Clinical trial · Interventional
Impact of a Psychoeducational Intervention on Expectations and Coping in Young Women Exposed to a High HBOC Risk
Impact of a Psychoeducational Intervention on Expectations and Coping in Young Women (18-40 Years) Exposed to a High Familial Breast/Ovarian Cancer Risk
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): COVID19 crisis prevents from organizing the last seminar
Summary
Brief summary (as posted)
Young female counselees (18-40 years) belonging to HBOC families with a known mutation on BRCA-genes or not, receive a lot of information regarding their cancer risk. Information sources are numerous and sometimes contradictory. Unfortunately, these women face these issues at a key moment of there identity construction (self, relationship, sexuality) while they are not yet concerned by health prevention measures. A special psychoeducational intervention was designed to help these women to better cope with these difficulties. Intervention consists in a week-end session in a thermal center (SPA) during which they will attend short conferences given by specialists (prevention measures, prophylactic surgery, assisted procreation, epidemiology...) and participate to role games and group sharing. Intervention will be evaluated using self-questionnaires completed before intervention and during the following year.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hereditary Breast and Ovarian Cancer Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| psychoeducation | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Psychoeducational intervention
- description
- group participating to the first psychoeducational intervention: it consists in a week-end session in a SPA center including several conferences about HBOC familial risk, cancer prevention, prophylactic possibilities (surgery), recommendations about nutrition and physical activity a risk modulators, assisted medical procreation and embryo selection, social support...). Besides conferences, Moreno role games and group sharing are organized under the supervision of a psychotherapist.
- interventionNames
- Behavioral: psychoeducation
- type
- OTHER
- label
- Waiting list
- description
- delayed intervention: group participating to the second psychoeducational intervention (6 months later). Intervention is same as in the intervention arm but it is delayed. Because questionnaires are completed before this second intervention in both arms and allocation to arms are randomized, it represents an adequate control group.
- interventionNames
- Behavioral: psychoeducation
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * Participants must belong to HBOC families, * aged between 18 and 40 years * Single or couple with a desire to have a child * without any personal history of cancer. * must have consulted at the oncogenetics department of the CCC Jean Perrin * tested for a BRCA mutation. * mutation carrier in case of a known familial BRCA mutation, else exposed to a high familial HBOC risk (Eisinger score ≥ 6 or Manchester score ≥ 16) * must live in Auvergne region (middle France) * signed an informed consent before inclusion. Exclusion Criteria: * pregnant women * person who cannot answer questionnaires: language difficulties and/or cannot write in French correctly. * no possible connection to our web-site * psychiatric troubles and/or ongoing treatments preventing from a week-end stay in a SPA resort
References
Publications (11)
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- BACKGROUNDPower M, Harper A, Bullinger M. The World Health Organization WHOQOL-100: tests of the universality of Quality of Life in 15 different cultural groups worldwide. Health Psychol. 1999 Sep;18(5):495-505. doi: 10.1037//0278-6133.18.5.495. PMID 10519466
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