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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Impact of a Psychoeducational Intervention on Expectations and Coping in Young Women (18-30 Years) Exposed to a High Familial Breast/Ovarian Cancer Risk

Brief Summary:

Young female counselees (18-30 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 Summary:

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 (18-30 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.

Current Primary Outcome: changes in expectations measured using the Hert Hope Inventory questionnaire [ Time Frame: changes of global score from baseline to 6-month post-intervention. ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Dimensions of coping evaluated by the Ways of Coping Checklist (WCC) [Folkman, 1980]. [ Time Frame: inclusion - 6-month post-intervention - 1-year post-intervention ]

  The WCC French version contains 27 items quoted by Likert scales (answers within "no", "rather no", "rather yes", "yes"). Three specific dimensions are described:

  • the focus on the problem
  • the focus on emotions
  • the search for social support Dimensions will be used separately using their scores as no global score can be calculated (dimensions are divergent). This questionnaire has been validated in French in 1996 by Bruchon-Schweitzer et al.
• Dimensions of perceived control measured using the Internal Powerful others and Chance scale (IPC) [Levenson, 1973]. [ Time Frame: inclusion - 6-month post-intervention - 1-year post-intervention ]
  Perceived Control of IPC tests two locus of control: either in the self, or outside with two origins: fate/luck and "powerful others". Scores qualifying each locus of control will be used for statistics. This 24-item scale has been validated in French by Loas et al. [1994].
• 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] [ Time Frame: inclusion - 6-month post-intervention - 1-year post-intervention ]
  The STAI A-B questionnaire evaluates anxiety in a way it cannot be confused with depressive syndrome. It comprises 40 items rated on a 4-point scale from "almost never" to "almost always". The 20 first ones evaluate the anxiety as a state, that is a labile/contextual form. The last 20 items estimate anxiety as a personality trait, independent of the environment. It has been translated and validated in French by Schweitzer & Paulhan [1990].
• Score of the Self-Esteem Scale (SES) [Rosenberg, 1965] [ Time Frame: inclusion - 6-month post-intervention - 1-year post-intervention ]
  It is a short 10-item questionnaire that evaluates the global self-worth by questioning positive and negative feelings about the self. The uni-dimensionality of the scale has been validated [Gray-Little, 1997]. The global score of the scale will be used as an indicator of self-esteem.
• Subscales and global score of the WHO Quality of life questionnaire ( World Health Organization WHOQOL) [Harper, 1998]. [ Time Frame: inclusion - 6-month post-intervention - 1-year post-intervention ]
  This questionnaire is worldwidely used. It contains four main dimensions: physical health, psychological, social relationships and environment. These dimensions have been confirmed in the French version by Leplège et al. [2000]. The global QoL score (means of subscales) will also be used for statistics.

Original Secondary Outcome: Same as current

Information By: Centre Jean Perrin

Dates:
Date Received: March 2, 2016
Date Started: April 2016
Date Completion: October 2017
Last Updated: July 26, 2016
Last Verified: March 2016