Effect of Education for Relatives of Chemotherapy Patients on Family Health, Nutrition, and Psychological Well-Being
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 171
- 试验地点
- 2
- 主要终点
- Psychological Well-Being Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Presence of cognitive or sensory impairments.
- •Failure to attend at least two education sessions (for intervention group).
- •Pregnancy.
- •Voluntary withdrawal from the study.
结局指标
主要结局
Psychological Well-Being Score
时间窗: 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.
Mediterranean Diet Adherence Score
时间窗: 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.
Family Health Score
时间窗: 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).
次要结局
- Correlation Between Psychological Well-Being and Family Health(Baseline (t0), immediately post-intervention (t1), and 6 weeks post-intervention (t2).)
- Correlation Between Psychological Well-Being and Mediterranean Diet Adherence(Baseline (t0), immediately post-intervention (t1), and 6 weeks post-intervention (t2).)
- Correlation Between Family Health and Mediterranean Diet Adherence(Baseline (t0), immediately post-intervention (t1), and 6 weeks post-intervention (t2).)
研究者
Muhammet Faruk Yigit
Assistant Prof. Dr.
Yuzuncu Yıl University