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

ConditionOncologic Diseases

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorValerio Nardone

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients older than 18 years of age.

Disqualifiers

Patient refusal to complete the questionnaire.

Trial population

Oncologic patients undergoing radiotherapy

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

PROFFIT
Other intervention
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

Treatment groups

1,000 Participants

are divided into 1 treatment group

Group A: Oncologic patients undergoing radiotherapy1 intervention

Trial outcomes

Primary outcomes

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

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.

Other outcomes

Quality of Life (QoL)

QoL will be assessed using EORTC QLQ-C30 questionnaire and selected symptoms of the PRO-CTCAE library.

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.

Sponsors and contacts

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Valerio Nardone

Lead sponsor

University of Campania Luigi Vanvitelli

Sponsor institution

National Cancer Institute (NCI), Naples

Collaborator

Source ClinicalTrials.gov

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