iSCREEN – interventional study evaluating a digital questionnaire regarding familial breast and ovarian cancer burden

iSCREEN – interventional study evaluating a digital questionnaire regarding familial breast and ovarian cancer burden - îSCREEN

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00030585

Enrollment

240

Registered

2022-10-26

Start date

2022-11-01

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

Z80.3 Z80.4

Interventions

Group 1: The study participation per subject takes place in a single time of measurement during the waiting period for their appointment in the clinic. 1) First, sociodemographic data and the baselin

Eligibility

Sex/Gender

Female

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Biologically female patients of the outpatient clinic of the Department of Gynecology with Breast Center at the Charité Berlin who are between the ages of 18 and 70 can take part in the study.

Exclusion criteria

Exclusion criteria: Biologically male sex and declining to participate

Design outcomes

Primary

Measure	Time frame
An end point of the study is the concordance of the results of the digital questionnaire iSCREEN and those of the DKG-checklist. For this purpose, the presence of a familial cancer burden is assessed using the digital (iSCREEN) and the oral questionnaire (based on the DKG-checklist). In the event of discrepancies, these are further analyzed qualitatively in order to identify problems of understanding, difficult questions, etc. In order to evaluate the digital questionnaire's usability, the following parameters are collected: completion rate, number of answered questions, number of uncertainly answered questions including the specific question(s), time needed, understandability of iSCREEN (based on a 5-likert item), confidence while completing iSCREEN (using a 5 Likert item), preferred assessment method (digital vs. oral)* and sociodemographic parameters* as influencing factors. To investigate a possible psychological influence of the digital iSCREEN-questionnaire, the subjective breast and ovarian cancer risk perception* as well as the cancer worry* of such a disease is stated by study subjects before and after completion. All outcomes marked with * are collected using questionnaires other than the digital iSCREEN-questionnaire. All questionnaires have been reviewed and approved by a psychologist as well as the Charité ethics committee. As described above, per participant the entire study takes place once during their waiting period for the subsequent appointment in the gynecological outpatient clinic.	—

Measure

Time frame

An end point of the study is the concordance of the results of the digital questionnaire iSCREEN and those of the DKG-checklist. For this purpose, the presence of a familial cancer burden is assessed using the digital (iSCREEN) and the oral questionnaire (based on the DKG-checklist). In the event of discrepancies, these are further analyzed qualitatively in order to identify problems of understanding, difficult questions, etc. In order to evaluate the digital questionnaire's usability, the following parameters are collected: completion rate, number of answered questions, number of uncertainly answered questions including the specific question(s), time needed, understandability of iSCREEN (based on a 5-likert item)*, confidence while completing iSCREEN (using a 5 Likert item)*, preferred assessment method (digital vs. oral)* and sociodemographic parameters* as influencing factors. To investigate a possible psychological influence of the digital iSCREEN-questionnaire, the subjective breast and ovarian cancer risk perception* as well as the cancer worry* of such a disease is stated by study subjects before and after completion. All outcomes marked with * are collected using questionnaires other than the digital iSCREEN-questionnaire. All questionnaires have been reviewed and approved by a psychologist as well as the Charité ethics committee. As described above, per participant the entire study takes place once during their waiting period for the subsequent appointment in the gynecological outpatient clinic.

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Secondary

Measure	Time frame
The examined endpoints are described under "Primary Outcome“. Since this is an exploratory study, the separation into primary and secondary outcome is statistically not possible.	—

Countries

Germany

Contacts

Public ContactDorothee Speiser

Charité Universitaetsmedizin Berlin, Zentrum Familiärer Brust- und Eierstockkrebs (FBREK), Klinik für Gynäkologie mit Brustzentrum

dorothee.speiser@charite.de030450664825

Outcome results

None listed

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