Ignite Creation Date:
2025-12-24 @ 4:57 PM
Ignite Modification Date:
2025-12-25 @ 2:39 PM
Study NCT ID:
NCT07175350
Status:
RECRUITING
Last Update Posted:
2025-09-16
First Post:
2025-08-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Financial Toxicity (FT) for Radiotherapy (RT) Patients in Italy: a yAIRO (Associazione Italiana Radioterapia e Ocologia Clinica) Multicenter Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086522', 'term': 'Financial Stress'}], 'ancestors': [{'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-15', 'studyFirstSubmitDate': '2025-08-01', 'studyFirstSubmitQcDate': '2025-09-15', 'lastUpdatePostDateStruct': {'date': '2025-09-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Quality of Life (QoL)', 'timeFrame': '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.', 'description': 'QoL will be assessed using EORTC QLQ-C30 questionnaire and selected symptoms of the PRO-CTCAE library.'}], 'primaryOutcomes': [{'measure': 'Financial toxicity (PROFFIT financial score and "determinants")', 'timeFrame': '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.', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Oncologic Diseases', 'Radiotherapy', 'Financial toxicity', 'PROFFIT questionnaire', 'Quality of Life'], 'conditions': ['Oncologic Diseases']}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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).\n\nPrimary 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).\n\nExploratory 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Oncologic patients undergoing radiotherapy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients older than 18 years of age.\n\nHistological diagnosis of malignancy for which the patient requires radiotherapy treatment.\n\nExclusion Criteria:\n\n* Patient refusal to complete the questionnaire.'}, 'identificationModule': {'nctId': 'NCT07175350', 'acronym': 'FIT-RT', 'briefTitle': 'Financial Toxicity (FT) for Radiotherapy (RT) Patients in Italy: a yAIRO (Associazione Italiana Radioterapia e Ocologia Clinica) Multicenter Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Campania Luigi Vanvitelli'}, 'officialTitle': 'Valutazione Della "Financial Toxicity" Nei Pazienti Sottoposti a Radioterapia: Uno Studio Multicentrico Italiano Promosso da yAIRO (Associazione Italiana Radioterapia e Ocologia Clinica)', 'orgStudyIdInfo': {'id': 'FIT-RT'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Oncologic patients undergoing radiotherapy', 'interventionNames': ['Other: PROFFIT']}], 'interventions': [{'name': 'PROFFIT', 'type': 'OTHER', 'otherNames': ['EORTC QLQ-C30 questionnaire', 'PRO-CTCAE'], 'description': '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', 'armGroupLabels': ['Oncologic patients undergoing radiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Barletta', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Alessia Di Rito, MD', 'role': 'CONTACT', 'email': 'aledirito@yahoo.it', 'phone': '3291548267'}], 'facility': 'Radioterapia Oncologica - Ospedale Mons. Dimiccoli', 'geoPoint': {'lat': 41.31429, 'lon': 16.28165}}, {'zip': '80017', 'city': 'Campobasso', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Donato Pezzulla, MD', 'role': 'CONTACT', 'email': 'donato.pezzulla@responsible.hospital', 'phone': '3382630759'}], 'facility': 'Unità di Radioterapia - Responsible Research Hospital', 'geoPoint': {'lat': 41.55947, 'lon': 14.66737}}, {'city': 'Lecce', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Bianca Santo, MD', 'role': 'CONTACT', 'email': 'biancasanto.90@gmail.com', 'phone': '3296498618'}], 'facility': 'Radioterapia oncologica - Ospedale "Vito Fazzi" -', 'geoPoint': {'lat': 40.35481, 'lon': 18.17244}}, {'zip': '80131', 'city': 'Napoli', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Roberta Grassi, MD', 'role': 'CONTACT', 'email': 'grassi.roberta89@gmail.com', 'phone': '3333385815'}], 'facility': 'AOU "L. Vanvitelli" - UOC Radioterapia', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'city': 'Napoli', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Sara Falivene, MD', 'role': 'CONTACT', 'email': 'sara.falivene@istitutotumori.na.it', 'phone': '08117770549'}], 'facility': '.C. Radioterapia - INT G. Pascale', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'zip': '85028', 'city': 'Potenza', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Ilaria Benevento, MD', 'role': 'CONTACT', 'email': 'ilaria.benevento@crob.it', 'phone': '3922392782'}], 'facility': 'Radioterapia Oncologica, IRCCS-CROB', 'geoPoint': {'lat': 40.64175, 'lon': 15.80794}}, {'city': 'Roma', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Luca Boldrini, MD', 'role': 'CONTACT', 'email': 'luca.boldrini@policlinicogemelli.it', 'phone': '0630155339'}], 'facility': 'UOC Radioterapia - Fondazione Policlinico A. Gemelli', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}], 'centralContacts': [{'name': 'Roberta Grassi, MD', 'role': 'CONTACT', 'email': 'grassi.roberta89@gmail.com', 'phone': '3333385815'}], 'overallOfficials': [{'name': 'Roberta Grassi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AOU "L. Vanvitelli" - UOC Radioterapia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Valerio Nardone', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI), Naples', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Valerio Nardone', 'investigatorAffiliation': 'University of Campania Luigi Vanvitelli'}}}}