Helping women adapt to breast cancer

Predicting Effective Adaptation to Breast Cancer to Help Women to BOUNCE Back: a Multicentre Clinical Pilot Study

This study looks at how women with breast cancer can better cope with their diagnosis and treatment by understanding what helps them stay strong and resilient.

Quick facts

• Study type: Observational
• Enrollment: 660 (estimated)
• Ages: 18 Years to 70 Years
• Sex: Female
• Sponsor: European Institute of Oncology (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Milan)
• Trial ID: NCT05095675 on ClinicalTrials.gov

What this trial studies

This observational study aims to understand how women with breast cancer can effectively adapt to their diagnosis and treatment through the lens of resilience. By utilizing psychological questionnaires, the study seeks to identify factors that contribute to successful coping mechanisms among patients with early or locally advanced operable breast cancer. The focus is on understanding resilience as a multi-faceted construct that encompasses individual potential, adaptive processes, and outcomes. The findings could provide insights into improving the quality of life for breast cancer survivors.

Who should consider this trial

Good fit: Ideal candidates include women diagnosed with early or locally advanced operable breast cancer who are undergoing surgery and possibly systemic treatment.

Not a fit: Patients with distant metastases or a history of severe mental disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance support strategies for breast cancer patients, leading to improved coping and quality of life.

How similar studies have performed: While studies on resilience in cancer patients exist, this specific approach focusing on predictive modeling for adaptation is relatively novel.

Eligibility criteria

Inclusion Criteria:

* Presence of a devoted informed consent signed by the patient and the physician
* Histologically confirmed invasive early or locally advanced operable breast cancer
* Tumour stage I, II and III
* Patients receiving surgery as part of the local treatment
* Patients receiving any type of systemic treatment regardless of treatment type and/or adjuvant radiation therapy if indicated as part of the local treatment

Exclusion Criteria:

* Refusal to sign informed consent
* Presence of distant metastases
* History of another malignancy or contralateral invasive breast cancer within the last five years except cured basal cell carcinoma of skin or carcinoma in situ of the uterine cervix
* History of early onset (i.e., before 40 years of age) mental disorder (i.e., schizophrenia, psychosis, bipolar disorder, diagnosis of major depression) or severe neurologic disorder (i.e., neurodegenerative disorder, dementia)
* Serious other diagnosed concomitant diseases such as clinically significant (i.e. active) cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease or cardiac arrhythmia not well controlled with medication) or myocardial infarction within the last 12 months.
* Major surgery for a severe disease or trauma which could affect patient's psychosocial wellbeing (for example, major heart or abdominal surgery) within 4 weeks prior to study entry or lack of complete recovery from the effects of surgery
* Treatment for invasive cancer
* Treatment for any major illness in the last half year
* Pregnancy or breastfeeding at time of recruitment

Where this trial is running

Milan

• European Institute of Oncology — Milan, Italy (Recruiting)

Study contacts

• Principal investigator: Ketti Mazzocco — European Institute of Oncology
• Study coordinator: Ketti Mazzocco

Conditions Breast Cancer; Resilience; Predictive model