Impact of a Psychoeducational Intervention on Expectations and Coping in Young Women (18-40 Years) Exposed to a High Familial Breast/Ovarian Cancer Risk
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- changes in expectations measured using the Hert Hope Inventory questionnaire
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Psychoeducational intervention
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.
干预措施: psychoeducation (Behavioral)
Waiting list
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.
干预措施: psychoeducation (Behavioral)
结局指标
主要结局
changes in expectations measured using the Hert Hope Inventory questionnaire
时间窗: changes of global score from baseline to 6-month post-intervention.
Hert Hope Inventory global score \[Herth, 1992, 2000\] is used to evaluate expectations of participants. It contains only 12 simple proposals quoted using a 4-point Likert scale ranking from 1 = "strongly disagree" to 4 = "strongly agree". Its internal structure is composed of three dimensions: temporality and future, positive readiness and expectancy, and social/spiritual connectedness \[Farran, 1995\]. This questionnaire has been translated and validated in French by Lafrance \[2013\].
次要结局
- Dimensions of coping evaluated by the Ways of Coping Checklist (WCC) [Folkman, 1980].(inclusion - 6-month post-intervention - 1-year post-intervention)
- Dimensions of perceived control measured using the Internal Powerful others and Chance scale (IPC) [Levenson, 1973].(inclusion - 6-month post-intervention - 1-year post-intervention)
- 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](inclusion - 6-month post-intervention - 1-year post-intervention)
- Score of the Self-Esteem Scale (SES) [Rosenberg, 1965](inclusion - 6-month post-intervention - 1-year post-intervention)
- Subscales and global score of the WHO Quality of life questionnaire ( World Health Organization WHOQOL) [Harper, 1998].(inclusion - 6-month post-intervention - 1-year post-intervention)