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NCT Number: NCT07354165

Financial Toxicity in Patients With Early-stage Breast Cancer

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

PROFFIT questionnaire is an Italian instrument for evaluating FT in cancer patients in the Italian healthcare context. It includes 16 total items, 7 measuring FT (defining the PROFFIT financial score) and 9 measuring possible determinants of FT. Primary aim of this study is to describe 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. In addition, among secondary aims of this study, we aim to verify whether FT is associated with quality of life response , and with disease free survival and overall survival.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

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

Primary outcomes

  1. Financial Toxicity at one year

    Time frame: 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

    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

Secondary outcomes

  1. Changes in PROFFIT scores

    Time frame: 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

    baseline PROFFIT-score and its trajectory at subsequent time points across different cohorts and in the whole study sample.

    The Patient Reported Outcome for Fighting FInancial Toxicity (PROFFIT) questionnaire is a PRO instrument composed by 16 items encompassing all the major life domains where financial toxicity can be expressed and consist of two type of items: a) outcome (items 1-7) and b) determinants (items 8-16). PROFFIT financial score is defined according to items 1-7 of the PROFFIT questionnaire, range 0-100, 100 indicating maximum financial toxicity.

  2. Financial toxicity "Determinants"

    Time frame: 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

    the individual PROFFIT items (items 8-16 representing potential determinants of financial distress) at baseline and subsequent time points.

    The Patient Reported Outcome for Fighting FInancial Toxicity (PROFFIT) questionnaire is a PRO instrument composed by 16 items encompassing all the major life domains where financial toxicity can be expressed and consist of two type of items: a) outcome (items 1-7) and b) determinants (items 8-16). PROFFIT financial score is defined according to items 1-7 of the PROFFIT questionnaire, range 0-100, 100 indicating maximum financial toxicity.

  3. PROFFIT score and survival

    Time frame: 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

    the prognostic role of baseline PROFFIT-score in terms of disease-free survival (DFS), as well as overall survival (OS).

    The Patient Reported Outcome for Fighting FInancial Toxicity (PROFFIT) questionnaire is a PRO instrument composed by 16 items encompassing all the major life domains where financial toxicity can be expressed and consist of two type of items: a) outcome (items 1-7) and b) determinants (items 8-16). PROFFIT financial score is defined according to items 1-7 of the PROFFIT questionnaire, range 0-100, 100 indicating maximum financial toxicity.

  4. Quality of Life (EORTC QLQ-C30, EORTC-BR42)

    Time frame: 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

    The prognostic role of baseline PROFFIT-score in terms of QoL outcomes. The Patient Reported Outcome for Fighting FInancial Toxicity (PROFFIT) questionnaire is a PRO instrument composed by 16 items encompassing all the major life domains where financial toxicity can be expressed and consist of two type of items: a) outcome (items 1-7) and b) determinants (items 8-16). PROFFIT financial score is defined according to items 1-7 of the PROFFIT questionnaire, range 0-100, 100 indicating maximum financial toxicity.

    EORTC QLQ-C30 scores calculated according to the EORTC QLQ-C30 Scoring Manual; HRQL score calculated by averaging the responses to the items 29 and 30 of the EORTC QLQ-C30; EORTC QLQ-BR42 scores calculated according to the EORTC QLQ-BR42 Scoring Manual.

Study contacts

Contact information is provided by the study sponsor or research team.

Maria Lucia Iacovino, MD

CONTACT

[email protected]

+3908117770692

Sponsors and collaborators

Lead sponsor

National Cancer Institute, Naples

Other

Registry information

Official study title

Assessing Prevalence of Financial Burden and Impact of Cancer on Financial toxicIty in Patients With Early-stage Breast Cancer

Acronym: VOICE - GIM36

Important dates

Study start
2025
Primary completion
2030
Study completion
2034
First posted
Jan 21, 2026
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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