연구제목

The Experience and Management of Cancer Screening-Related Anxiety in Fanconi Anemia: an Ethnographic Study

연구요약

Background: Fanconi anemia (FA) is a rare, inherited cancer syndrome. FA causes a range of physical issues. Children with FA may have abnormal features; these may include a small head and eyes and issues with their internal organs. Young adults have a much higher risk of cancer. To screen for these cancers, people with FA may need to pursue many visits with different doctors. This constant need for cancer screening may cause anxiety for people with FA. Objective: To learn more about anxiety related to cancer screenings in people with FA. Eligibility: Adults aged 18 years and older with FA. They must also be enrolled in FACSS. FACSS is a study that screens people with FA for cancer every year. Design: All data gathered for this study will occur during routine FACSS visits. No other visits are needed. An observer will be in the room during participants FACSS visits. The observer and participant will have a polite introduction. After that, the observer will not interact with participants in any way. The observer will note details about the participants, such as: * Body language. * Worries about screening. * Comments that suggest anxiety or depression. * Clinical environment, such as d(SqrRoot)(Copyright)cor and temperature. * Accessibility issues. These can include lights and noises as well as ease of traveling around the clinic center. * Evidence of social support, such as engaging in the FA community. * Challenges they ve had in FACSS. * Their motivation to participate in FACSS. * Relationship dynamics among clinic staff, participants, and their care partners. Data will also be collected from FACSS visit notes dating back to December 2024 and from participants medical records.

연구의뢰자

National Cancer Institute (NCI)

연구모집현황

RECRUITING

임상시험의 목적

ClinicalTrials.gov 등록번호

NCT06744283

추가 연구 번호

최신갱신일

2025-06-11

연구종료일

2026-01-30

연구 버전 기록

실시기관명

facility: National Cancer Institute (NCI)
status: RECRUITING
city: Bethesda
state: Maryland
zip: 20892
country: United States
contacts: [{name=Emily Pearce, M.P.H., role=CONTACT, phone=240-276-7254, email=emily.pearce@nih.gov}]
geoPoint: {lat=38.98067, lon=-77.10026}

연구대상 상태/질환

Fanconi Anemia

대상질환

id: M4070
name: Anemia
asFound: Anemia
relevance: HIGH

id: M4324
name: Anxiety Disorders
relevance: LOW

id: M8341
name: Fanconi Syndrome
asFound: Fanconi Anemia
relevance: HIGH

id: M8342
name: Fanconi Anemia
asFound: Fanconi Anemia
relevance: HIGH

id: M16355
name: Syndrome
relevance: LOW

id: M9490
name: Hematologic Diseases
relevance: LOW

id: M23455
name: Anemia, Hypoplastic, Congenital
relevance: LOW

id: M4071
name: Anemia, Aplastic
relevance: LOW

id: M2241
name: Bone Marrow Failure Disorders
relevance: LOW

id: M13118
name: Pancytopenia
relevance: LOW

id: M2242
name: Congenital Bone Marrow Failure Syndromes
relevance: LOW

id: M5134
name: Bone Marrow Diseases
relevance: LOW

id: M23686
name: Genetic Diseases, Inborn
relevance: LOW

id: M26131
name: DNA Repair-Deficiency Disorders
relevance: LOW

id: M11639
name: Metabolic Diseases
relevance: LOW

id: M18151
name: Renal Tubular Transport, Inborn Errors
relevance: LOW

id: M10698
name: Kidney Diseases
relevance: LOW

id: M17319
name: Urologic Diseases
relevance: LOW

id: M2875
name: Urogenital Diseases
relevance: LOW

id: M27093
name: Female Urogenital Diseases
relevance: LOW

id: M14127
name: Pregnancy Complications
relevance: LOW

id: M8399
name: Female Urogenital Diseases and Pregnancy Complications
relevance: LOW

id: M27095
name: Male Urogenital Diseases
relevance: LOW

id: T2270
name: Fanconi Anemia
asFound: Fanconi Anemia
relevance: HIGH

id: T1464
name: Congenital Aplastic Anemia
asFound: Fanconi Anemia
relevance: HIGH

id: T2272
name: Fanconi Syndrome
asFound: Fanconi Anemia
relevance: HIGH

제품명(코드명)

활성대조약 여부

대조약 여부

위약 여부

대조약

-

중재/치료

중재 방법

연구종류

OBSERVATIONAL

임상시험단계

배정

중재모형

눈가림대상자

중재군명

중재군 유형

label: Participants with a diagnosis of Fanconi anemia
description: Participants enrolled in the Fanconi Anemia Cancer Screening Study (FACSS) protocol (NIH IRB #: 001109) who are 18 years of age or older are eligible for inclusion in this study.

중재군 수

0

중재군 별 설명 및 등록 환자수

중재군 목표대상자 수

0

기관소재지

실시기관 전화번호

연구참여기관

국가

환자모집국가

최초 연구대상자 등록일

2025-06-16

상세내용

대상자 선정 및 제외기준

* INCLUSION CRITERIA: Participants enrolled in the FACSS protocol who are 18 years of age or older are eligible for inclusion in this study. Clinical visits eligible for ethnographic observation are limited to initial visits (medical history and physical examination) and/or return of results visits happening in the context of their first visit to the NIH Clinical Center for the FACSS protocol and/or annual return visits. To be eligible, the following requirements must be met: * Ability for the participant to speak, read, and/or write in English to understand and agree to a verbal consent. * Participants must have a diagnosis of FA. * Participants must be 18 years of age or older. EXCLUSION CRITERIA: * Individuals who do not meet eligibility criteria. * Subjects who declined or opted out of allowing their data to be used for future research. * Subjects who orally declined to have Dr. Emily Pearce shadow their clinical center visits. * No other exclusionary criteria apply.

참여 가능한 연령 하한

18 Years

참여 가능한 연령 상한

100 Years

참여 가능한 표준 연령

ADULT

OLDER_ADULT

대상자 포함기준 성별

ALL

건강인 참여 여부

NO

실제 대상자수

20

기존 목표대상자 수(실제)

0

최종 연구대상자 수

0

최종 시험대상자 선정일

시험대상자 > 분석대상군

시험대상자 > 인구학적 정보

주요결과변수

measure: Examine screening-related anxiety usingethnographic field note
description: This mixed methods study will examine screening-related anxiety using ethnographic field notes include: 1) content analysis of predetermined categories of observation, and 2) qualitative analysis of field notes describing patient provider communication.
timeFrame: At Clinical Center Visit

보조결과변수

주요 평가 > 1차 평가변수 결과

최종 주평가변수 수집 완료일

2026-01-30

임상시험결과요약

연구책임자 전화번호

연구책임자 주소

연구실무담당자 성명

연구실무담당자 직위

연구실무담당자 전화번호

name: Emily E Pearce
role: CONTACT
phone: (240) 276-7254
email: emily.pearce@nih.gov

name: Sharon A Savage, M.D.
role: CONTACT
phone: (240) 276-7241
email: savagesh@mail.nih.gov

연구실무담당자 기관명