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NCT Number: NCT07147868

Education for Chemotherapy Patients' Kin: Effects on Family Health

Aim: To evaluate the effects of structured education provided to the relatives of chemotherapy patients on family health, nutrition, and psychological well-being.

Methods: This randomized controlled study will be conducted with a parallel-group, pretest-posttest design at a university hospital in the northeastern region of Turkey. A total of 68 patient relatives are planned to participate (Intervention: 34, Control: 34). The training to be provided to the intervention group will cover topics such as self-efficacy, nutrition, and stress management. Data will be collected at three different time points (pretest, mid-test, posttest) using the Family Health Scale (FHS), the Mediterranean Diet Adherence Screener (MEDAS), and the Psychological Well-Being Scale (PWB). Statistical analyses will include chi-square tests, t-tests, and Pearson correlation coefficients.

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Key information

Conditions

Caregiver Awareness Behavior Chemotherapy Family Health Personal Satisfaction Psychological Well-Being

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Van Yuzuncu Yil University Hospital

Van, 65100, Turkey (Türkiye)

About this study

Aim: This study will evaluate the effects of structured education provided to the relatives of patients undergoing chemotherapy on family health, nutritional habits, and levels of psychological well-being.

Methods: The study is designed as a randomized controlled trial with a parallel-group, pretest-posttest design. It is planned to be conducted at a university hospital located in the northeastern region of Turkey, with a total of 68 patient relatives participating (Intervention Group: n = 34, Control Group: n = 34). The training materials will be developed to cover topics such as self-efficacy, nutrition, and stress management. Data will be collected using a participant information form, the Family Health Scale (FHS), the Mediterranean Diet Adherence Screener (MEDAS), and the Psychological Well-Being Scale (PWB) at three time points: t0 (pretest), t1 (mid-test), and t2 (posttest). Statistical analyses will include chi-square tests, paired sample t-tests for repeated measures, and Pearson correlation coefficients.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Caregiver (first-degree relative or emotional supporter) of a patient receiving chemotherapy.
  • Age 18 years or older.
  • Ability to read and understand Turkish.
  • Provides care or emotional support to the chemotherapy patient.
  • No chronic health conditions.
  • Not receiving psychiatric treatment.
  • No substance use.

Exclusion criteria

  • Presence of cognitive or sensory impairments.
  • Failure to attend at least two education sessions (for intervention group).
  • Pregnancy.
  • Voluntary withdrawal from the study.

Treatment and study plan

Structured Education Program for Caregivers of Chemotherapy Patients

Behavioral

A structured educational intervention designed for caregivers of cancer patients undergoing chemotherapy, delivered in 30-45 minute sessions to groups of 4-5 participants. The program includes modules on self-efficacy, stress management, healthy lifestyle behaviors, interpersonal relationships, and nutrition based on the Mediterranean diet. Content covers evidence-based strategies for improving family health, psychological well-being, and dietary adherence. Sessions are conducted by a certified practitioner with 480 hours of family counseling training in a university hospital's medical oncology unit seminar room. The intervention aims to reduce caregiver burden, enhance psychological well-being, improve adherence to the Mediterranean diet, and promote family health, as assessed by the Family Health Scale (ASÖ), Mediterranean Diet Adherence Scale (MEDAS), and Psychological Well-Being Scale (PİO) at baseline (t0), post-intervention (t1), and 6 weeks follow-up (t2).

Primary outcomes

  1. Psychological Well-Being Score

    Time frame: Baseline (t0), immediately post-intervention (t1), and 6 weeks post-intervention (t2).

    Description: Change in psychological well-being of caregivers, measured using the Psychological Well-Being Scale, an 8-item, 7-point Likert scale (scores range from 8 to 56, higher scores indicate better well-being). The scale assesses life satisfaction, stress coping, and positive emotions.

  2. Mediterranean Diet Adherence Score

    Time frame: Time Frame: Baseline (t0), immediately post-intervention (t1), and 6 weeks post-intervention (t2).

    Change in adherence to the Mediterranean diet among caregivers, measured using the Mediterranean Diet Adherence Scale, a 14-item scale (scores range from 0 to 14, higher scores indicate greater adherence). Scores ≥7 indicate acceptable adherence, and ≥9 indicate high adherence.

  3. Family Health Score

    Time frame: Baseline (t0), immediately post-intervention (t1), and 6 weeks post-intervention (t2).

    Change in family health levels among caregivers, measured using the Family Health Scale (FHS), short form (FHS-SF), a 10-item scale (scores range from 10 to 50, dichotomized to 0-10 for evaluation: 0-5 = poor, 6-8 = moderate, 9-10 = excellent family health).

Secondary outcomes

  1. Correlation Between Psychological Well-Being and Family Health

    Time frame: Baseline (t0), immediately post-intervention (t1), and 6 weeks post-intervention (t2).

    Assessment of the relationship between psychological well-being and family health among caregivers, measured using Pearson correlation analysis to evaluate the strength and direction of the association.

  2. Correlation Between Psychological Well-Being and Mediterranean Diet Adherence

    Time frame: Baseline (t0), immediately post-intervention (t1), and 6 weeks post-intervention (t2).

    Assessment of the relationship between psychological well-being and Mediterranean diet adherence among caregivers, measured using Pearson correlation analysis to evaluate the strength and direction of the association.

  3. Correlation Between Family Health and Mediterranean Diet Adherence

    Time frame: Baseline (t0), immediately post-intervention (t1), and 6 weeks post-intervention (t2).

    Assessment of the relationship between family health and Mediterranean diet adherence among caregivers, measured using Pearson correlation analysis to evaluate the strength and direction of the association.

Sponsors and collaborators

Lead sponsor

Yuzuncu Yil University

Other

Registry information

Official study title

Effect of Education for Relatives of Chemotherapy Patients on Family Health, Nutrition, and Psychological Well-Being

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 29, 2025
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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