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

Fabrice Kwiatkowski, Pascal Dessenne, Claire Laquet, Jean-Pierre Daures, Mathilde Gay-Bellile, Yves-Jean Bignon, Fabrice Kwiatkowski, Pascal Dessenne, Claire Laquet, Jean-Pierre Daures, Mathilde Gay-Bellile, Yves-Jean Bignon

Abstract

Background: Young women exposed to a high hereditary breast and ovarian cancer (HBOC) risk are particularly vulnerable. They are ignored by health prevention measures but exposed to a stream of contradictory information (medicine, media, Internet). They may feel concerned about surgical prevention issues at a key moment of their identity construction (self, relationship, sexuality). We designed a special psychoeducational intervention to help these women cope better with these difficulties.

Methods/design: The BRACAVENIR study consists of a prospective, randomized superiority phase II trial with a wait list control group. Participants are childless young female counselees (aged 18-30 years) seen at the oncogenetics department of the Centre Jean Perrin and belonging to HBOC families either with or without BRCA mutations. They will be invited to attend a weekend group session at a spa resort and to participate in short expert conferences and focus group activities (group sharing, Moreno role game) supervised by a psychotherapist. Two sessions separated by a 6-month delay (wait list) will enable us to evaluate the intervention's effect by comparing questionnaire scores between the 6-month time points. The main endpoint is an increase of the Herth Hope Index by at least 1 SD. Secondary endpoints are self-esteem, anxiety trait, anxiety state, coping, and quality of life. With a one-sided α = 0.05 and β = 0.20, 12 participants will be needed by group, plus an additional 2 in anticipation of dropouts. Participants will be randomized 1:1 to the first or the second session so that the groups will be comparable.

Discussion: The intent of this trial is to bridge the gap on a psychosocial level in these young women with HBOC. A particularity of the design is the use of a waiting list, which should allow for avoiding major bias. The intervention consists of a short session that could be proposed to other young counselees if successful. The results may bring complementary information to facilitate the intervention and also influence the contents of the oncogenetic consultation.

Trial registration: Ethics committee CPP SUD-EST-6: IRB00008526. Registered on 18 March 2016. ClinicalTrials.gov identifier: NCT02705924 . Registered on 2 March 2016.

Figures

Fig. 1
Fig. 1
Construct of the psychological model enabling the evaluation of the study endpoints. HHI Herth Hope Index, IPC Internal, Powerful Others, and Chance Locus of Control Scales, QoL Quality of life, SES Self-Esteem Scale, STAI State-Trait Anxiety Inventory, WCC Ways of Coping Checklist, WHOQOL World Health Organization Quality of Life questionnaire

References

    1. McKinnon W, Naud S, Ashikaga T, Colletti R, Wood M. Results of an intervention for individuals and families with BRCA mutations: a model for providing medical updates and psychosocial support following genetic testing. J Genet Couns. 2007;16(4):433–56. doi: 10.1007/s10897-006-9078-8.
    1. Mauer C. Male attitudes on forming and maintaining romantic relationship with women who have BRCA1/2 mutations. Manchester: Presented at the 14th International Meeting on the Psychosocial Aspects of Hereditary Cancer; 2015.
    1. Kwiatkowski F, Dessenne P, Laquet C, Petit MF, Bignon YJ. Permanence of the information given during oncogenetic counseling to persons at familial risk of breast/ovarian and/or colon cancer. Eur J Hum Genet. 2012;20(2):141–7. doi: 10.1038/ejhg.2011.169.
    1. Després C, Dourgnon P, Fantin R, Jusot F. Le renoncement aux soins: une approche socio-anthropologique. Questions d’economie de la santé. 2011;(169). . Accessed 13 Oct 2016.
    1. Scheiffele E. The Theatre of Truth: psychodrama, spontaneity and improvisation; the theatrical theories and influences of Jacob Levy Moreno. Res Drama Educ J Appl Theatre Perform. 1997;2(2):227. doi: 10.1080/1356978970020211.
    1. Eisinger F, Bressac B, Castaigne D, Cottu PH, Lansac J, Lefranc JP, et al. Identification and management of hereditary predisposition to cancer of the breast and the ovary (update 2004) [in French] Bull Cancer. 2004;91(3):219–37.
    1. Evans DGR, Eccles DM, Rahman N, Young K, Bulman M, Amir E, et al. A new scoring system for the chances of identifying a BRCA1/2 mutation outperforms existing models including BRCAPRO. J Med Genet. 2004;41(6):474–80. doi: 10.1136/jmg.2003.017996.
    1. Evans DGR, Lalloo F, Wallace A, Rahman N. Update on the Manchester Scoring System for BRCA1 and BRCA2 testing. J Med Genet. 2005;42(7):e39. doi: 10.1136/jmg.2005.031989.
    1. Rosenberg M. Society and the adolescent self-image. Princeton: Princeton University Press; 1965.
    1. Spielberger CD. State-Trait Anxiety Inventory: a comprehensive bibliography. 2. Palo Alto: Consulting Psychologists Press; 1989.
    1. Spielberger CD, Gorsuch RL, Lushene R, Vagg PR, Jacobs GA. Manual for the State-Trait Anxiety Inventory. Palo Alto: Consulting Psychologists Press; 1983.
    1. Folkman S, Lazarus RS. An analysis of coping in a middle-aged community sample. J Health Soc Behav. 1980;21:219–39. doi: 10.2307/2136617.
    1. Folkman S, Lazarus RS. Manual for the Ways of Coping Questionnaire. Palo Alto: Consulting Psychologists Press; 1988.
    1. Levenson H. Differentiating among internality, powerful others, and chance. In: Lefcourt J, editor. Research with the locus of control construct. New York: Academic Press; 1981. pp. 15–63.
    1. Herth K. Abbreviated instrument to measure hope: development and psychometric evaluation, the Herth Hope Index. J Adv Nurs. 1992;17(10):1251–9. doi: 10.1111/j.1365-2648.1992.tb01843.x.
    1. Herth K. Enhancing hope in people with a first recurrence of cancer. J Adv Nurs. 2000;32(6):1431–41. doi: 10.1046/j.1365-2648.2000.01619.x.
    1. WHOQOL Group Development of the World Health Organization WHOQOL-BREF quality of life assessment. Psychol Med. 1998;28:551–8. doi: 10.1017/S0033291798006667.
    1. Dufault K, Martocchio BC. Symposium on compassionate care and the dying experience. Hope: its spheres and dimensions. Nurs Clin North Am. 1985;20(2):379–91.
    1. Rustøen T, Wiklund I, Hanestad BR, Moum T. Nursing intervention to increase hope and quality of life in newly diagnosed cancer patients. Cancer Nurs. 1998;21(4):235–45. doi: 10.1097/00002820-199808000-00003.
    1. Phillips-Salimi CR, Haase JE, Kintner EK, Monahan PO, Azzouz F. Psychometric properties of the Herth Hope Index in adolescents and young adults with cancer. J Nurs Meas. 2007;15(1):3–23. doi: 10.1891/106137407780851769.
    1. Davidson PM, Dracup K, Phillips J, Daly J, Padilla G. Preparing for the worst while hoping for the best: the relevance of hope in the heart failure illness trajectory. J Cardiovasc Nurs. 2007;22(3):159–65. doi: 10.1097/01.JCN.0000267821.74084.72.
    1. Davidson PM, Dracup K, Phillips J, Padilla G, Daly J. Maintaining hope in transition: a theoretical framework to guide interventions for people with heart failure. J Cardiovasc Nurs. 2007;22(1):58–64. doi: 10.1097/00005082-200701000-00009.
    1. Farran CJ, Herth KA, Popovich JM. Hope and hopelessness: critical clinical constructs. Thousand Oaks: Sage; 1995.
    1. Lafrance V. La notion d’espoir dans la reprise d’activités productives: perspectives d’individus ayant subi un accident vasculaire cérébral. Projet d’intégration présenté en 2013 à l’Université du Quebec à Trois-Rivières, pour la maîtrise en ergothérapie. Trois-Rivières: Université du Quebec; Aout 2013. . Accessed 13 Oct 2016.
    1. Gray-Little B, Williams VSL, Hancock TD. An item response theory analysis of the Rosenberg Self-Esteem Scale. Pers Soc Psychol Bull. 1997;23:443–51. doi: 10.1177/0146167297235001.
    1. Marshall SL, Parker PD, Ciarrochi J, Heaven PC. Is self-esteem a cause or consequence of social support? A 4-year longitudinal study. Child Dev. 2014;85(3):1275–91. doi: 10.1111/cdev.12176.
    1. Chan KS, Li HC, Chan SW, Lopez V. Herth Hope Index: psychometric testing of the Chinese version. J Adv Nurs. 2012;68(9):2079–85. doi: 10.1111/j.1365-2648.2011.05887.x.
    1. Vallieres EF, Vallerand RJ. Traduction et validation canadienne-française de l’échelle de l’estime de soi de Rosenberg. Int J Psychol. 1990;25(2):305–16. doi: 10.1080/00207599008247865.
    1. Schweitzer M, Paulhan I. Manuel pour l’inventaire d’Anxiété Trait-État (Forme Y) Bordeaux: Laboratoire de psychologie de la santé, Université de Bordeaux II; 1990.
    1. Beutler LE, Moos RH, Lane G. Coping, treatment planning, and treatment outcome: discussion. J Clin Psychol. 2003;59(10):1151–67. doi: 10.1002/jclp.10216.
    1. Lazarus RS, Folkman S. Stress, appraisal, and coping. New York: Springer; 1984.
    1. Vitaliano PP, Russo J, Carr JE, Maiuro RD, Becker J. The Ways of Coping Checklist: revision and psychometric properties. Multivariate Behav Res. 1985;20:3–26. doi: 10.1207/s15327906mbr2001_1.
    1. Bruchon-Schweitzer M, Cousson F, Quintard B, Nuissier J, Rascle N. French adaptation of the Ways of Coping Checklist. Percept Mot Skills. 1996;83(1):104–6. doi: 10.2466/pms.1996.83.1.104.
    1. Cousson-Gélie F, Cosnefroy O, Christophe V, Segrestan-Crouzet C, Merckaert I, Fournier E, et al. The Ways of Coping Checklist (WCC): validation in French-speaking cancer patients. J Health Psychol. 2010;15(8):1246–56. doi: 10.1177/1359105310364438.
    1. Levenson H. Multidimensional locus of control in psychiatric patients. J Consult Clin Psychol. 1973;41:397–404. doi: 10.1037/h0035357.
    1. Levenson H. Activism and powerful others: distinctions within the concept of internal-external control. J Pers Assess. 1974;38:377–83. doi: 10.1080/00223891.1974.10119988.
    1. Benassi VA, Sweeney PD, Dufour CL. Is there a relation between locus of control orientation and depression? J Abnorm Psychol. 1988;97(3):357–67. doi: 10.1037/0021-843X.97.3.357.
    1. 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) [in French] Ann Med Psychol (Paris) 1994;152(7):466–9.
    1. Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993;85(5):365–76. doi: 10.1093/jnci/85.5.365.
    1. Ware JE, Sherbourne CD. 36-item Short-Form Health Survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992;30(6):473–83. doi: 10.1097/00005650-199206000-00002.
    1. 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 [in French] Encéphale. 2000;26(5):13–22.
    1. Kwiatkowski F, Girard M, Hacene K, Berlie J. Sem: a suitable statistical software adapted for research in oncology [in French] Bull Cancer. 2000;87(10):715–21.
    1. Zigmond AS, Snaith RP. The Hospital Anxiety and Depression Scale. Acta Psychiatr Scand. 1983;67:367–70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
    1. Kwiatkowski F, Mouret-Reynier MA, Duclos M, Leger-Enreille A, Bridon F, Hahn T, et al. Long term improved quality of life by a 2-week group physical and educational intervention shortly after breast cancer chemotherapy completion: results of the ‘Programme of Accompanying women after breast Cancer treatment completion in Thermal resorts’ (PACThe) randomised clinical trial of 251 patients. Eur J Cancer. 2013;49(7):1530–8. doi: 10.1016/j.ejca.2012.12.021.

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