Recruiting

Observational Study

Sponsor:

National Cancer Institute (NCI)

Code:

NCT06744283

Conditions

Fanconi Anemia

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Fanconi Anemia

Study ID

NCT06744283

Start date

Sep 1, 2026

Status verified date

Jul 7, 2026

Completion date

Jan 30, 2027

Anticipated

Primary completion date

Sep 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

  • 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.

Study Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Arms

Participants with a diagnosis of Fanconi anemia

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.

Primary outcome measure

  • Examine screening-related anxiety usingethnographic field note [ Time Frame: At Clinical Center Visit ]

Central Contacts and Locations

Central contacts

Emily E Pearce

(240) 276-7254emily.pearce@nih.gov

Sharon A Savage, M.D.

(240) 276-7241savagesh@mail.nih.gov

Locations

National Cancer Institute (NCI)

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

Emily Pearce, M.P.H.

240-276-7254emily.pearce@nih.gov

More Information

Sponsor

National Cancer Institute (NCI)

Last update posted

Aug 27, 2026

Last verified

Jul 7, 2026

Keywords

  • Uncertainty
  • Fanconi Anemia
  • Cancer
  • Screening

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Cancer Institute (NCI) on 2026-08-27.