results (if P/LP variant result) or family history of cancer (if VUS result) | Having at least one additional at-risk adult, living relative with whom the participant has shared their test result, information about testing, or family history of cancer for the first time or has subsequently followed up with a relative | 12 months |
| Change in CRM | Ongoing guideline-adherent CRM or a change towards guideline-adherent CRM per National Comprehensive Cancer Network (NCCN) CRM guidelines based on genetic test results as measured by survey data and verified through medical records where possible and/or appropriate. | 12 months |
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Randomized Controlled Trial Eligibility: All trial participants will be autonomous adults who are capable of participating in the study
Inclusion Criteria:
English-speaking men and women aged 18 years or older
Not adopted (i.e., have information about their biological relatives)
Have access to internet and a computer, tablet, or smartphone
Documented pathogenic/likely pathogenic variant in an inherited cancer gene that has CRM guidelines listed in the National Comprehensive Cancer Network (NCCN) Genetic/Familial Panel focused on Breast, Ovarian, and Pancreatic or Colorectal cancers
Must meet at least one of the following criteria:
Intervention A (GeneSHARE) criteria: Have at least one at-risk adult, living relative who either:
Intervention B (LivingLabReport) criteria: Are non-adherent (i.e., either undertreatment or overtreatment) to at least one of the current NCCN CRM guidelines or if currently adherent, require ongoing cancer screening
VUS Pilot Study Eligibility: All VUS pilot study participants will be autonomous adults who are capable of participating in the study. Eligibility criteria include:
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| Name | Affiliation | Role |
|---|---|---|
| Tuya Pal, MD | Vanderbilt-Ingram Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | 37212 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34645413 | Derived | Cragun D, Beckstead J, Farmer M, Hooker G, Dean M, Matloff E, Reid S, Tezak A, Weidner A, Whisenant JG, Pal T. IMProving care After inherited Cancer Testing (IMPACT) study: protocol of a randomized trial evaluating the efficacy of two interventions designed to improve cancer risk management and family communication of genetic test results. BMC Cancer. 2021 Oct 13;21(1):1099. doi: 10.1186/s12885-021-08822-4. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Aug 11, 2023 | Aug 30, 2023 |
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| Correlative Studies (Interview) | Other | In-depth interviews among a subset of participants after the 12-month follow-up survey to either: 1) determine additional resources and tailored message that would be helpful; or 2) assess the adaptive intervention |
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| GeneSHARE | Behavioral | Access to GeneSHARE, a web-based toolkit which includes interactive and narrative components to enhance FC of genetic test results. |
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| LivingLabReport | Behavioral | Access to LivingLabReport, a website containing multiple resources including a summary of the patient's genetic test results, condition-specific information, recommended CRM, and information on accessing CRM services. |
|
| Standard-of-care & Adaptive Intervention | Behavioral | Receive standard-of-care from their treating healthcare provider. A subset of individuals will also be asked to test and pilot the adaptive intervention, which will consist of tailored resources to promote CRM and FC, after the 12-month follow-up survey. |
|
| Access to Education Materials | Other | Receive access to VUS educational materials |
|
| ICF_001.pdf |
| ID | Term |
|---|---|
| D009386 | Neoplastic Syndromes, Hereditary |
| D011471 | Prostatic Neoplasms |
| D015179 | Colorectal Neoplasms |
| D016889 | Endometrial Neoplasms |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| D007407 | Interviews as Topic |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D019984 | Quality Indicators, Health Care |
| D006298 | Health Services Administration |
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