Clinical trial · Observational
Development and Validation of a Tool for Patient-reported Assessment of Cancer-related Financial Toxicity in Italy
Development and Validation of a Tool for Patient-reported Assessment of Cancer-related Financial Toxicity - Italy
NCT03473379CI-TRIAL-00064955PROFTC-IunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of this study is to develop and validate a patient-reported-outcome instrument (PROFTC-I: Patient Reported Outcome Financial Toxicity in Cancer - Italy) able to describe and measure financial problems of Italian patients receiving cancer treatment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (4)
- label
- Phase 1: concept elicitation and coding
- description
- The aim of this phase is to elicit concepts from patients, caregivers, and oncology clinicians through focus groups of patients and caregivers, qualitative interviews and surveys. Approximately 55 patients or caregivers will participate in this phase.
- label
- Phase 2: Item generation and analysis
- description
- The aim of this phase is produce a draft version of the questionnaire. Approximately 90 patients or caregivers will be recruited in this phase for item ranking and analysis through questionnaire evaluation and cognitive interviews.
- label
- Phase 3: Instrument refinement and internal validation
- description
- The aim of this phase is generate the final version of the instrument. Approximately 101 patients or caregivers will participate in this phase by completing the questionnaire
- label
- Phase 4: External validation
- description
- In this phase the questionnaire will undergo further psychometric testing for validation and approximately 220 patients or caregivers will be asked to complete the PROFTC-I questionnaire along with quality of life instruments
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients (\>18 years) * Histologically or cytologically confirmed diagnosis of any type of solid cancer or haematological malignancy * Written Informed Consent provided * Medical treatment (chemotherapy, target agents, immunotherapy, hormonal treatment, radiotherapy or combinations of such therapies) ongoing or terminated within the previous 3 months. * Caregivers of patients who meet the above criteria Exclusion Criteria: * Patients with major cognitive dysfunction or psychiatric disorders * Patients who have never received anticancer medical or radiation treatment
References
Publications (3)
- DERIVEDRiva S, Arenare L, Di Maio M, Efficace F, Montesarchio V, Frontini L, Giannarelli D, Bryce J, Del Campo L, De Lorenzo F, Iannelli E, Traclo F, Gitto L, Jommi C, Vaccaro CM, Barberio D, Cinieri S, Porta C, Del Mastro L, Zagonel V, Cogoni AA, Bordonaro R, Gimigliano A, Piccirillo MC, Guizzaro L, Gallo C, Perrone F. Cross-sectional study to develop and describe psychometric characteristics of a patient-reported instrument (PROFFIT) for measuring financial toxicity of cancer within a public healthcare system. BMJ Open. 2021 Oct 20;11(10):e049128. doi: 10.1136/bmjopen-2021-049128. PMID 34670762
- DERIVEDRiva S, Efficace F, Di Maio M, Bryce J, Del Campo L, De Lorenzo F, Frontini L, Giannarelli D, Gitto L, Iannelli E, Jommi C, Montesarchio V, Traclo F, Vaccaro CM, Arenare L, Canzanella G, Gimigliano A, Romano F, Savio A, Sparavigna L, Piccirillo MC, Guizzaro L, Gallo C, Perrone F. A qualitative analysis and development of a conceptual model assessing financial toxicity in cancer patients accessing the universal healthcare system. Support Care Cancer. 2021 Jun;29(6):3219-3233. doi: 10.1007/s00520-020-05840-z. Epub 2020 Oct 22. PMID 33094357
- DERIVEDRiva S, Bryce J, De Lorenzo F, Del Campo L, Di Maio M, Efficace F, Frontini L, Giannarelli D, Gitto L, Iannelli E, Jommi C, Montesarchio V, Traclo F, Vaccaro CM, Gallo C, Perrone F. Development and validation of a patient-reported outcome tool to assess cancer-related financial toxicity in Italy: a protocol. BMJ Open. 2019 Sep 9;9(9):e031485. doi: 10.1136/bmjopen-2019-031485. PMID 31501130