Education for Chemotherapy Patients' Kin: Effects on Family Health

NCT07147868 | Completed DMC

• 1 other identifier: 10.02.2025-182158
• Study Type: interventional
• Target: 171
• Locations: 1 country
• Sites: 1

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.

Conditions

Caregiver Awareness; Family Health; Psychological Well-being; Chemotherapy

Keywords

Chemotherapy; caregiver education; family health; psychological well-being; nutrition

Outcome Measures

Primary Outcomes (3)

• Psychological Well-Being Score

  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.

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

• Mediterranean Diet Adherence Score

  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.

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

• Family Health Score

  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).

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

Secondary Outcomes (3)

• 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).

Study Arms (2)

Arm 1 (Experimental): Structured Caregiver Education Arm 2 (Control): No Structured Education

EXPERIMENTAL

Arm Type: Experimental Relatives of chemotherapy patients received a structured training program covering self-efficacy, nutrition, and stress management. The training was delivered in group sessions supported by educational materials.

Behavioral: Structured Education Program for Caregivers of Chemotherapy Patients

Control Group (No Intervention)

NO INTERVENTION

Relatives of chemotherapy patients received standard care without additional structured training.

Interventions

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).

Arm 1 (Experimental): Structured Caregiver Education Arm 2 (Control): No Structured Education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Yuzuncu Yil University: lead

Study Sites (1)

Van Yuzuncu Yil University Hospital

Van, 65100, Turkey (Türkiye)

Location

Related Publications (1)

• Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, Jemal A. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. doi: 10.3322/caac.21834. Epub 2024 Apr 4.

  PMID: 38572751 RESULT

Related Links

• link address

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Prof. Dr.

Model Details: Participants were randomly assigned to intervention or control groups and assessed at baseline, mid-intervention, and post-intervention

Study Record Dates

• First Submitted: August 15, 2025
• First Posted: August 29, 2025
• Study Start: February 10, 2025
• Primary Completion: March 4, 2025
• Study Completion: July 18, 2025
• Last Updated: September 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)