PRO for Fighting FT in Ovarian Cancer

NCT06032975 | Recruiting

• 1 other identifier: MITO 45-ProFFiT
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Cancer

Keywords

Ovarian cancer; Financial Toxicity; Quality of life; PROFFIT questionnaire; PRO-CTCAE

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Financial toxicity "Determinants"

  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

  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)

  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

Study Arms (4)

Cohort 1:

Patients undergoing their first medical treatment for OC (including adjuvant and neo-adjuvant chemotherapy and first-line treatment for advanced in patients not previously treated with adjuvant chemotherapy)

Other: Questionnaires

Cohort 2

Patients undergoing their second medical treatment for OC (including the second-line treatment for advanced disease and the first-line treatment for advanced disease in patients previously treated with adjuvant CT)

Other: Questionnaires

Cohort 3

Patients undergoing their third medical treatment for OC (including the third-line treatment for advanced disease and the second-line treatment for advanced disease in patients previously treated with adjuvant CT)

Other: Questionnaires

Cohort 4

Patients undergoing their fourth medical treatment for OC (including the fourth- treatment for advanced disease and the third-line treatment for advanced disease in patients previously treated with adjuvant CT)

Other: Questionnaires

Interventions

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

Also known as: Questionnaires: PROFFIT, EORTC QLQ-C30 questionnaire (items 29-30), EORTC OV28 (items 55-58), PRO-CTCAE

Cohort 1:; Cohort 2; Cohort 3; Cohort 4

Eligibility Criteria

• Gender Eligibility Details: Ovarian cancer patients
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with OC candidate to medical treatment (see cohorts definition).

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• National Cancer Institute, Naples: lead

Study Sites (1)

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

Naples, Italy

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms; Financial Stress

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Sandro Pignata, MD, PhD

  National Cancer Institute, Naples

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clorinda Schettino, MD

CONTACT

+39 081 - 17770276; c.schettino@istitutotumori.na.it

Piera Gargiulo, MD

CONTACT

+39 081 - 17770276; piera.gargiulo@istitutotumori.na.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2023
• First Posted: September 13, 2023
• Study Start: October 30, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: November 13, 2023

Record last verified: 2023-09

Locations

IT (1)