Clinical trial NCT06032975: PRO for Fighting FT in Ovarian Cancer
Official title: Patient-Reported Outcome for Fighting Financial Toxicity in Ovarian Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ovarian Cancer
Keywords: Ovarian cancer
Financial Toxicity
Quality of life
PROFFIT questionnaire
PRO-CTCAE
Lead sponsor: National Cancer Institute, Naples
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 240
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with OC candidate to medical treatment (see cohorts definition).

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Financial Toxicity "PROFFIT financial score"
timeFrame: 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
Secondary outcomes:
measure: Financial toxicity "Determinants"
timeFrame: 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.
measure: Changes of PROFFIT financial score
timeFrame: 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
measure: Quality of Life (QoL)
timeFrame: 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
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Nation Cancer Institute of Naples, Division of Medical Oncology - Uro-Gynecology Department
Study officials:
affiliation: National Cancer Institute, Naples
name: Sandro Pignata, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: