Predicting Effective Adaptation to Breast Cancer to Help Women to BOUNCE Back

NCT05095675 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 660

Last updated 2023-06-28

No results posted yet for this study

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 person's resilience. Resilience is a complex construct that can be defined on different levels: an individual's 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 patient's 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 Union's Horizon 2020 research and innovation programme, Project type: H2020 - SCI-2017-CNECT-2; Project type: H2020 - SCI-2017-CNECT-2; Grant Agreement Nr: 777167.

Conditions

Interventions

BEHAVIORAL

psychological questionnaires

Participants have to fulfill psychological questionnaires in different time points during medical oncological treatment

Sponsors & Collaborators

  • Helsinki University Central Hospital

    collaborator OTHER
  • Hebrew University of Jerusalem

    collaborator OTHER
  • Fundacao Champalimaud

    collaborator OTHER
  • Foundation for Research and Technology - Hellas

    collaborator UNKNOWN
  • Institute of Communications and Computer Systems, Athens, Greece

    collaborator OTHER
  • SINGULARLOGIC

    collaborator UNKNOWN
  • NHG CONSULTING OY

    collaborator UNKNOWN
  • Noona Healthcare

    collaborator UNKNOWN
  • European Institute of Oncology

    lead OTHER

Principal Investigators

  • Ketti Mazzocco · European Institute of Oncology

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-06
Primary Completion
2021-12-31
Completion
2023-12-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05095675 on ClinicalTrials.gov