Financial Toxicity in Patients With Early-stage Breast Cancer

NCT07354165 | Recruiting

• 1 other identifier: VOICE - GIM36
• Study Type: observational
• Target: 864
• Locations: 1 country
• Sites: 1

Brief Summary

Non-profit, multicenter, prospective, observational study. This study aims to evaluate whether the articulated treatment algorithm that is now possible for early-stage breast cancer patients does produce tangible changes of financial distress over the time and whether the determinants of financial distress change their relative weight over the time.

Conditions

Breast Cancer

Keywords

early breast cancer; financial toxicity; quality of life; PROFFIT questionnaire

Outcome Measures

Primary Outcomes (1)

• Financial Toxicity at one year

  The rate of patients with early breast cancer experiencing financial toxicity (defined as a change of ≥18 points in the PROFFIT-score \[items 1-7\]) one year after the beginning of the first oncological treatment

  baseline visit (before surgery or chemotherapy/endocrine therapy depending on the cohort), at the end of chemotherapy/endocrine therapy (if applicable), after surgery, 6 months after surgery, 1 year after the baseline questionnaires

Secondary Outcomes (4)

• Changes in PROFFIT scores

  baseline, at the end of chemotherapy/endocrine therapy (if applicable), after surgery, 6 months after surgery, 1 year after the baseline questionnaires, then every 6 months during endocrine therapy/other treatments/follow-up until 5 yrs from baseline

• Financial toxicity "Determinants"

  baseline, at the end of chemotherapy/endocrine therapy (if applicable), after surgery, 6 months after surgery, 1 year after the baseline questionnaires, then every 6 months during endocrine therapy/other treatments/follow-up until 5 yrs from baseline

• PROFFIT score and survival

  baseline, at the end of chemotherapy/endocrine therapy (if applicable), after surgery, 6 months after surgery, 1 year after the baseline questionnaires, then every 6 months during endocrine therapy/other treatments/follow-up until 5 yrs from baseline

• Quality of Life (EORTC QLQ-C30, EORTC-BR42)

  baseline, at the end of chemotherapy/endocrine therapy (if applicable), after surgery, 6 months after surgery, 1 year after the baseline questionnaires, then every 6 months during endocrine therapy/other treatments/follow-up until 5 yrs from baseline

Study Arms (8)

Cohort 1

patients that received surgery without any further anticancer treatment

Other: Questionnaires

Cohort 2

patients that received surgery followed by adjuvant chemotherapy only

Other: Questionnaires

Cohort 3

patients that received surgery followed by chemotherapy and endocrine therapy

Other: Questionnaires

Cohort 4

patients that received surgery followed by endocrine therapy

Other: Questionnaires

Cohort 5

patients that received neoadjuvant chemotherapy followed by surgery and no further treatment

Other: Questionnaires

Cohort 6

patients that received neoadjuvant chemotherapy followed by surgery and adjuvant chemotherapy

Other: Questionnaires

Cohort 7

patients that received neoadjuvant chemotherapy followed by surgery and adjuvant endocrine therapy

Other: Questionnaires

Cohort 8

patients that received neoadjuvant endocrine therapy followed by surgery and adjuvant endocrine therapy

Other: Questionnaires

Interventions

Questionnaires OTHER

The PROFFIT questionnaire is a PRO instrument composed by 16 items encompassing all the major life domains where FT can be expressed and is formed by two type of items: (1) outcome (items 1-7) and (2) determinants (items 8-16). EORTC QLQ-C30, EORTC QLQ-BR42 and HADS questionnaires are currently used in clinical practice

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5; Cohort 6; Cohort 7; Cohort 8

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

early-stage breast cancer patients (see cohorts definition)

You may qualify if:

• Signed informed consent form
• Age \> 18 years at the time of study entry
• Histologically confirmed stage I-III invasive breast carcinoma before starting any systemic treatment.

You may not qualify if:

• Stage IV invasive breast carcinoma
• Major cognitive dysfunction or psychiatric disorders
• Any previous systemic treatment for the current breast cancer

Sponsors & Collaborators

• National Cancer Institute, Naples: lead

Study Sites (1)

National Cancer Institute of Napoli

Naples, Italy

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Financial Stress

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Stress, Psychological; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Maria Carmela Piccirillo, MD

  National Cancer Institute, Naples

  PRINCIPAL INVESTIGATOR

• Martina Pagliuca, MD

  Clinical and Translational Oncology, Scuola Superiore Meridionale, Naples

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Lucia Iacovino, MD

CONTACT

+3908117770692; marialucia.iacovino@istitutotumori.na.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: January 21, 2026
• Study Start: September 30, 2025
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): September 1, 2034
• Last Updated: January 21, 2026

Record last verified: 2025-11

Locations

IT (1)