Viewing Study NCT05095675



Ignite Creation Date: 2024-05-06 @ 4:49 PM
Last Modification Date: 2024-10-26 @ 2:16 PM
Study NCT ID: NCT05095675
Status: RECRUITING
Last Update Posted: 2023-06-28
First Post: 2021-01-20

Brief Title: Predicting Effective Adaptation to Breast Cancer to Help Women to BOUNCE Back
Sponsor: European Institute of Oncology
Organization: European Institute of Oncology

Study Overview

Official Title: Predicting Effective Adaptation to Breast Cancer to Help Women to BOUNCE Back a Multicentre Clinical Pilot Study
Status: RECRUITING
Status Verified Date: 2023-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: BOUNCE
Brief Summary: Breast cancer accounts for 28 of all cancer cases in Europe WHO 2018 Coping with breast cancer is becoming an increasingly burdensome socio-economic challenge partly due to the increasing incidence registered in the last years which is occurring despite continuous advances in medicine This said mortality rate has decreased significantly as 5-year survival rate has risen from 75 to 90 Breast Cancer Research Foundation 2016 For these reasons the number of cancer survivors has grown with important effects on quality of life even years after the end of treatments

The process of successful adaptation to breast cancer and the various accompanying stressors can be conceptually defined as the persons resilience Resilience is a complex construct that can be defined on different levels an individuals potential capacity to engage in adaptive coping processes a process adaptive reactions to adversity and an outcome the final state achieved as the result of coping

While theoretical contributions regarding resilience models in medical settings have been advanced Deshields et al 2016 to date no one has tested the integrated contributing role of multiple psychological biological and functional variables in predicting the patients ability to bounce back from the stressful life event of being diagnosed with breast cancer Resilience is going to be measured through a data-driven method computation of resilience index on the basis of retrospective data and through a psychometric method various domains of resilience through questionnaires

There is a growing need for novel strategies to improve the understanding and the capacity to predict resilience of women to the variety of stressful experiences

BOUNCE European Project H2020 European Project Predicting Effective Adaptation to Breast Cancer to Help Women to BOUNCE back Grant Agreement Nr 777167 will bring together modelling medical and social sciences experts to advance current knowledge on the dynamic nature of resilience as it relates to improved quality of life

The broad and general objective of the BOUNCE project is to build a quantitative mathematical model of factors associated with optimal adjustment capacity to cancer The investigators will collect biomedical status BMS the psychosocial status PSS and the functional status FUS of breast cancer patients that literature demonstrated to be predictive of patients capacity to bounce back during the highly stressful treatment and recovery period following diagnosis of breast cancer The overarching goal of the model is to understand which factors predict optimal adjustment to breast cancer and which combination of factors undermine adjustment This would allow early identification of women at risk for which it is better to intervene through a personalised psychological support

Funding The BOUNCE Project Predicting Effective Adaptation to Breast Cancer to Help Women to BOUNCE back has received funding from the European Unions Horizon 2020 research and innovation programme Project type H2020 - SCI-2017-CNECT-2 Project type H2020 - SCI-2017-CNECT-2 Grant Agreement Nr 777167
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None