Evidence map›Paper›PMID 40457381›Full record

ArticleTrials2025

dVP_FAM-development and evaluation of a transsectoral digital care platform for individuals with familial cancer risks: study protocol for a multi-centre, cluster-randomised, mixed-methods study.

K Klein, F Kendel, S Schüürhuis, K Neumann, C Kowalski, P Thomas, T Reinhold, U Felbor, S Stegen, C Schmid and 5 more

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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0cells of the map it votes in
0citing papers in PubMed
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1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

K Klein *Department of Anesthesiology and Intensive Care Medicine, Charité - Universitätsmedizin, Corporate Member of Freie Universität and Humboldt Universität zu Berlin, Berlin, Germany. katharina.klein@charite.de.
F Kendel *Department of Anesthesiology and Intensive Care Medicine, Charité - Universitätsmedizin, Corporate Member of Freie Universität and Humboldt Universität zu Berlin, Berlin, Germany.
S SchüürhuisInstitute of Biometry and Clinical Epidemiology, Charité - Universitätsmedizin, corporate member of, Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
K NeumannInstitute of Biometry and Clinical Epidemiology, Charité - Universitätsmedizin, corporate member of, Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
C KowalskiDeutsche Krebsgesellschaft e.V, Berlin, Germany.
P ThomasDepartment of Anesthesiology and Intensive Care Medicine, Charité - Universitätsmedizin, Corporate Member of Freie Universität and Humboldt Universität zu Berlin, Berlin, Germany.
T ReinholdInstitute of Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin, Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
U FelborDepartment of Human Genetics, Interfaculty Institute of Genetics and Functional Genomics, University Medicine Greifswald, and, University of Greifswald , Greifswald, Germany.
S StegenBRCA-Netzwerk E.V, Hilfe bei Familiären Krebserkrankungen, Bonn, Germany.
C SchmidDivision of Ergonomics, Department of Psychology and Ergonomics, Technische Universität Berlin, Berlin, Germany.
N MehrhofDepartment of Gynecology with Breast Center, Hereditary Breast and Ovarian Cancer Center, Charité - Universitätsmedizin, Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
S AsmussenFaculty of Law, Civil Law, Commercial Law and Economics, Humboldt-Universität zu Berlin, Berlin, Germany.
F DielKassenärztliche Bundesvereinigung, Berlin, Germany.
M A Feufel *Division of Ergonomics, Department of Psychology and Ergonomics, Technische Universität Berlin, Berlin, Germany.
D Speiser *Department of Gynecology with Breast Center, Hereditary Breast and Ovarian Cancer Center, Charité - Universitätsmedizin, Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.

Funding

Gemeinsame Bundesausschuss 01NVF20002
6 · The paper itself

Abstract

backgroundIndividuals with a family history of cancer face an increased risk of developing breast and ovarian cancer. Up to 30% of the 70,000 annual breast cancer cases in Germany are associated with a familial cancer burden. Early identification of these risks is crucial as personalised measures can enable early detection or prevention of cancer. Primary care gynaecologists are uniquely suited to assess family histories and facilitate referrals to hereditary cancer centres. However, solutions on how to support early referral are still lacking. This study evaluates the impact of the digital care platform dVP_FAM as a potential remedy compared to standard care. The primary hypothesis is that the platform will increase the proportion of care-seeking women with a familial cancer risk who have not yet developed cancer. Secondary outcomes include improvements in care efficiency, patient empowerment, and health-related quality of life.

methodsThe study is a multi-centre, cluster-randomised, mixed-method trial involving 44 gynaecological centres and 800 participants recruited through hereditary breast and ovarian cancer centres. All participants receive standard guideline-based care, while the intervention group also uses the dVP_FAM platform. The primary endpoint measures the proportion of participants with a familial cancer history who are cancer-free when seeking specialist counselling. Secondary outcomes are assessed using validated tools like the SF-12 and custom measures. Data collection employs a convergent mixed-methods approach, integrating quantitative and qualitative evidence. DISCUSSION: The dVP_FAM platform represents an innovative approach to digitising cancer prevention in Germany, enhancing early detection and care coordination. If successful, dVP_FAM could serve as a scalable model for digital health innovations, improving efficiency and modernising the delivery of personalised care across health systems.

trial registrationGerman Clinical Trials Register, DRKS00030371 . Registered on 02 October 2023.

Indexed as

Breast NeoplasmsEarly Detection of CancerOvarian NeoplasmsTelemedicineFemaleGenetic Predisposition to DiseaseGermanyHumansMulticenter Studies as TopicQuality of LifeRandomized Controlled Trials as TopicRisk AssessmentCancer preventionDigital healthEarly detectionFamilial cancer riskGenetic counsellingHealthcare efficiencyHereditary breast and ovarian cancerPatient empowermentPrimary care gynaecologistsQuality of life

Identifiers

PMID40457381
PMCPMC12128308

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.