Evidence map›Paper›PMID 27769293›Full record

Trial reportTrials2016

BRACAVENIR - impact of a psychoeducational intervention on expectations and coping in young women (aged 18-30 years) exposed to a high familial breast/ovarian cancer risk: study protocol for a randomized controlled trial.

Fabrice Kwiatkowski, Pascal Dessenne, Claire Laquet, Jean-Pierre Daures, Mathilde Gay-Bellile, Yves-Jean Bignon

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02705924 (Impact of a Psychoeducational Intervention on Expectations and Coping in Young Women), which is not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
0.7field-weighted citation impact, top 17% 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.

NCT02705924 naterminatednot on this map

Impact of a Psychoeducational Intervention on Expectations and Coping in Young Women (18-40 Years) Exposed to a High Familial Breast/Ovarian Cancer Risk

TypeinterventionalSponsorCentre Jean PerrinRan2016 to 2021Enrolled32ConditionsHereditary Breast and Ovarian Cancer SyndromeArmspsychoeducation
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 8 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. 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

6 authors at 2 institutions in 1 country.

Fabrice KwiatkowskiLaboratoire d'oncologie moléculaire, Centre Jean Perrin, 58 rue Montalembert, 63011, Clermont-Ferrand Cedex, France.ORCID 0000-0002-4041-3999
Pascal DessenneLaboratoire d'oncologie moléculaire, Centre Jean Perrin, 58 rue Montalembert, 63011, Clermont-Ferrand Cedex, France.
Claire LaquetLaboratoire d'oncologie moléculaire, Centre Jean Perrin, 58 rue Montalembert, 63011, Clermont-Ferrand Cedex, France.
Jean-Pierre DauresUPRES 2425, Décision médicale personnalisée, Montpellier, France.
Mathilde Gay-BellileLaboratoire d'oncologie moléculaire, Centre Jean Perrin, 58 rue Montalembert, 63011, Clermont-Ferrand Cedex, France.
Yves-Jean BignonLaboratoire d'oncologie moléculaire, Centre Jean Perrin, 58 rue Montalembert, 63011, Clermont-Ferrand Cedex, France. yves-jean.bignon@clermont.unicancer.fr.
Centre Jean Perrin · FRNeuropsychiatrie : Recherche Epidemiologique et Clinique · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundYoung women exposed to a high hereditary breast and ovarian cancer (HBOC) risk are particularly vulnerable. They are ignored by health prevention measures but exposed to a stream of contradictory information (medicine, media, Internet). They may feel concerned about surgical prevention issues at a key moment of their identity construction (self, relationship, sexuality). We designed a special psychoeducational intervention to help these women cope better with these difficulties. METHODS/

designThe BRACAVENIR study consists of a prospective, randomized superiority phase II trial with a wait list control group. Participants are childless young female counselees (aged 18-30 years) seen at the oncogenetics department of the Centre Jean Perrin and belonging to HBOC families either with or without BRCA mutations. They will be invited to attend a weekend group session at a spa resort and to participate in short expert conferences and focus group activities (group sharing, Moreno role game) supervised by a psychotherapist. Two sessions separated by a 6-month delay (wait list) will enable us to evaluate the intervention's effect by comparing questionnaire scores between the 6-month time points. The main endpoint is an increase of the Herth Hope Index by at least 1 SD. Secondary endpoints are self-esteem, anxiety trait, anxiety state, coping, and quality of life. With a one-sided α = 0.05 and β = 0.20, 12 participants will be needed by group, plus an additional 2 in anticipation of dropouts. Participants will be randomized 1:1 to the first or the second session so that the groups will be comparable. DISCUSSION: The intent of this trial is to bridge the gap on a psychosocial level in these young women with HBOC. A particularity of the design is the use of a waiting list, which should allow for avoiding major bias. The intervention consists of a short session that could be proposed to other young counselees if successful. The results may bring complementary information to facilitate the intervention and also influence the contents of the oncogenetic consultation.

trial registrationEthics committee CPP SUD-EST-6: IRB00008526. Registered on 18 March 2016. ClinicalTrials.gov identifier: NCT02705924 . Registered on 2 March 2016.

Indexed as

Adaptation, PsychologicalHealth Knowledge, Attitudes, PracticePsychotherapy, GroupAdolescentAdultBRCA1 ProteinBRCA2 ProteinBreast NeoplasmsClinical ProtocolsFemaleFranceGenetic Predisposition to DiseaseHeredityHumansMutationOvarian NeoplasmsBRCA1 ProteinBRCA1 protein, humanBRCA2 ProteinBRCA2 protein, human

Identifiers

PMID27769293
PMCPMC5073830
OpenAlexW2534236296

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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.