Oncologic DiseasesFIT-RTNCT07175350
Financial Toxicity (FT) for Radiotherapy (RT) Patients in Italy: a yAIRO (Associazione Italiana Radioterapia e Ocologia Clinica) Multicenter Study
An observational study of Oncologic Diseases, run by Valerio Nardone at 7 sites in Italy.
Trial summary
Non- profit, multicenter, prospective, observational study. The study aims to assess financial toxicity (FT) in patients undergoing radiotherapy for oncological diseases, assessed with a validated questionnaire (Patient Reported Outcome for Fighting FInancial Toxicity-PROFFIT- questionnaire). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oncologic Diseases
- What is being tested?
- PROFFIT
- How many people
- 1,000 participants
- Where
- 7 sitesItaly
- Study dates
- 6 Sep 2024to 1 Jun 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Oncologic patients undergoing radiotherapy
Who may be able to join
- Patients older than 18 years of age.
- Histological diagnosis of malignancy for which the patient requires radiotherapy treatment.
Who cannot join
- Patient refusal to complete the questionnaire.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Italy7 sites, 7 recruiting
- Recruiting
Radioterapia Oncologica - Ospedale Mons. Dimiccoli
Barletta
Alessia Di Rito, MD, 3291548267, aledirito@yahoo.it
- Recruiting
Unità di Radioterapia - Responsible Research Hospital
Campobasso, 80017
Donato Pezzulla, MD, 3382630759, donato.pezzulla@responsible.hospital
- Recruiting
Radioterapia oncologica - Ospedale "Vito Fazzi" -
Lecce
Bianca Santo, MD, 3296498618, biancasanto.90@gmail.com
- Recruiting
AOU "L. Vanvitelli" - UOC Radioterapia
Naples, 80131
Roberta Grassi, MD, 3333385815, grassi.roberta89@gmail.com
- Recruiting
.C. Radioterapia - INT G. Pascale
Naples
Sara Falivene, MD, 08117770549, sara.falivene@istitutotumori.na.it
- Recruiting
Radioterapia Oncologica, IRCCS-CROB
Potenza, 85028
Ilaria Benevento, MD, 3922392782, ilaria.benevento@crob.it
- Recruiting
UOC Radioterapia - Fondazione Policlinico A. Gemelli
Roma
Luca Boldrini, MD, 0630155339, luca.boldrini@policlinicogemelli.it
About this study
Official title: Valutazione Della "Financial Toxicity" Nei Pazienti Sottoposti a Radioterapia: Uno Studio Multicentrico Italiano Promosso da yAIRO (Associazione Italiana Radioterapia e Ocologia Clinica)
Non- profit, multicenter, prospective, observational study. The study aims to assess financial toxicity (FT) in patients undergoing radiotherapy for oncological diseases, assessed with a validated questionnaire (Patient Reported Outcome for Fighting FInancial Toxicity-PROFFIT- questionnaire).
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. The primary objective of the study is to assess FT in patients undergoing radiotherapy for oncological diseases and compare FT in different patients group defined according to baseline characteristics (oncologic disease, type of radiotherapy and treatment, age and sex).
Primary comparison will be based on PROFFIT questionnaire fulfilled at baseline (before starting radiotherapy), at the end of RT treatment, at first follow-up visit (1-2 months after the end of RT).
Exploratory analyses will be conducted to verify whether changes in the FT score during treatment are correlated with QOL (EORTC QLQ-C30 questionnaire), toxicity (PRO-CTCAE), and overall survival.
- Conditions
- Oncologic Diseases
- Being tested
- PROFFIT
- Keywords
- Oncologic Diseases, Radiotherapy, Financial toxicity, PROFFIT questionnaire, Quality of Life
- Medical subject headings
- Financial Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROFFITOther
Also called EORTC QLQ-C30 questionnaire, PRO-CTCAE
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 questionnaire is a 30-item questionnaire that measures health-related quality of life (HRQOL) in cancer patients ; PRO-CTCAE is a short list of 43 symptoms relevant for ovarian cancer
| Study group | Role | What they receive |
|---|---|---|
| Oncologic patients undergoing radiotherapy | Not described Receives: Other: PROFFIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Financial toxicity (PROFFIT financial score and "determinants")
PROFFIT financial score is defined according to items 1-7 of the PROFFIT questionnaire. It will be calculated according to published rules (Riva S, et al. BMJ Open. 2019 Sep;9(9):e031485). The baseline score for determinants (items 8-16) and their change during treatment
Measured: baseline (before starting RT), periprocedural (end of radiotherapy treatment, average of 1-2 months); 1-2 months after the end of RT(first follow-up visit) up to 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start6 Sep 2024
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oncologic DiseasesStudies 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Valerio Nardone
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute, Naples
- Responsible party
- Sponsor-investigator, Valerio Nardone, University of Campania Luigi Vanvitelli
- Investigators
- Roberta Grassi, MD, Principal investigator, AOU "L. Vanvitelli" - UOC Radioterapia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07175350
- Sponsor's protocol ID
- FIT-RT
- Acronym
- FIT-RT
- Status last verified
- Sep 2025
- First submitted
- 1 Aug 2025
- Last updated
- 16 Sep 2025
- 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 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Valutazione Della "Financial Toxicity" Nei Pazienti Sottoposti a Radioterapia: Uno Studio Multicentrico Italiano Promosso da yAIRO (Associazione Italiana Radioterapia e Ocologia Clinica)
- ClinicalTrials.gov ID
- NCT07175350
- Acronym / sponsor ID
- FIT-RT / FIT-RT
- Conditions
- Oncologic Diseases
- Keywords
- Oncologic Diseases, Radiotherapy, Financial toxicity, PROFFIT questionnaire, Quality of Life
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Valerio NardoneUniversity, hospital or other
- Collaborators
- National Cancer Institute, Naples
- Study start
- 6 Sep 2024 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 16 Sep 2025 (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. The study aims to assess financial toxicity (FT) in patients undergoing radiotherapy for oncological diseases, assessed with a validated questionnaire (Patient Reported Outcome for Fighting FInancial Toxicity-PROFFIT- questionnaire).
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. The primary objective of the study is to assess FT in patients undergoing radiotherapy for oncological diseases and compare FT in different patients group defined according to baseline characteristics (oncologic disease, type of radiotherapy and treatment, age and sex).
Primary comparison will be based on PROFFIT questionnaire fulfilled at baseline (before starting radiotherapy), at the end of RT treatment, at first follow-up visit (1-2 months after the end of RT).
Exploratory analyses will be conducted to verify whether changes in the FT score during treatment are correlated with QOL (EORTC QLQ-C30 questionnaire), toxicity (PRO-CTCAE), and overall survival.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oncologic patients undergoing radiotherapy | – | Other: PROFFIT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Oncologic patients undergoing radiotherapy
Key inclusion criteria (2 listed)
- Patients older than 18 years of age.
- Histological diagnosis of malignancy for which the patient requires radiotherapy treatment.
Key exclusion criteria (1 listed)
- Patient refusal to complete the questionnaire.
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 |
|---|---|---|
| PROFFITAlso: EORTC QLQ-C30 questionnaire, PRO-CTCAEThe 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 questionnaire is a 30-item questionnaire that measures health-related quality of life (HRQOL) in cancer patients ; PRO-CTCAE is a short list of 43 symptoms relevant for ovarian cancer | Other | Oncologic patients undergoing radiotherapy |
Primary outcome
Financial toxicity (PROFFIT financial score and "determinants")
Time frame: baseline (before starting RT), periprocedural (end of radiotherapy treatment, average of 1-2 months); 1-2 months after the end of RT(first follow-up visit) up to 12 months.
PROFFIT financial score is defined according to items 1-7 of the PROFFIT questionnaire. It will be calculated according to published rules (Riva S, et al. BMJ Open. 2019 Sep;9(9):e031485). The baseline score for determinants (items 8-16) and their change during treatment
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 16 Sep 2025.
- 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.
Roberta Grassi, MD principal investigator
AOU "L. Vanvitelli" - UOC Radioterapia
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oncologic Diseases, run by Valerio Nardone at 7 sites 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 2 inclusion and 1 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 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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 Roberta Grassi, MD (3333385815, grassi.roberta89@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Financial toxicity (PROFFIT financial score and "determinants") (time frame: baseline (before starting RT), periprocedural (end of radiotherapy treatment, average of 1-2 months); 1-2 months after the end of RT(first follow-up visit) up to 12 months.). 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 16 Sep 2025; AzTrials last refreshed its copy on 8 Nov 2026.