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

Centre Jean Perrin

Status: Terminated

Conditions: Hereditary Breast and Ovarian Cancer Syndrome

Treatments: Behavioral: psychoeducation

Study type: Interventional

Funder types: Other

Identifiers

NCT02705924

BRACAVENIR

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

Psychoeducational intervention

Experimental group

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.

Treatment:

Behavioral: psychoeducation

Waiting list

Other group

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.

Treatment:

Behavioral: psychoeducation