Proof of efficacy of the GenE³ app to support patients with hereditary breast and ovarian cancer during the genetic counseling process

Proof of efficacy of the GenE³ app to support patients with hereditary breast and ovarian cancer during the genetic counseling process - GenE³-App-Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00040493

Enrollment

240

Registered

2026-06-12

Start date

2026-10-01

Completion date

Unknown

Last updated

2026-06-22

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

Conditions

Z80.3

Interventions

Group 1: In a prospective, single-center, two-arm, randomized, open-label, controlled intervention study with an intervention and a control group (GenE3 app + informational flyer vs. informational fly

Eligibility

Sex/Gender

Female

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Appointment for genetic counseling on hereditary breast and ovarian cancer (HBOC) at the Department of Human Genetics at Hannover Medical School (MHH).

Exclusion criteria

Exclusion criteria: No knowledge of German

Design outcomes

Primary

Measure	Time frame
Co-primary endpoints: • Change in patients’ health literacy measured using Domain 2 (“Having sufficient information to manage my health”) of the Health Literacy Questionnaire (HLQ) • Need for therapeutic support due to psychosocial problems associated with genetic counseling, measured using Domain 2 (“Hereditary predisposition”) of the Psychosocial Aspects of Hereditary Cancer (PAHC) questionnaire	—

Measure

Time frame

Co-primary endpoints: • Change in patients’ health literacy measured using Domain 2 (“Having sufficient information to manage my health”) of the Health Literacy Questionnaire (HLQ) • Need for therapeutic support due to psychosocial problems associated with genetic counseling, measured using Domain 2 (“Hereditary predisposition”) of the Psychosocial Aspects of Hereditary Cancer (PAHC) questionnaire

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Secondary

Measure	Time frame
Secondary endpoints: • Change in anxiety and depression: Hospital Anxiety and Depression Scale (HADS) • Change in health literacy: Domains 1 and 3–9 of the HLQ • Change in psychosocial problems: Domains 1 and 3–6 of the PAHC • Change in psychological distress: Multidimensional Impact of Cancer Risk Assessment (MICRA) • Satisfaction with genetic counseling: Genetic Counseling Satisfaction Scale (GCSS) • Frequency of GenE³ app use: integrated tracking system • Suggested improvements to the GenE³ app: five-star rating scale and System Usability Scale (SUS) • Number of participants’ family members who received genetic counseling/testing, assessed in a follow-up two months after MP4. • Information resources used after completion of the study, assessed during the telephone follow-up two months after MP4.	—

Measure

Time frame

Secondary endpoints: • Change in anxiety and depression: Hospital Anxiety and Depression Scale (HADS) • Change in health literacy: Domains 1 and 3–9 of the HLQ • Change in psychosocial problems: Domains 1 and 3–6 of the PAHC • Change in psychological distress: Multidimensional Impact of Cancer Risk Assessment (MICRA) • Satisfaction with genetic counseling: Genetic Counseling Satisfaction Scale (GCSS) • Frequency of GenE³ app use: integrated tracking system • Suggested improvements to the GenE³ app: five-star rating scale and System Usability Scale (SUS) • Number of participants’ family members who received genetic counseling/testing, assessed in a follow-up two months after MP4. • Information resources used after completion of the study, assessed during the telephone follow-up two months after MP4.

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Countries

Germany

Contacts

Public ContactBeate Vajen

Medizinische Hochschule Hannover

vajen.beate@mh-hannover.de+4951153280831

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 29, 2026