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

June 12, 2026 updated by: National Cancer Institute (NCI)

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

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Study Description:

This study will explore the experience and management of screening related anxiety in Fanconi Anemia (FA) among participants in the Fanconi Anemia Cancer Screening Study (FACSS) protocol (NIH IRB #:001109). Knowledge generated from this study will improve understanding of the experience and management of cancer screening-related anxiety in the context of complex, rare disease, while providing much-needed information about the health experiences and challenges within the FA community.

Objectives:

To collect ethnographic observational field notes to explore the nature of cancer screening-related anxiety experienced by participants in the FACSS screening study at the NIH clinical center.

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • Recruiting
        • National Cancer Institute (NCI)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Examine screening-related anxiety usingethnographic field note
Time Frame: At Clinical Center Visit
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Sharon A Savage, M.D., National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 18, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

January 30, 2027

Study Registration Dates

First Submitted

December 19, 2024

First Submitted That Met QC Criteria

December 19, 2024

First Posted (Actual)

December 20, 2024

Study Record Updates

Last Update Posted (Actual)

June 15, 2026

Last Update Submitted That Met QC Criteria

June 12, 2026

Last Verified

March 19, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10002289
  • 002289-C

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Participants will not receive individual research results. Aggregate results of the research will be presented to the Fanconi Cancer Foundation (formerly Fanconi Anemia Research Fund) leadership and will be developed into a manuscript for publication.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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