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| Name | Class |
|---|---|
| National Cancer Institute, Naples | OTHER |
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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).
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).
Primary 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).
Exploratory 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oncologic patients undergoing radiotherapy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life (QoL) | QoL will be assessed using EORTC QLQ-C30 questionnaire and selected symptoms of the PRO-CTCAE library. | 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. |
Inclusion Criteria:
Histological diagnosis of malignancy for which the patient requires radiotherapy treatment.
Exclusion Criteria:
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Oncologic patients undergoing radiotherapy
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Roberta Grassi, MD | Contact | 3333385815 | grassi.roberta89@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Roberta Grassi, MD | AOU "L. Vanvitelli" - UOC Radioterapia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radioterapia Oncologica - Ospedale Mons. Dimiccoli | Recruiting | Barletta | Italy |
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| Unità di Radioterapia - Responsible Research Hospital | Recruiting | Campobasso | 80017 | Italy |
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| Radioterapia oncologica - Ospedale "Vito Fazzi" - | Recruiting | Lecce | Italy |
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| AOU "L. Vanvitelli" - UOC Radioterapia | Recruiting | Naples | 80131 | Italy |
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| .C. Radioterapia - INT G. Pascale | Recruiting | Naples | Italy |
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| Radioterapia Oncologica, IRCCS-CROB | Recruiting | Potenza | 85028 | Italy |
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| UOC Radioterapia - Fondazione Policlinico A. Gemelli | Recruiting | Roma | Italy |
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| ID | Term |
|---|---|
| D000086522 | Financial Stress |
| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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