Financial Toxicity (FT) for Radiotherapy (RT) Patients in Italy: a yAIRO (Associazione Italiana Radioterapia e Ocologia Clinica) Multicenter Study

NCT07175350 | Recruiting

• 1 other identifier: FIT-RT
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 7

Brief 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).

Conditions

Oncologic Diseases

Keywords

Oncologic Diseases; Radiotherapy; Financial toxicity; PROFFIT questionnaire; Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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

  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.

Other Outcomes (1)

• Quality of Life (QoL)

  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.

Study Arms (1)

Oncologic patients undergoing radiotherapy

Other: PROFFIT

Interventions

PROFFIT 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 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

Also known as: EORTC QLQ-C30 questionnaire, PRO-CTCAE

Oncologic patients undergoing radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Oncologic patients undergoing radiotherapy

You may qualify if:

• Patients older than 18 years of age.
• Histological diagnosis of malignancy for which the patient requires radiotherapy treatment.

You may not qualify if:

• Patient refusal to complete the questionnaire.

Sponsors & Collaborators

• Valerio Nardone: lead
• National Cancer Institute (NCI), Naples: collaborator

Study Sites (7)

Radioterapia Oncologica - Ospedale Mons. Dimiccoli

Barletta, Italy

RECRUITING

Unità di Radioterapia - Responsible Research Hospital

Campobasso, 80017, Italy

RECRUITING

Radioterapia oncologica - Ospedale "Vito Fazzi" -

Lecce, Italy

RECRUITING

AOU "L. Vanvitelli" - UOC Radioterapia

Napoli, 80131, Italy

RECRUITING

.C. Radioterapia - INT G. Pascale

Napoli, Italy

RECRUITING

Radioterapia Oncologica, IRCCS-CROB

Potenza, 85028, Italy

RECRUITING

UOC Radioterapia - Fondazione Policlinico A. Gemelli

Roma, Italy

RECRUITING

MeSH Terms

Conditions

Financial Stress

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Roberta Grassi, MD

  AOU "L. Vanvitelli" - UOC Radioterapia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roberta Grassi, MD

CONTACT

3333385815; grassi.roberta89@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: August 1, 2025
• First Posted: September 16, 2025
• Study Start: September 6, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: September 16, 2025

Record last verified: 2025-09

Locations

IT (7)