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
Verified date | November 2021 |
Source | Centre Jean Perrin |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 32 |
Est. completion date | September 14, 2021 |
Est. primary completion date | September 14, 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Centre Jean Perrin | Clermont-Ferrand | Puy De Dome |
Lead Sponsor | Collaborator |
---|---|
Centre Jean Perrin | Fondation de l'Avenir et la MASFIP, Paris - France |
France,
Bruchon-Schweitzer M, Cousson F, Quintard B, Nuissier J, Rascle N. French adaptation of the Ways of Coping Checklist. Percept Mot Skills. 1996 Aug;83(1):104-6. — View Citation
Cousson-Gélie F, Cosnefroy O, Christophe V, Segrestan-Crouzet C, Merckaert I, Fournier E, Libert Y, Lafaye A, Razavi D. The Ways of Coping Checklist (WCC): validation in French-speaking cancer patients. J Health Psychol. 2010 Nov;15(8):1246-56. doi: 10.1177/1359105310364438. Epub 2010 Aug 27. — View Citation
Folkman S, Lazarus RS. An analysis of coping in a middle-aged community sample. J Health Soc Behav. 1980 Sep;21(3):219-39. — View Citation
Herth K. Abbreviated instrument to measure hope: development and psychometric evaluation. J Adv Nurs. 1992 Oct;17(10):1251-9. — View Citation
Herth K. Enhancing hope in people with a first recurrence of cancer. J Adv Nurs. 2000 Dec;32(6):1431-41. — View Citation
Leplège A, Réveillère C, Ecosse E, Caria A, Rivière 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. — View Citation
Levenson H. Multidimensional locus of control in psychiatric patients. J Consult Clin Psychol. 1973 Dec;41(3):397-404. — View Citation
Loas G, Dardennes R, Dhee-Perot P, Leclerc V, Fremaux D. [Operationalization of the "locus of control" concept: translation and first validation study of the Levenson control scale (IPC: the internal powerful others and chance scale)]. Ann Med Psychol (Paris). 1994 Aug-Sep;152(7):466-9. French. — View Citation
Power M, Harper A, Bullinger M. The World Health Organization WHOQOL-100: tests of the universality of Quality of Life in 15 different cultural groups worldwide. Health Psychol. 1999 Sep;18(5):495-505. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | changes in expectations measured using the Hert Hope Inventory questionnaire | 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]. | changes of global score from baseline to 6-month post-intervention. | |
Secondary | Dimensions of coping evaluated by the Ways of Coping Checklist (WCC) [Folkman, 1980]. | 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. |
inclusion - 6-month post-intervention - 1-year post-intervention | |
Secondary | Dimensions of perceived control measured using the Internal Powerful others and Chance scale (IPC) [Levenson, 1973]. | 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]. | inclusion - 6-month post-intervention - 1-year post-intervention | |
Secondary | 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] | 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]. | inclusion - 6-month post-intervention - 1-year post-intervention | |
Secondary | Score of the Self-Esteem Scale (SES) [Rosenberg, 1965] | 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. | inclusion - 6-month post-intervention - 1-year post-intervention | |
Secondary | Subscales and global score of the WHO Quality of life questionnaire ( World Health Organization WHOQOL) [Harper, 1998]. | 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. | inclusion - 6-month post-intervention - 1-year post-intervention |
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