PRO for Fighting FT in Ovarian Cancer

Ovarian Cancer Clinical Trial

— MITO45-ProFFiT  

Official title:

Patient-Reported Outcome for Fighting Financial Toxicity in Ovarian Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06032975
• Other study ID #: MITO 45-ProFFiT
• Status: Recruiting
• Start date: October 30, 2023
• Est. completion date: September 1, 2027

Study information

• Verified date: September 2023
• Source: National Cancer Institute, Naples
• Contact: Clorinda Schettino, MD
• Phone: +39 081 - 17770276
• Email: c.schettino[@]istitutotumori.na.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: September 1, 2027
• Est. primary completion date: September 1, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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).

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Other:
• 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

Locations

Country	Name	City	State
Italy	Nation Cancer Institute of Naples, Division of Medical Oncology - Uro-Gynecology Department	Naples

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute, Naples

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Financial Toxicity "PROFFIT financial score"	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).	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	Financial toxicity "Determinants"	The baseline score for determinants (items 8-16) and their change during treatment	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	Changes of PROFFIT financial score	Changes of PROFFIT financial score (items 1-7) from baseline during treatment, will be assessed as secondary endpoints.	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	Quality of Life (QoL)	QoL will be assessed as secondary endpoint using selected QoL items (items 29-30 of the EORTC QLQ-C30 questionnaire, items 55-56 of the EORTC QLQ-OV28 questionnaire) and selected symptoms of the PRO-CTCAE library.	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