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

NCT02705924 | Terminated

• 1 other identifier: BRACAVENIR
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hereditary Breast and Ovarian Cancer Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (2)

Psychoeducational intervention

EXPERIMENTAL

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.

Behavioral: psychoeducation

Waiting list

OTHER

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.

Behavioral: psychoeducation

Interventions

psychoeducation BEHAVIORAL

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.

Psychoeducational intervention; Waiting list

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Jean Perrin: lead
• Fondation de l'Avenir et la MASFIP, Paris - France: collaborator

Study Sites (1)

Centre Jean Perrin

Clermont-Ferrand, Puy De Dome, 63011, France

Location

Related Publications (11)

• 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.

  PMID: 20801945 BACKGROUND

• 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.

  PMID: 8873181 BACKGROUND

• 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.

  PMID: 1430629 BACKGROUND

• 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.

  PMID: 7410799 BACKGROUND

• 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.

  PMID: 4803272 BACKGROUND

• 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.

  PMID: 7978779 BACKGROUND

• 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.

  PMID: 10519466 BACKGROUND

• 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.

  PMID: 11192800 BACKGROUND

• 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.

  PMID: 11136411 RESULT

• 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.

  PMID: 30858899 DERIVED

• 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.

  PMID: 27769293 DERIVED

MeSH Terms

Conditions

Hereditary Breast and Ovarian Cancer Syndrome

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplastic Syndromes, Hereditary; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Yves-Jean BIGNON

  Centre Jean Perrin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2016
• First Posted: March 11, 2016
• Study Start: April 1, 2016
• Primary Completion: September 14, 2021
• Study Completion: September 14, 2021
• Last Updated: November 30, 2021

Record last verified: 2021-11

Locations

FR (1)