PRO for Fighting FT in Ovarian Cancer

Официальное название

Patient-Reported Outcome for Fighting Financial Toxicity in Ovarian Cancer

Обзор

Non-profit, multicenter, prospective, observational study. This study aims to evaluate whether the articulated treatment algorithm that is now possible for OC patients does produce tangible changes of financial distress over the time and whether the determinants of financial distress change their relative weight over the time.

Подробное описание

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 aim of the study is to compare PROFFIT financial score (items 1-7 measuring the financial distress) across different lines of treatment for OC patients undergoing anticancer medical treatment. Primary comparison will be based on PROFFIT questionnaire fulfilled at baseline, before starting each line of treatment.

In addition, among secondary aims of this study, we aim to verify whether FT is associated with quality of life response (items 29-30 of the EORTC QLQ-C30 questionnaire and items 55-56 of the EORTC QLQ-OV28 questionnaire), with patient-self reporting toxicity of treatments (selected symptoms of the PRO-CTCAE library response), and with overall survival.

Вмешательства

• Другое Questionnaires
  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 (items 29-30) and OV28 (items 55-58); PRO-CTCAE: short list of 43 symptoms relevant for ovarian cancer

Первичные конечные точки

• Financial Toxicity "PROFFIT financial score" [Срок оценки: baseline visit, at the end of every cycle of treatment (each cycle is 21 or 28 days depending of type of therapy), and at time of progressive disease (PD) per RECIST 1.1 up to 36 months]

Вторичные конечные точки (3)

• Financial toxicity "Determinants" [Срок оценки: baseline visit, at the end of every cycle of treatment (each cycle is 21 or 28 days depending of type of therapy), and at time of progressive disease (PD) per RECIST 1.1 up to 36 months.]
• Changes of PROFFIT financial score [Срок оценки: baseline visit, at the end of every cycle of treatment (each cycle is 21 or 28 days depending of type of therapy), and at time of progressive disease (PD) per RECIST 1.1 up to 36 months]
• Quality of Life (QoL) [Срок оценки: baseline visit, at the end of every cycle of treatment (each cycle is 21 or 28 days depending of type of therapy), and at time of progressive disease (PD) per RECIST 1.1 up to 36 months]

Критерии участия

Критерии включения

• Written informed consent provided;
• Women ≥18 years;
• Histologically or citologically confirmed diagnosis of epithelial ovarian, fallopian tube or peritoneal cancer stage IC-IV according to FIGO staging system;
• Patients who are close to begin any type of medical treatment against ovarian cancer.

Критерии исключения

• Major cognitive dysfunction or psychiatric disorders;
• Patients with epithelial ovarian, fallopian tube or peritoneal cancer candidate exclusively to follow-up;
• Patients who have received more than 4 previous lines of medical treatment (maintenance treatments do not represent a line).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Италия · 1 центр

• Nation Cancer Institute of Naples, Division of Medical Oncology - Uro-Gynecology Departmen — Naples

Идентификаторы

NCT: NCT06032975 · MITO 45-ProFFiT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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