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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2026-03287 | Other Identifier | NCI-CTRP Clinical Registry |
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To help people with high-risk cancer variants to follow cancer surveillance guidelines and lower their risk of developing the disease.
Primary Objective
1. The primary objective of this study is to assess feasibility of the intervention by achieving benchmarks, including:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Design and development | Experimental | This part of the study is a qualitative study that will include Qualitative Interviews with participants to help design a patient-centered digital application. |
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| Part 2: Feasibility study with two-arm randomization | Experimental | Patients will be randomized in a 1:1 ratio through REDCap to one of the two study arms described below. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard of care | Other | Standard of Care, no efforts will be made toward any of the study objectives |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety and adverse events (AEs). | Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 | Through study completion; an average of 1 year |
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Eligibility Criteria
Part 1 inclusion criteria:
Part 2 inclusion criteria:
Female participants.
With known deleterious/pathogenic mutation or likely pathogenic/deleterious variant in HBOC genes (BRCA1/2) or Lynch associated genes (MLH1, MSH2, MSH6, PMS2, EPCAM);
Age criteria met by pathogenic variants as listed below:
Speaks and reads English or Spanish.
Has access to a smartphone with operating system compatible with iOS/Android applications; and
Has not previously undergone bilateral salpingo-oophorectomy.
Exclusion Criteria
Part 1 exclusion criteria:
Part 2 exclusion criteria:
Females
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jose Rauh-Hain, MD | Contact | 713-794-1759 | jarauh@mdanderson.org |
| Name | Affiliation | Role |
|---|---|---|
| Jose Rauh-Hain, MD | 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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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| D007407 | Interviews as Topic |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Interviews | Other | Up to three interviews may be conducted per participant, and they may take place remotely via a secure videoconferencing service to limit disruptions to the participants schedule as well as any financial burden associated with travel. |
|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011634 | Public Health |
| D004778 | Environment and Public Health |