Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06032975

PRO for Fighting FT in Ovarian Cancer

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Ovarian Cancer Adnexal Diseases Behavior Behavioral Symptoms Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Financial Stress Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Stress, Psychological Urogenital Diseases Urogenital Neoplasms

Sex eligibility

Female

Study type

Observational

Primary location

Nation Cancer Institute of Naples, Division of Medical Oncology - Uro-Gynecology Department

Naples, Italy

Location status: Recruiting

Location contact

Sandro Pignata, MD, PhD

CONTACT

[email protected]

+39 081-17770755

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

questionnaires

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

Other names: Questionnaires: PROFFIT, EORTC QLQ-C30 questionnaire (items 29-30), EORTC OV28 (items 55-58), PRO-CTCAE

Primary outcomes

  1. Financial Toxicity "PROFFIT financial score"

    Time frame: 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

    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).

Secondary outcomes

  1. Financial toxicity "Determinants"

    Time frame: 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.

    The baseline score for determinants (items 8-16) and their change during treatment

  2. Changes of PROFFIT financial score

    Time frame: 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 (items 1-7) from baseline during treatment, will be assessed as secondary endpoints.

  3. Quality of Life (QoL)

    Time frame: 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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Clorinda Schettino, MD

CONTACT

[email protected]

+39 081 - 17770276

Piera Gargiulo, MD

CONTACT

[email protected]

+39 081 - 17770276

Sponsors and collaborators

Lead sponsor

National Cancer Institute, Naples

Other

Registry information

Official study title

Patient-Reported Outcome for Fighting Financial Toxicity in Ovarian Cancer

Acronym: MITO45-ProFFiT

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Sep 13, 2023
Registry last updated
Nov 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.