A web-based psychosocial support program for families with Li-Fraumeni Syndrome or Fanconi Anemia: A brief feasibility study protocol

A web-based psychosocial support program for families with Li-Fraumeni Syndrome or Fanconi Anemia: A brief feasibility study protocol - ReFLECT

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00040430

Enrollment

Registered

2026-05-22

Start date

2026-04-25

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Li-Fraumeni Syndrome, cancer predisposition, TP53 Fanconi Anemia Z80 C97 D61.0

Interventions

Group 1: The ReFLECT intervention combines four structured thematic online group sessions with supplementary psychoeducational materials and exercises delivered via a dedicated study website. Followin

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Adult individuals diagnosed with Li-Fraumeni syndrome (full Li-Fraumeni spectrum*) or Fanconi anaemia - Adult relatives and close significant others of affected individuals (e.g., partners, children, siblings, or other close family members/caregivers) - Native German speakers or individuals with good German language proficiency (at least B2 level) - Provision of written informed consent for study participation - Access to a stable internet connection at home and a digital device (e.g., computer or smartphone)

Exclusion criteria

Exclusion criteria: - Absence of a signed informed consent form - Insufficient German language skills (below B2 level) - Severe mental health conditions that would make participation in the study appear unfeasible (disorders classified under ICD-10 categories F0–F2)

Design outcomes

Primary

Measure	Time frame
Feasibility and acceptability of the intervention will be assessed based on recruitment rate, dropout rate, adherence to the intervention, and participants’ overall satisfaction with the program. Data feasibility and quality will be evaluated using indicators including recruitment rate, dropout rate, and completeness of the collected datasets. Participant satisfaction with the internet-based intervention will be measured using the Client Satisfaction Questionnaire for Internet-based Interventions (CSQ-I), an 8-item instrument assessing user satisfaction on a four-point Likert scale. Usability of the study website will be assessed using the System Usability Scale (SUS), a 10-item questionnaire evaluating perceived usability on a five-point Likert scale. In addition, after completion of each website module, participants will provide feedback regarding the module’s usefulness and comprehensibility.	—

Measure

Time frame

Feasibility and acceptability of the intervention will be assessed based on recruitment rate, dropout rate, adherence to the intervention, and participants’ overall satisfaction with the program. Data feasibility and quality will be evaluated using indicators including recruitment rate, dropout rate, and completeness of the collected datasets. Participant satisfaction with the internet-based intervention will be measured using the Client Satisfaction Questionnaire for Internet-based Interventions (CSQ-I), an 8-item instrument assessing user satisfaction on a four-point Likert scale. Usability of the study website will be assessed using the System Usability Scale (SUS), a 10-item questionnaire evaluating perceived usability on a five-point Likert scale. In addition, after completion of each website module, participants will provide feedback regarding the module’s usefulness and comprehensibility.

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Secondary

Measure	Time frame
Changes in secondary outcome variables from pre- to post-intervention will be assessed. The Social Support in Illness Scale (SSUK-8) is an 8-item questionnaire measuring perceived social support in the context of illness. It assesses both positive support and negative or burdensome interactions, with a completion time of approximately 2 minutes. The General Self-Efficacy Scale (SWE) consists of 10 items assessing individuals’ general perceived self-efficacy. The Patient Health Questionnaire (PHQ-9) measures the severity of depressive symptoms over the past two weeks using 9 items rated on a four-point Likert scale. The Generalized Anxiety Disorder Scale (GAD-7) assesses anxiety symptom severity over the past two weeks using 7 items rated on a four-point Likert scale. The EORTC Quality of Life Questionnaire – F17 (EORTC QLQ-F17) is a 17-item instrument assessing health-related quality of life across multiple functional domains (physical, role, emotional, cognitive, and social functioning) on a four-point Likert scale, and provides an overall score. The Fear of Progression Questionnaire – Short Form (PA-F-KF) assesses fear of disease progression using 12 items rated on a five-point Likert scale. It comprises four subscales (affective reactions, partnership/family, work, and loss of autonomy) (Mehnert et al., 2006). For close relatives, a modified partner version (PA-F-P-KF) is used, with item wording adapted accordingly (e.g., “I am afraid that my relative may be in pain” instead of “I am afraid that my partner may be in pain”). All versions consist of 12 items and are validated in German. The Short Version of the Family Assessment Device (KSAFF) is based on the McMaster Model of Family Functioning and is a widely used self-report instrument assessing family functioning. It comprises 51 items rated on a four-point Likert scale across six domains: problem solving, communication, roles, affective responsiveness, affective involvement, and behavioral contro	—

Measure

Time frame

Changes in secondary outcome variables from pre- to post-intervention will be assessed. The Social Support in Illness Scale (SSUK-8) is an 8-item questionnaire measuring perceived social support in the context of illness. It assesses both positive support and negative or burdensome interactions, with a completion time of approximately 2 minutes. The General Self-Efficacy Scale (SWE) consists of 10 items assessing individuals’ general perceived self-efficacy. The Patient Health Questionnaire (PHQ-9) measures the severity of depressive symptoms over the past two weeks using 9 items rated on a four-point Likert scale. The Generalized Anxiety Disorder Scale (GAD-7) assesses anxiety symptom severity over the past two weeks using 7 items rated on a four-point Likert scale. The EORTC Quality of Life Questionnaire – F17 (EORTC QLQ-F17) is a 17-item instrument assessing health-related quality of life across multiple functional domains (physical, role, emotional, cognitive, and social functioning) on a four-point Likert scale, and provides an overall score. The Fear of Progression Questionnaire – Short Form (PA-F-KF) assesses fear of disease progression using 12 items rated on a five-point Likert scale. It comprises four subscales (affective reactions, partnership/family, work, and loss of autonomy) (Mehnert et al., 2006). For close relatives, a modified partner version (PA-F-P-KF) is used, with item wording adapted accordingly (e.g., “I am afraid that my relative may be in pain” instead of “I am afraid that my partner may be in pain”). All versions consist of 12 items and are validated in German. The Short Version of the Family Assessment Device (KSAFF) is based on the McMaster Model of Family Functioning and is a widely used self-report instrument assessing family functioning. It comprises 51 items rated on a four-point Likert scale across six domains: problem solving, communication, roles, affective responsiveness, affective involvement, and behavioral contro

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Countries

Germany

Contacts

Public ContactImad Maatouk

Universitätsklinikum Würzburg

maatouk_i@ukw.de+49 931 201 40060

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 11, 2026