Adaptation of the PROFFIT Instrument Into Turkish: A Validity and Reliability Study

NCT07088978 | Not Yet Recruiting

• 1 other identifier: Akdeniz_University
• Study Type: observational
• Target: 320
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study is to evaluate the Turkish validity and reliability of the Patient Reported Outcomes for Fighting Financial Toxicity of Cancer (PROFFIT) developed in Italy.

Conditions

Cancer

Outcome Measures

Primary Outcomes (7)

• Validity Assessment-Language and Content Validity

  Language and Content Validity: To assess the relevance and appropriateness of the translated items, a panel of at least six experts in oncology, psychology, and instrument development will evaluate each item.

  Through study completion, an average of 12 months

• Validity Assessment-Content Validity Index (CVI)

  Content Validity Index (CVI) will be calculated based on expert ratings to determine the proportion of items deemed relevant.

  Through study completion, an average of 12 months

• Validity Assessment-Content Validity Ratio (CVR)

  Content Validity Ratio (CVR) will be used to assess whether each item is essential for measuring the construct.

  Through study completion, an average of 12 months

• Validity Assessment-Construct Validity

  Confirmatory Factor Analysis (CFA) will be performed to verify whether the factor structure of the Turkish version aligns with that of the original instrument. Model fit indices such as χ²/df, RMSEA, CFI, TLI, and SRMR will be used to evaluate the adequacy of the factor structure.

  Through study completion, an average of 12 months

• Validity Assessment- Criterion Validity

  The Turkish PROFFIT scores will be correlated with other established patient-reported outcome measures, specifically the COST (v2) and EORTC QLQ-C30 instruments, to assess convergent validity. Pearson or Spearman correlation coefficients will be used to determine the strength of associations between PROFFIT and these validated measures.

  Through study completion, an average of 12 months

• Validity Assessment- Known-Group Validity

  To assess whether the instrument can differentiate between groups with known differences in financial toxicity, mean scores of the total and subscales will be compared across predefined demographic and clinical groups. Independent samples t-tests and ANOVA will be performed to compare group differences.

  Through study completion, an average of 12 months

• Reliability Assessment

  Internal Consistency: The reliability of the Turkish PROFFIT instrument will be evaluated using: Cronbach's alpha (α) to assess the overall internal consistency of the scale. McDonald's omega (ω) as an alternative measure that provides a more robust estimation of reliability in multidimensional scales.

  Through study completion, an average of 12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Turkish-speaking and literate volunteers over the age of 18 diagnosed with solid cancer or hematologic malignancy who have received cancer treatment (chemotherapy, targeted therapy, immunotherapy, hormonal therapy, radiotherapy, or a combination of these treatments) within the last three months.

You may qualify if:

• Individuals diagnosed with solid cancer or hematologic malignancy, either histologically or cytologically, and aware of their diagnosis,
• Those who have received cancer treatment (chemotherapy, targeted therapy, immunotherapy, hormonal therapy, radiotherapy, or a combination of these treatments) within the last three months,
• Individuals over the age of 18,
• Those without a diagnosed psychiatric illness (such as depression, panic attacks, schizophrenia, etc.),
• Individuals without auditory or cognitive impairments,
• Turkish-speaking and literate volunteers.

You may not qualify if:

• Individuals who fill out the data collection forms incompletely or wish to withdraw from the study.

Sponsors & Collaborators

• Akdeniz University: lead
• Giresun Training and Research Hospital: collaborator
• St. Mary's University, Twickenham: collaborator
• Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale: collaborator

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Zeynep Karakuş, PhD

CONTACT

+902423102965; zeynepkarakus@akdeniz.edu.tr

Zeynep Özer, PhD

CONTACT

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant, PhD

Study Record Dates

• First Submitted: June 2, 2025
• First Posted: July 28, 2025
• Study Start: October 1, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: October 2, 2025

Record last verified: 2025-09