Caregiver AwarenessNCT07147868
Education for Chemotherapy Patients' Kin: Effects on Family Health
A study testing Structured Education Program for Caregivers of Chemotherapy Patients in people with Caregiver Awareness and Family Health, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caregiver Awareness, Family Health, Psychological Well-being
- What is being tested?
- Structured Education Program for Caregivers of Chemotherapy Patients
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 171 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Feb 2025to 18 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Presence of cognitive or sensory impairments.
- Failure to attend at least two education sessions (for intervention group).
- Pregnancy.
- Voluntary withdrawal from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Van Yuzuncu Yil University Hospital
Van, 65100
About this study
Official title: Effect of Education for Relatives of Chemotherapy Patients on Family Health, Nutrition, and Psychological Well-Being
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.
Read the 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.
- Being tested
- Structured Education Program for Caregivers of Chemotherapy Patients
- Keywords
- Chemotherapy, caregiver education, family health, psychological well-being, nutrition
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Education Program for Caregivers of Chemotherapy PatientsBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: Baseline (t0), immediately post-intervention (t1), and 6 weeks post-intervention (t2).
Secondary outcomes (3)
Correlation Between Psychological Well-Being and Family Health
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.
Measured: Baseline (t0), immediately post-intervention (t1), and 6 weeks post-intervention (t2).
Correlation Between Psychological Well-Being and Mediterranean Diet Adherence
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.
Measured: Baseline (t0), immediately post-intervention (t1), and 6 weeks post-intervention (t2).
Correlation Between Family Health and Mediterranean Diet Adherence
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.
Measured: Baseline (t0), immediately post-intervention (t1), and 6 weeks post-intervention (t2).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start10 Feb 2025
- Primary completion4 Mar 2025
- Study completion18 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Caregiver AwarenessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned to intervention or control groups and assessed at baseline, mid-intervention, and post-intervention
- Masking
- None (open label)
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammet Faruk Yigit, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07147868
- Sponsor's protocol ID
- 10.02.2025-182158
- Status last verified
- Aug 2025
- First submitted
- 15 Aug 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data (IPD) with other researchers. The study collected sensitive data, including sociodemographic information, psychological well-being scores, Mediterranean diet adherence scores, and family health scores, from caregivers of chemotherapy patients. Data sharing is not planned due to privacy and ethical considerations, as participant confidentiality is protected under the ethical approvals obtained from the X University Health Sciences Research and Publication Ethics Committee and in accordance with the Helsinki Declaration.
Publications
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.
PubMed 38572751
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Education for Relatives of Chemotherapy Patients on Family Health, Nutrition, and Psychological Well-Being
- ClinicalTrials.gov ID
- NCT07147868
- Acronym / sponsor ID
- 10.02.2025-182158
- Keywords
- Chemotherapy, caregiver education, family health, psychological well-being, nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- 4 Mar 2025 (actual)
- Study completion
- 18 Jul 2025 (actual)
- First posted
- 29 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomly assigned to intervention or control groups and assessed at baseline, mid-intervention, and post-intervention
| Arm | Type | Receives |
|---|---|---|
| Arm 1 (Experimental): Structured Caregiver Education Arm 2 (Control): No Structured Education | Experimental | Behavioral: Structured Education Program for Caregivers of Chemotherapy PatientsArm 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. |
| Control Group (No Intervention) | No intervention | –Relatives of chemotherapy patients received standard care without additional structured training. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- Presence of cognitive or sensory impairments.
- Failure to attend at least two education sessions (for intervention group).
- Pregnancy.
- Voluntary withdrawal from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured Education Program for Caregivers of Chemotherapy PatientsA 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). | Behavioural | Arm 1 (Experimental): Structured Caregiver Education Arm 2 (Control): No Structured Education |
Primary outcome
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.
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.
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).
3 secondary outcomes
Correlation Between Psychological Well-Being and Family Health
Time frame: Baseline (t0), immediately post-intervention (t1), and 6 weeks post-intervention (t2).
Correlation Between Psychological Well-Being and Mediterranean Diet Adherence
Time frame: Baseline (t0), immediately post-intervention (t1), and 6 weeks post-intervention (t2).
Correlation Between Family Health and Mediterranean Diet Adherence
Time frame: Baseline (t0), immediately post-intervention (t1), and 6 weeks post-intervention (t2).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Results publication: PubMed 38572751Bray 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.
- link addressLink provided by the sponsor.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data (IPD) with other researchers. The study collected sensitive data, including sociodemographic information, psychological well-being scores, Mediterranean diet adherence scores, and family health scores, from caregivers of chemotherapy patients. Data sharing is not planned due to privacy and ethical considerations, as participant confidentiality is protected under the ethical approvals obtained from the X University Health Sciences Research and Publication Ethics Committee and in accordance with the Helsinki Declaration.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Education Program for Caregivers of Chemotherapy Patients in people with Caregiver Awareness and Family Health, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychological Well-Being Score (time frame: Baseline (t0), immediately post-intervention (t1), and 6 weeks post-intervention (t2).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07147868, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.