Impact of a Psychoeducational Intervention on Expectations and Coping in Young Women Exposed to a High HBOC Risk

Hereditary Breast and Ovarian Cancer Syndrome Clinical Trial

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

Status Terminated

Clinical Trial Summary

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.

Clinical Trial Description

Background: Young women exposed to a high hereditary breast/ovaries cancer (HBOC) risk are particularly vulnerable: they are ignored by health prevention measures; they are embedded in a stream of contradictory information ( medicine, media, internet); they may feel concerned by surgical prevention issues at a key moment of there identity construction (self, relationship, sexuality). A special psychoeducational intervention was designed to help these women to better cope with these difficulties. Methods/design: the study consists in a prospective randomized trial including childless young female counselees (18-40 years) of CCC Jean Perrin oncogenetics department, belonging to HBOC families either BRCA-mutated or not. They will be invited to attend a weekend group session in a SPA resort and participate to a series of short expert conferences and to focus group activities (group sharing, Moreno role game) supervised by a psychotherapist. Two sessions separated by a 6-month delay (waiting list) will enable us to evaluate the intervention effect, by comparing the evolution of questionnaires scores between inclusion and 6-month post-intervention. Main end-point is an increase of the Hert Hope Inventory of at least one standard deviation. Secondary endpoints investigate self-esteem, anxiety-trait, anxiety-state, ways of coping and quality of life. Participants will be randomized 1:1 to the first or the second session so that groups are comparable. Session will be cost-free for participants. ;

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Hereditary Breast and Ovarian Cancer Syndrome
• Ovarian Neoplasms

• NCT number: NCT02705924
• Study type: Interventional
• Source: Centre Jean Perrin
• Status: Terminated
• Phase: N/A
• Start date: April 2016
• Completion date: September 14, 2021