Evidence map›Paper›PMID 32513307›Full record

ArticleTrials2020

Implementation and evaluation of a nurse-led decision-coaching program for healthy breast cancer susceptibility gene (BRCA1/2) mutation carriers: a study protocol for the randomized controlled EDCP-BRCA study.

A Isselhard, M Töpper, B Berger-Höger, A Steckelberg, H Fischer, F Vitinius, K Beifus, J Köberlein-Neu, R Wiedemann, K Rhiem and 2 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
2.7field-weighted citation impact, top 10% of its field
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

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 24 citations in OpenAlex.

  1. Decision aids for people facing health treatment or screening decisions.The Cochrane database of systematic reviews · 2024
    Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. Review
  7. Article
  8. Decision Aids for Preventive Treatment Alternatives forGeburtshilfe und Frauenheilkunde · 2021
    Article
  9. Article
  10. Article
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

12 authors at 4 institutions in 1 country.

A IsselhardInstitute of Health Economics and Clinical Epidemiology, University Hospital of Cologne, Cologne, Germany. anna.isselhard@uk-koeln.de.ORCID http://orcid.org/0000-0001-5196-5716
M TöpperInstitute of Health Economics and Clinical Epidemiology, University Hospital of Cologne, Cologne, Germany.
B Berger-HögerInstitute for Health and Nursing Science, Faculty of Medicine, Martin Luther University Halle-Wittenberg, Halle (Saale), Germany.
A SteckelbergInstitute for Health and Nursing Science, Faculty of Medicine, Martin Luther University Halle-Wittenberg, Halle (Saale), Germany.
H FischerDepartment of Psychosomatics and Psychotherapy, Faculty of Medicine, University Hospital Cologne, University of Cologne, Cologne, Germany.
F VitiniusDepartment of Psychosomatics and Psychotherapy, Faculty of Medicine, University Hospital Cologne, University of Cologne, Cologne, Germany.
K BeifusCenter for Health Economics and Health Services Research, Schumpeter School of Business and Economics, University of Wuppertal, Wuppertal, Germany.
J Köberlein-NeuCenter for Health Economics and Health Services Research, Schumpeter School of Business and Economics, University of Wuppertal, Wuppertal, Germany.
R WiedemannCenter for Familial Breast and Ovarian Cancer, Center for Integrated Oncology (CIO), University of Cologne, Faculty of Medicine and University Hospital Cologne, Cologne, Germany.
K RhiemCenter for Familial Breast and Ovarian Cancer, Center for Integrated Oncology (CIO), University of Cologne, Faculty of Medicine and University Hospital Cologne, Cologne, Germany.
R SchmutzlerCenter for Familial Breast and Ovarian Cancer, Center for Integrated Oncology (CIO), University of Cologne, Faculty of Medicine and University Hospital Cologne, Cologne, Germany.
S StockInstitute of Health Economics and Clinical Epidemiology, University Hospital of Cologne, Cologne, Germany.
University of Cologne · DEUniversity Hospital Cologne · DEMartin Luther University Halle-Wittenberg · DEUniversity of Wuppertal · DE

Funding

German Federal Joint Committee (GBA) Innovationsfonds 01VSF17043
6 · The paper itself

Abstract

backgroundFemale BRCA mutation carriers have an increased lifetime risk for breast and ovarian cancer compared to the general population. Women who carry this mutation have several options to deal with their cancer risk, such as risk-reducing surgeries or intensified breast cancer screening. Previous research has shown that preferences in this scenario are highly dependent on affected women's personalities and value systems. To support these women in the decision-making process, a structured decision support consisting of decision coaching combined with a decision aid might be helpful. METHODS/

designA randomized controlled trial will be conducted in order to compare usual care with structured decision support alongside usual care. The decision support program entails nurse-led decision coaching as well as an evidence-based patient decision aid. Nurses are qualified by a 4-day training program in informed decision-making and decision coaching. Six centers for Familial Breast and Ovarian Cancer in Germany will be included in the study, with a planned sample size of 398 women. The primary outcome is the congruence between the preferred and the actual played role in the decision-making process as measured by the Control Preferences Scale. It is hypothesized that the structured decision support will enable women to play the preferred role in the decision-making process. Secondary outcomes include the knowledge and attitudes about preventive options, decisional conflict, depression and anxiety, coping self-efficacy, impact of event, and self-concept. A process evaluation will accompany the study. DISCUSSION: The EDCP-BRCA study is the first study to implement and evaluate decision coaching combined with a decision aid for healthy BRCA mutation carriers worldwide. TRIAL REGISTRATION {2A}: DRKS-ID: DRKS00015527. Registered 30 October 2019.

Indexed as

Genes, BRCA1Genes, BRCA2Nurse-Patient RelationsBreast NeoplasmsDecision Support TechniquesFemaleGenetic CounselingGenetic Predisposition to DiseaseGermanyHeterozygoteHumansMulticenter Studies as TopicMutationRandomized Controlled Trials as TopicBRCA1 and BRCA2Decision aidDecision coachingDecision makingFamilial breast cancerFamilial ovarian cancerPatient-centered careShared decision-making

Identifiers

PMID32513307
PMCPMC7278068
OpenAlexW3033672583

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.