Official Title

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

Brief Summary

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.

Sponsor

National Cancer Institute (NCI)

Recruitment Status

RECRUITING

Study Objective

ClinicalTrials.gov ID

NCT06744283

Additional Identification number

Last Update Posted

2025-06-11

Study Completion (Actual)

2026-01-30

Study Record Versions

Contacts and Locations

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}

Conditions

Fanconi Anemia

TargetDisease

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

ProductName

IsActiveControl

IsControlDrug

IsPlacebo

ControlDrug

-

Intervention / Treatment

Intervention

Study Type

OBSERVATIONAL

Phase

Allocation

Interventional Model

Subject Blind

Arm Label

Arm Type

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.

NumberOfInterventionGroups

0

GroupEnrollment

Target Number of Participant

0

InstitutionLocation

InstitutionPhoneNumber

Study Site

Location Countries

Countries of recruitment

Study Start (Actual)

2025-06-16

Arm Description

Inclusion and Exclusion Criteria

* 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.

minimum age

18 Years

maximum age

100 Years

Standard ages

ADULT

OLDER_ADULT

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

NO

Enrollment (Actual)

20

Original Enrollment (Actual)

0

Final Enrollment Number

0

FinalSubjectSelectionDate

AnalysisTargetGroup

DemographicInformation

Primary Outcome Measures

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

Secondary Outcome Measures

PrimaryEndpointResult

Primary Completion Date (Actual)

2026-01-30

ClinicalTrialResultSummary

Telephone

Address

Name

Title

Telephone

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

Affiliation