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

Adaptation of the Patient Reported Outcomes for Fighting Financial Toxicity of Cancer (PROFFIT) Instrument Into Turkish: A Validity and Reliability Study

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07088978
Enrollment
320
Registered
2025-07-28
Start date
2025-10-31
Completion date
2026-02-28
Last updated
2025-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

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.

Detailed description

The scale validity of the study will be evaluated through language and content validity, construct validity, criterion validity, and known-group validity methods; while the scale reliability will be assessed by calculating the Cronbach's alpha and McDonald's omega reliability coefficients.

Interventions

None listed

Sponsors

Giresun Training and Research Hospital
CollaboratorUNKNOWN
St. Mary's University, Twickenham
CollaboratorOTHER
Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale
CollaboratorNETWORK
Akdeniz University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* 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.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Validity Assessment-Language and Content ValidityThrough study completion, an average of 12 monthsLanguage 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.
Validity Assessment-Content Validity Index (CVI)Through study completion, an average of 12 monthsContent Validity Index (CVI) will be calculated based on expert ratings to determine the proportion of items deemed relevant.
Validity Assessment-Content Validity Ratio (CVR)Through study completion, an average of 12 monthsContent Validity Ratio (CVR) will be used to assess whether each item is essential for measuring the construct.
Validity Assessment-Construct ValidityThrough study completion, an average of 12 monthsConfirmatory 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.
Validity Assessment- Criterion ValidityThrough study completion, an average of 12 monthsThe 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.
Validity Assessment- Known-Group ValidityThrough study completion, an average of 12 monthsTo 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.
Reliability AssessmentThrough study completion, an average of 12 monthsInternal 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.

Contacts

Primary ContactZeynep Karakuş, PhD
zeynepkarakus@akdeniz.edu.tr+902423102965
Backup ContactZeynep Özer, PhD

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026