Experience and Management of Cancer Screening-Related Anxiety in Fanconi Anemia

NCT06744283 | Recruiting

• 2 other identifiers: 10002289002289-C
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

Uncertainty; Fanconi Anemia; Cancer; Screening

Outcome Measures

Primary Outcomes (1)

• Examine screening-related anxiety usingethnographic field note

  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.

  At Clinical Center Visit

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study team will conduct a concurrent mixed methods study involving ethnographic data collected from field notes of clinical visits for participants in the Fanconi Anemia Cancer Screening Study (FACSS) protocol (NIH IRB #: 001109), including initial intake and/or return of results.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Cancer Institute (NCI)

Bethesda, Maryland, 20892, United States

RECRUITING

MeSH Terms

Conditions

Fanconi Anemia; Neoplasms

Condition Hierarchy (Ancestors)

Anemia, Hypoplastic, Congenital; Anemia, Aplastic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Congenital Bone Marrow Failure Syndromes; Bone Marrow Failure Disorders; Bone Marrow Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; DNA Repair-Deficiency Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Sharon A Savage, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emily E Pearce

CONTACT

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

Sharon A Savage, M.D.

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2024
• First Posted: December 20, 2024
• Study Start (Estimated): May 11, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): January 30, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-03-19

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)