Financial Toxicity in Patients With Early-stage Breast Cancer
ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorNational Cancer Institute, Naples
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Stage IV invasive breast carcinoma
Major cognitive dysfunction or psychiatric disorders
Any previous systemic treatment for the current breast cancer
Trial population
early-stage breast cancer patients (see cohorts definition)
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Questionnaires
Other interventionThe 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
Treatment groups
864 Participants
are divided into 8 treatment groups8
Treatment groupsSee each treatment group below.
Group A: Cohort 11 intervention
Group B: Cohort 21 intervention
Group C: Cohort 31 intervention
Group D: Cohort 41 intervention
Group E: Cohort 51 intervention
Group F: Cohort 61 intervention
Group G: Cohort 71 intervention
Group H: Cohort 81 intervention
Trial outcomes
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
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 questionnairesSecondary outcomes
1
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.
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 baseline2
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.
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 baseline3
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.
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 baseline4
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.
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 baselineSponsors and contacts
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Source ClinicalTrials.gov