Caregiver Awareness, Chemotherapy, Family Health, Psychological Well-being
Conditions
Keywords
Chemotherapy, caregiver education, family health, psychological well-being, nutrition
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALStructured Education Program for Caregivers of Chemotherapy Patients
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).
Sponsors
Yuzuncu Yil University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Participants were randomly assigned to intervention or control groups and assessed at baseline, mid-intervention, and post-intervention
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Psychological Well-Being Score | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Correlation Between Psychological Well-Being and Family Health | 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. |
| Correlation Between Psychological Well-Being and Mediterranean Diet Adherence | 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. |
| Correlation Between Family Health and Mediterranean Diet Adherence | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed