## Protocol Section
### Identification Module
**NCT ID:** NCT03473379

**Acronym:** PROFTC-I

**Brief Title:** Development and Validation of a Tool for Patient-reported Assessment of Cancer-related Financial Toxicity in Italy

**Official Title:** Development and Validation of a Tool for Patient-reported Assessment of Cancer-related Financial Toxicity - Italy

#### Organization Study ID Info
**ID:** PROFTC-I
#### Organization
**Class:** OTHER
**Full Name:** National Cancer Institute, Naples
### Status Module
#### Completion Date
**Date:** 2024-07-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-03-24

**Type:** ACTUAL

**Last Update Submit Date:** 2023-03-23

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-02-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2018-03-01

**Type:** ACTUAL

**Status Verified Date:** 2023-03

#### Study First Post Date
**Date:** 2018-03-22
**Type:** ACTUAL
**Study First Submit Date:** 2018-03-15
**Study First Submit QC Date:** 2018-03-15
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** National Cancer Institute, Naples

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** 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.

**Detailed Description:** The project will be conducted according to the methodology delineated by the International Society for Pharmacoeconomics and Outcome Research (ISPOR) Patient Reported Outcomes Content Validity Good Research Practices Task Force in the following phases: concept elicitation and coding, item generation and analysis, instrument refinement and internal validation, and external validation.

### Conditions Module

**Conditions:**

- Cancer

**Keywords:**

- economic difficulty, financial toxicity

### Design Module

#### Design Info

**Observational Model:** OTHER

**Time Perspective:** CROSS_SECTIONAL

#### Enrollment Info

**Count:** 440

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**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 1: concept elicitation and coding

#### Arm Group 2

**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 2: Item generation and analysis

#### Arm Group 3

**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 3: Instrument refinement and internal validation

#### Arm Group 4

**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

**Label:** Phase 4: External validation

### Outcomes Module

#### Primary Outcomes

**Description:** During the development of the questionnaire, individual items (questions), response options, and type of scoring will be determined according to Phases 1-3. Subsequently a principal components analysis (explorative factor analysis) will be done with eigen value set at 1; internal reliability will be assessed by inter-item correlations and Cronbach's alpha ( minimum acceptable 0.70); intraclass correlation coefficient (minimum acceptable 0.80). Correlation of final instrument with the EORTC quality of life questionnaire (criterion validity) will be assessed with using Pearson correlation coefficient.

**Measure:** Validation of Patient reported outcome financial toxicity of cancer Italian(PROFTC-I) questionnaire

**Time Frame:** 48 months

### Eligibility Module

**Eligibility Criteria:** 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

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Patients with any type of solid cancer or haematological malignancy who has undergone medical treatment, including chemotherapy, target agents, immunotherapy, hormonal treatment, radiotherapy and combinations of such therapies, or their caregivers, will be recruited in northern, central and southern Italian hospitals..

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** f.perrone@istitutotumori.na.it

**Name:** Francesco Perrone

**Phone:** 0815903571

**Role:** CONTACT

**Contact 2:**

**Email:** j.bryce@istitutotumori.na.it

**Name:** Jane Bryce

**Phone:** 0815903571

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Napoli

**Country:** Italy

**Facility:** Azienda dei Colli

**Status:** RECRUITING

**Location 2:**

**City:** Napoli

**Country:** Italy

**Facility:** Istituto Nazionale Tumori, IRCCS Fondazione Pascale

**Status:** RECRUITING

**Location 3:**

**City:** Roma

**Country:** Italy

**Facility:** Istituto Nazionale Tumori Regina Elena - IRCCS - IFO

**Status:** RECRUITING

**Location 4:**

**City:** Roma

**Country:** Italy

**Facility:** Policlinico Universitario Campus Biomedico

**Status:** NOT_YET_RECRUITING

**Location 5:**

**City:** Torino

**Country:** Italy

**Facility:** AO Ordine Mauriziano

**Status:** RECRUITING

#### Overall Officials

**Official 1:**

**Affiliation:** Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale

**Name:** Francesco Perrone

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale

**Name:** Jane Bryce

**Role:** PRINCIPAL_INVESTIGATOR

**Official 3:**

**Affiliation:** Università degli Studi della Campania Luigi Vanvitelli

**Name:** Ciro Gallo

**Role:** PRINCIPAL_INVESTIGATOR

**Official 4:**

**Affiliation:** St. Mary University, Twickenham, London, GB

**Name:** Silvia Riva

**Role:** PRINCIPAL_INVESTIGATOR

**Official 5:**

**Affiliation:** Northwestern University, Feinberg School of Medicine, GIMEMA,EORTC Quality of Life Group - Rappresentante GIMEMA

**Name:** Fabio Efficace

**Role:** PRINCIPAL_INVESTIGATOR

**Official 6:**

**Affiliation:** AIMAC and European Cancer Patient Coalition

**Name:** Francesco De Lorenzo

**Role:** PRINCIPAL_INVESTIGATOR

**Official 7:**

**Affiliation:** Segretario Generale FAVO

**Name:** Elisabetta Iannelli

**Role:** PRINCIPAL_INVESTIGATOR

**Official 8:**

**Affiliation:** FAVO

**Name:** Laura Del Campo

**Role:** PRINCIPAL_INVESTIGATOR

**Official 9:**

**Affiliation:** AIMAC

**Name:** Francesca Traclò

**Role:** PRINCIPAL_INVESTIGATOR

**Official 10:**

**Affiliation:** AO Ordine Mauriziano

**Name:** Massimo Di Maio

**Role:** PRINCIPAL_INVESTIGATOR

**Official 11:**

**Affiliation:** Federation of Italian Cooperative Oncology Groups

**Name:** Luciano Frontini

**Role:** PRINCIPAL_INVESTIGATOR

**Official 12:**

**Affiliation:** Oncologia, Azienda dei Colli, Napoli - CIPOMO

**Name:** Vincenzo Montesarchio

**Role:** PRINCIPAL_INVESTIGATOR

**Official 13:**

**Affiliation:** Centro per gli Studi Economici e Internazionali - Economic Evaluation & Health Technology Assessment (CEIS EEHTA), Università di Roma "Tor Vergata"

**Name:** Lara Gitto

**Role:** PRINCIPAL_INVESTIGATOR

**Official 14:**

**Affiliation:** Dipartimento di Scienze del Farmaco, Università del Piemonte Orientale; Osservatorio Farmaci, Cergas, SDA Bocconi

**Name:** Claudio Jommi

**Role:** PRINCIPAL_INVESTIGATOR

**Official 15:**

**Affiliation:** Welfare e Salute CENSIS (Centro Studi Investimenti Sociali), Roma

**Name:** Concetta Maria Vaccaro

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

### References Module

#### References

**Citation:** Riva 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

**Citation:** Riva 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

**Citation:** Riva 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

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000013315

- Term: Stress, Psychological

- ID: D000001526

- Term: Behavioral Symptoms

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M2567

- Name: Financial Stress

- Relevance: HIGH

- As Found: Financial Toxicity

- ID: M16105

- Name: Stress, Psychological

- Relevance: LOW

- As Found: Unknown

- ID: M4818

- Name: Behavioral Symptoms

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000086522

- Term: Financial Stress

### Misc Info Module

- Version Holder: 2024-05-24
