CancerNCT07088978
Adaptation of the PROFFIT Instrument Into Turkish: A Validity and Reliability Study
An observational study of Cancer, run by Akdeniz University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- How many people
- 320 participants
- Where
- No sites listed yet
- Study dates
- Oct 2025to Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Individuals who fill out the data collection forms incompletely or wish to withdraw from the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Zeynep Özer, PhD contact
About this study
Official title: Adaptation of the Patient Reported Outcomes for Fighting Financial Toxicity of Cancer (PROFFIT) Instrument Into Turkish: A Validity and Reliability Study
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.
Read the 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.
- Conditions
- Cancer
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through study completion, an average of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study startOct 2025 (estimated)
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Akdeniz UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Collaborators
- Giresun Training and Research Hospital, St. Mary's University, Twickenham, Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale
- Responsible party
- Principal investigator, Zeynep KARAKUŞ, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07088978
- Sponsor's protocol ID
- Akdeniz_University
- Status last verified
- Sep 2025
- First submitted
- 2 Jun 2025
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation of the Patient Reported Outcomes for Fighting Financial Toxicity of Cancer (PROFFIT) Instrument Into Turkish: A Validity and Reliability Study
- ClinicalTrials.gov ID
- NCT07088978
- Acronym / sponsor ID
- Akdeniz_University
- Conditions
- Cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Collaborators
- Giresun Training and Research Hospital, St. Mary's University, Twickenham, Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale
- Study start
- Oct 2025 (estimated)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 28 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (1 listed)
- Individuals who fill out the data collection forms incompletely or wish to withdraw from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Validity Assessment-Language and Content Validity
Time frame: Through study completion, an average of 12 months
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.
Validity Assessment-Content Validity Index (CVI)
Time frame: Through study completion, an average of 12 months
Content Validity Index (CVI) will be calculated based on expert ratings to determine the proportion of items deemed relevant.
Validity Assessment-Content Validity Ratio (CVR)
Time frame: Through study completion, an average of 12 months
Content Validity Ratio (CVR) will be used to assess whether each item is essential for measuring the construct.
Validity Assessment-Construct Validity
Time frame: Through study completion, an average of 12 months
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.
Validity Assessment- Criterion Validity
Time frame: Through study completion, an average of 12 months
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.
Validity Assessment- Known-Group Validity
Time frame: Through study completion, an average of 12 months
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.
Reliability Assessment
Time frame: Through study completion, an average of 12 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zeynep Özer, PhD contact
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Akdeniz University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zeynep Karakuş, PhD (+902423102965, zeynepkarakus@akdeniz.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validity Assessment-Language and Content Validity (time frame: Through study completion, an average of 12 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.