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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | patients that received surgery without any further anticancer treatment |
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| Cohort 2 | patients that received surgery followed by adjuvant chemotherapy only |
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| Cohort 3 | patients that received surgery followed by chemotherapy and endocrine therapy |
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| Cohort 4 | patients that received surgery followed by endocrine therapy |
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| Cohort 5 | patients that received neoadjuvant chemotherapy followed by surgery and no further treatment |
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| Cohort 6 | patients that received neoadjuvant chemotherapy followed by surgery and adjuvant chemotherapy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in PROFFIT scores | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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early-stage breast cancer patients (see cohorts definition)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maria Lucia Iacovino, MD | Contact | +3908117770692 | marialucia.iacovino@istitutotumori.na.it |
| Name | Affiliation | Role |
|---|---|---|
| Maria Carmela Piccirillo, MD | National Cancer Institute, Naples | Principal Investigator |
| Martina Pagliuca, MD | Clinical and Translational Oncology, Scuola Superiore Meridionale, Naples | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Institute of Napoli | Recruiting | Naples | Italy |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D000086522 | Financial Stress |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| Cohort 7 | patients that received neoadjuvant chemotherapy followed by surgery and adjuvant endocrine therapy |
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| Cohort 8 | patients that received neoadjuvant endocrine therapy followed by surgery and adjuvant endocrine therapy |
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| 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" | 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. | 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 | 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. | 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) | 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. | 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 |
| D017437 |
| Skin and Connective Tissue Diseases |
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |