Ignite Creation Date:
2024-05-06 @ 8:17 AM
Last Modification Date:
2024-10-26 @ 11:58 AM
Study NCT ID:
NCT02705924
Status:
TERMINATED
Last Update Posted:
2021-11-30
First Post:
2016-03-02
Brief Title:
Impact of a Psychoeducational Intervention on Expectations and Coping in Young Women Exposed to a High HBOC Risk
Sponsor:
Centre Jean Perrin
Organization:
Centre Jean Perrin
Study Overview
Official Title:
Impact of a Psychoeducational Intervention on Expectations and Coping in Young Women 18-40 Years Exposed to a High Familial BreastOvarian Cancer Risk
Status:
TERMINATED
Status Verified Date:
2021-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
COVID19 crisis prevents from organizing the last seminar
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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:
Background Young women exposed to a high hereditary breastovaries 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
Methodsdesign 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 11 to the first or the second session so that groups are comparable Session will be cost-free for participants
Methodsdesign 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 11 to the first or the second session so that groups are comparable Session will be cost-free for participants
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None