Clinical trial NCT02705924: Impact of a Psychoeducational Intervention on Expectations and Coping in Young Women Exposed to a High HBOC Risk
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hereditary Breast and Ovarian Cancer Syndrome
Lead sponsor: Centre Jean Perrin
Sponsor class: OTHER
Collaborators: name: Fondation de l'Avenir et la MASFIP, Paris - France
First posted: 2016-03-11
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: changes in expectations measured using the Hert Hope Inventory questionnaire
timeFrame: changes of global score from baseline to 6-month post-intervention.
Secondary outcomes:
measure: Dimensions of coping evaluated by the Ways of Coping Checklist (WCC) [Folkman, 1980].
timeFrame: inclusion - 6-month post-intervention - 1-year post-intervention
measure: Dimensions of perceived control measured using the Internal Powerful others and Chance scale (IPC) [Levenson, 1973].
timeFrame: inclusion - 6-month post-intervention - 1-year post-intervention
measure: Level of Anxiety, either fundamental (as a trait of character) or superficial (depending on circumstances) evaluated by the State and Trait Anxiety Inventory (STAI A-B) [Spielberger, 1983]
timeFrame: inclusion - 6-month post-intervention - 1-year post-intervention
measure: Score of the Self-Esteem Scale (SES) [Rosenberg, 1965]
timeFrame: inclusion - 6-month post-intervention - 1-year post-intervention
measure: Subscales and global score of the WHO Quality of life questionnaire ( World Health Organization WHOQOL) [Harper, 1998].
timeFrame: inclusion - 6-month post-intervention - 1-year post-intervention
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin
state: Puy De Dome
Study officials:
affiliation: Centre Jean Perrin
name: Yves-Jean BIGNON
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Leplege A, Reveillere C, Ecosse E, Caria A, Riviere H. [Psychometric properties of a new instrument for evaluating quality of life, the WHOQOL-26, in a population of patients with neuromuscular diseases]. Encephale. 2000 Sep-Oct;26(5):13-22. French.
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citation: Kwiatkowski F, Gay-Bellile M, Dessenne P, Laquet C, Boussion V, Beguinot M, Petit MF, Gremeau AS, Verlet C, Chaptal C, Broult M, Jouvency S, Duclos M, Bignon YJ. BRACAVENIR: an observational study of expectations and coping in young women with high hereditary risk of breast and ovarian cancer. Hered Cancer Clin Pract. 2019 Feb 27;17:7. doi: 10.1186/s13053-019-0107-7. eCollection 2019.
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