Pilot and evaluate the feasibility of an online intervention for LFS sufferers

Pilot and evaluate the feasibility of an online intervention for LFS sufferers - OnLiFe

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00030724

Enrollment

Registered

2023-06-09

Start date

2023-07-03

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

No ICD diagnoses available

Interventions

Group 1: Single-arm study of 20 healthy subjects in pre-post examination to test the feasibility of online intervention. For the evaluation of the intervention, qualitative and quantitative data will

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Diagnosis Li-Fraumeni syndrome, (probably) pathogenic TP53 germline variant. - Minimum age: 18 years - German as native language or very good knowledge of German - Informed written consent to participate in the study is required. - Safe handling and unrestricted access to laptop, PC, smartphone or tablet

Exclusion criteria

Exclusion criteria: - Unclassified variant in the TP53 gene (VUS) - Under current treatment for cancer (e.g. immunotherapy, chemotherapy, radiation) - Lack of signed informed consent - Lack of capacity to give consent - Insufficient knowledge of German - Insufficient technical equipment or ability - Limited legal capacity or similar impairments - Physical or mental impairment that makes it impossible to answer questionnaires or independently conduct an online intervention

Design outcomes

Primary

Measure	Time frame
The survey ends with the completion of t2 with 20 participants. Individuals who did not participate or only partially participated in the intervention should also participate in the final survey if possible and accessible. (1) Is the online intervention reliably feasible with the available technical and human resources? ? Participants complete the survey and online intervention up to 50%. ? Participants rate the criteria in the qualitative survey (e.g., time required, integrability) predominantly positively. (2) Does the online intervention meet the needs of the target group? ? The online intervention meets the needs of the participants if 1) the t2 results of the quantitative survey record a reduction in stress or increase in well-being, 2) the evaluation of the intervention evaluation is on average = 3, and 3) the feedback in the qualitative survey at t2 is predominantly positive. (3) To what extent do participants adopt and actively participate in the online intervention? How high is the adherence of the participants with regard to processing the modules? ? Participants complete at least 70% of the online intervention. (4) Is the questionnaire sufficiently answerable by the participants? ? Participants answer at least 70% of the qualitative and quantitative survey. Each question can be answered YES or NO. "Definitely well feasible" is the study if the proportion of YES answers is =90% and "definitely poorly feasible" if the proportion of YES answers is =50%.	—

Measure

Time frame

The survey ends with the completion of t2 with 20 participants. Individuals who did not participate or only partially participated in the intervention should also participate in the final survey if possible and accessible. (1) Is the online intervention reliably feasible with the available technical and human resources? ? Participants complete the survey and online intervention up to 50%. ? Participants rate the criteria in the qualitative survey (e.g., time required, integrability) predominantly positively. (2) Does the online intervention meet the needs of the target group? ? The online intervention meets the needs of the participants if 1) the t2 results of the quantitative survey record a reduction in stress or increase in well-being, 2) the evaluation of the intervention evaluation is on average = 3, and 3) the feedback in the qualitative survey at t2 is predominantly positive. (3) To what extent do participants adopt and actively participate in the online intervention? How high is the adherence of the participants with regard to processing the modules? ? Participants complete at least 70% of the online intervention. (4) Is the questionnaire sufficiently answerable by the participants? ? Participants answer at least 70% of the qualitative and quantitative survey. Each question can be answered YES or NO. "Definitely well feasible" is the study if the proportion of YES answers is =90% and "definitely poorly feasible" if the proportion of YES answers is =50%.

—

Secondary

Measure	Time frame
At least 20 participants completed the online intervention.	—

Countries

Germany

Contacts

Public ContactMadeleine Helaß

Universitätsklinikum Würzburg

helass_m@ukw.de+49 931 201 40060

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026