Impact of a Psychoeducational Intervention on Expectations and Coping in Young Women Exposed to a High HBOC Risk
NCT ID: NCT02705924
Last Updated: 2021-11-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
32 participants
INTERVENTIONAL
2016-04-30
2021-09-14
Brief Summary
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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
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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.
psychoeducation
Participants will attend conferences where experts present the state of the art in various domains:
* Latest knowledge in oncogenetics
* Recommendations and morbidity of prophylactic breast surgeries and annexectomy
* Epidemiology of HBOC and comparative mortality risks with other syndromes/life habits
* How to perform the periodic breast screening
* Assisted medical procreation and embryo selection
* Importance of nutrition and physical activity as risk modulator
* Life habits: how one can increase or lower the cancer risk (tobacco, alcohol...)?
* Description of the assistance program (GENAUV) to help counselees exposed to a high cancer risk follow their medical screening.
The remaining time after this information, i.e. about half of the week-end, will comprise group activities, in particular role games (Moreno psychodrama approach) and group sharing under the supervision of a psychotherapist.
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.
psychoeducation
Participants will attend conferences where experts present the state of the art in various domains:
* Latest knowledge in oncogenetics
* Recommendations and morbidity of prophylactic breast surgeries and annexectomy
* Epidemiology of HBOC and comparative mortality risks with other syndromes/life habits
* How to perform the periodic breast screening
* Assisted medical procreation and embryo selection
* Importance of nutrition and physical activity as risk modulator
* Life habits: how one can increase or lower the cancer risk (tobacco, alcohol...)?
* Description of the assistance program (GENAUV) to help counselees exposed to a high cancer risk follow their medical screening.
The remaining time after this information, i.e. about half of the week-end, will comprise group activities, in particular role games (Moreno psychodrama approach) and group sharing under the supervision of a psychotherapist.
Interventions
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psychoeducation
Participants will attend conferences where experts present the state of the art in various domains:
* Latest knowledge in oncogenetics
* Recommendations and morbidity of prophylactic breast surgeries and annexectomy
* Epidemiology of HBOC and comparative mortality risks with other syndromes/life habits
* How to perform the periodic breast screening
* Assisted medical procreation and embryo selection
* Importance of nutrition and physical activity as risk modulator
* Life habits: how one can increase or lower the cancer risk (tobacco, alcohol...)?
* Description of the assistance program (GENAUV) to help counselees exposed to a high cancer risk follow their medical screening.
The remaining time after this information, i.e. about half of the week-end, will comprise group activities, in particular role games (Moreno psychodrama approach) and group sharing under the supervision of a psychotherapist.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
40 Years
FEMALE
No
Sponsors
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Fondation de l'Avenir et la MASFIP, Paris - France
UNKNOWN
Centre Jean Perrin
OTHER
Responsible Party
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Principal Investigators
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Yves-Jean BIGNON
Role: PRINCIPAL_INVESTIGATOR
Centre Jean Perrin
Locations
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Centre Jean Perrin
Clermont-Ferrand, Puy De Dome, France
Countries
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References
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Cousson-Gelie 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.
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. doi: 10.2466/pms.1996.83.1.104.
Herth K. Abbreviated instrument to measure hope: development and psychometric evaluation. J Adv Nurs. 1992 Oct;17(10):1251-9. doi: 10.1111/j.1365-2648.1992.tb01843.x.
Folkman S, Lazarus RS. An analysis of coping in a middle-aged community sample. J Health Soc Behav. 1980 Sep;21(3):219-39. No abstract available.
Levenson H. Multidimensional locus of control in psychiatric patients. J Consult Clin Psychol. 1973 Dec;41(3):397-404. doi: 10.1037/h0035357. No abstract available.
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.
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. doi: 10.1037//0278-6133.18.5.495.
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.
Herth K. Enhancing hope in people with a first recurrence of cancer. J Adv Nurs. 2000 Dec;32(6):1431-41. doi: 10.1046/j.1365-2648.2000.01619.x.
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.
Kwiatkowski F, Dessenne P, Laquet C, Daures JP, Gay-Bellile M, Bignon YJ. BRACAVENIR - impact of a psychoeducational intervention on expectations and coping in young women (aged 18-30 years) exposed to a high familial breast/ovarian cancer risk: study protocol for a randomized controlled trial. Trials. 2016 Oct 21;17(1):509. doi: 10.1186/s13063-016-1642-4.
Other Identifiers
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BRACAVENIR
Identifier Type: -
Identifier Source: org_study_id