Fanconi AnemiaNCT06744283
Experience and Management of Cancer Screening-Related Anxiety in Fanconi Anemia
An observational study of Fanconi Anemia, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Fanconi Anemia
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2024to 1 Feb 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Fanconi Anemia
- Keywords
- Uncertainty, Fanconi Anemia, Cancer, Screening
- Medical subject headings
- Fanconi Anemia, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At Clinical Center Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start5 Dec 2024
- Primary completion1 Jan 2030 (estimated)
- Study completion1 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fanconi AnemiaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Sharon A Savage, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06744283
- Sponsor's protocol ID
- 10002289
- Other IDs
- 002289-C
- Status last verified
- 23 Sep 2026
- First submitted
- 19 Dec 2024
- Last updated
- 2 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Experience and Management of Cancer Screening-Related Anxiety in Fanconi Anemia: an Ethnographic Study
- ClinicalTrials.gov ID
- NCT06744283
- Acronym / sponsor ID
- 10002289
- Conditions
- Fanconi Anemia
- Keywords
- Uncertainty, Fanconi Anemia, Cancer, Screening
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 5 Dec 2024 (actual)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 1 Feb 2030 (estimated)
- First posted
- 20 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sharon A Savage, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fanconi Anemia, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Examine screening-related anxiety usingethnographic field note (time frame: At Clinical Center Visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.