Breast CancerVOICE - GIM36NCT07354165
Financial Toxicity in Patients With Early-stage Breast Cancer
An observational study of Breast Cancer, run by National Cancer Institute, Naples at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Questionnaires
- How many people
- 864 participants
- Where
- 1 siteItaly
- Study dates
- 30 Sep 2025to Sep 2034
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: early-stage breast cancer patients (see cohorts definition)
Who may be able to join
- 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.
Who cannot join
- Stage IV invasive breast carcinoma
- Major cognitive dysfunction or psychiatric disorders
- Any previous systemic treatment for the current breast cancer
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
National Cancer Institute of Napoli
Naples
Maria Carmela Piccirillo, MD, +39 081-1777 0280, m.piccirillo@istitutotumori.na.it
About this study
Official title: Assessing Prevalence of Financial Burden and Impact of Cancer on 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.
Read the detailed description
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.
- Conditions
- Breast Cancer
- Being tested
- Questionnaires
- Keywords
- early breast cancer, financial toxicity, quality of life, PROFFIT questionnaire
- Medical subject headings
- Breast Neoplasms, Financial Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
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
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | patients that received surgery without any further anticancer treatment Receives: Other: Questionnaires | |
| Cohort 2 | patients that received surgery followed by adjuvant chemotherapy only Receives: Other: Questionnaires | |
| Cohort 3 | patients that received surgery followed by chemotherapy and endocrine therapy Receives: Other: Questionnaires | |
| Cohort 4 | patients that received surgery followed by endocrine therapy Receives: Other: Questionnaires | |
| Cohort 5 | patients that received neoadjuvant chemotherapy followed by surgery and no further treatment Receives: Other: Questionnaires | |
| Cohort 6 | patients that received neoadjuvant chemotherapy followed by surgery and adjuvant chemotherapy Receives: Other: Questionnaires | |
| Cohort 7 | patients that received neoadjuvant chemotherapy followed by surgery and adjuvant endocrine therapy Receives: Other: Questionnaires | |
| Cohort 8 | patients that received neoadjuvant endocrine therapy followed by surgery and adjuvant endocrine therapy Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start30 Sep 2025
- Primary completionSep 2030 (estimated)
- Study completionSep 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 864 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Naples
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Carmela Piccirillo, MD, Principal investigator, National Cancer Institute, NaplesMartina Pagliuca, MD, Principal investigator, Clinical and Translational Oncology, Scuola Superiore Meridionale, Naples
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07354165
- Sponsor's protocol ID
- VOICE - GIM36
- Acronym
- VOICE - GIM36
- Status last verified
- Nov 2025
- First submitted
- 25 Nov 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Prevalence of Financial Burden and Impact of Cancer on Financial toxicIty in Patients With Early-stage Breast Cancer
- ClinicalTrials.gov ID
- NCT07354165
- Acronym / sponsor ID
- VOICE - GIM36 / VOICE - GIM36
- Conditions
- Breast Cancer
- Keywords
- early breast cancer, financial toxicity, quality of life, PROFFIT questionnaire
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 864 participants (estimated)
- Lead sponsor
- National Cancer Institute, NaplesUniversity, hospital or other
- Study start
- 30 Sep 2025 (actual)
- Primary completion
- Sep 2030 (estimated)
- Study completion
- Sep 2034 (estimated)
- First posted
- 21 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Other: Questionnairespatients that received surgery without any further anticancer treatment |
| Cohort 2 | – | Other: Questionnairespatients that received surgery followed by adjuvant chemotherapy only |
| Cohort 3 | – | Other: Questionnairespatients that received surgery followed by chemotherapy and endocrine therapy |
| Cohort 4 | – | Other: Questionnairespatients that received surgery followed by endocrine therapy |
| Cohort 5 | – | Other: Questionnairespatients that received neoadjuvant chemotherapy followed by surgery and no further treatment |
| Cohort 6 | – | Other: Questionnairespatients that received neoadjuvant chemotherapy followed by surgery and adjuvant chemotherapy |
| Cohort 7 | – | Other: Questionnairespatients that received neoadjuvant chemotherapy followed by surgery and adjuvant endocrine therapy |
| Cohort 8 | – | Other: Questionnairespatients that received neoadjuvant endocrine therapy followed by surgery and adjuvant endocrine therapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- early-stage breast cancer patients (see cohorts definition)
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Stage IV invasive breast carcinoma
- Major cognitive dysfunction or psychiatric disorders
- Any previous systemic treatment for the current breast cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesThe 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 | Other | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6, Cohort 7, Cohort 8 |
Primary outcome
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
4 secondary outcomes
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maria Carmela Piccirillo, MD principal investigator
National Cancer Institute, Naples
Martina Pagliuca, MD principal investigator
Clinical and Translational Oncology, Scuola Superiore Meridionale, Naples
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by National Cancer Institute, Naples at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria Lucia Iacovino, MD (+3908117770692, marialucia.iacovino@istitutotumori.na.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.