Effect of Education for Relatives of Chemotherapy Patients on Family Health, Nutrition, and Psychological Well-Being
Phase: NA
Conditions: Caregiver Awareness, Family Health, Psychological Well-being, Chemotherapy
Sponsor: Yuzuncu Yil University

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Document Date: August 1, 2025 (Placeholder – replace with actual date of last 
protocol/SAP update or approval, e.g., ethics committee approval date) 
o Month: August 
o Day: 1 
o Year: 2025 
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Document Type: Study Protocol with Statistical Analysis Plan 
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Description: 
The Study Protocol with Statistical Analysis Plan (SAP) describes the randomized 
controlled trial conducted at Van University Hospital, Turkey, from February to August 
2025. The protocol includes: 
o Study Design: Parallel group, pre-test/post-test randomized controlled trial with 
171 caregivers (80 intervention, 91 control). 
o Objectives: To evaluate the effect of a structured educational intervention on 
caregivers’ psychological well-being, Mediterranean diet adherence, and family 
health. 
o Intervention: 30–45-minute education sessions delivered to 4–5 participants by 
a certified practitioner, covering self-efficacy, stress management, healthy 
lifestyle behaviors, and nutrition. 
o Data Collection: Measurements at baseline (t0), post-intervention (t1), and 6 
weeks post-intervention (t2) using validated scales. 
o Statistical Analysis Plan: Data analyzed using SPSS-25 with ki-kare tests, 
dependent t-tests, Pearson correlation, and Cohen’s d effect size. Normality 
assessed via skewness/kurtosis. Significance set at p<0.05. 
o Ethical Considerations: Approved by X University Health Sciences Research 
and Publication Ethics Committee, compliant with the Helsinki Declaration. 
The document is in English, PDF/A format, with a cover page including the 
official title ("Effect of Education Provided to Relatives of Chemotherapy 
Patients on Family Health, Nutrition, and Psychological Well-Being"), Ethical 
approval was obtained from the Scientific Research and Publication Ethics 

Committee of a university (approval number: 182158, approval date: 
10/02/2025). Institutional approval was then obtained from the hospital where 
the research was conducted. As the protection of individual rights was necessary 
in the research, the Helsinki Declaration of Human Rights was adhered to 
throughout the study. No participant names are included.