Childhood CancerNCT07308301
Examination of the Relationship Between Quality of Life and Caregiving Burden Among Caregivers of Pediatric Oncology Patients
An observational study of Childhood Cancer and Childhood Cancers, run by Fatma Beyza Akdeniz.
Trial summary
Primary Aim The primary aim of this study is to determine the quality of life and caregiving burden levels of caregivers of pediatric oncology patients and to examine the relationship between these two variables. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Childhood Cancer, Childhood Cancers, Caregiver Subjective Burden
- What is being tested?
- Assessment of caregiver quality of life and burden
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 95 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 30 Jun 2026
- How long will I take part?
- 4 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: The study includes individuals who provide care for pediatric oncology patients. Primary caregivers aged 18 years and older who provide care for children diagnosed with cancer and who are hospitalized in the Pediatric Hematology-Oncology Unit of Başakşehir Çam and Sakura City Hospital will be included in the study. The study will examine caregivers' sociodemographic characteristics, quality of life, and levels of caregiving burden.
Who may be able to join
- Being a family member who provides care for a child aged 0-18 years diagnosed with cancer
- The child being in the active treatment phase (chemotherapy, radiotherapy, post-surgical follow-up, etc.)
- Being able to read and write in Turkish and having sufficient literacy to complete the research questionnaire
- Willingness to participate in the study
Who cannot join
- Not being the primary caregiver of the child (serving only as a short-term companion)
- Being unable to complete the questionnaire due to a psychiatric diagnosis or communication difficulties
- The child having a disability
About this study
Official title: EXAMİNATİON OF THE RELATİONSHİP BETWEEN QUALİTY OF LİFE AND CAREGİVİNG BURDEN AMONG CAREGİVERS OF PEDİATRİC OCOLOGY PATİENTS
Primary Aim
The primary aim of this study is to determine the quality of life and caregiving burden levels of caregivers of pediatric oncology patients and to examine the relationship between these two variables.
Read more
Secondary Aims
To evaluate the differences between caregivers' sociodemographic characteristics (age, gender, education level, marital status, income level, etc.) and their quality of life.
To examine the differences between caregivers' sociodemographic characteristics and their caregiving burden levels.
To determine whether caregivers' quality of life and caregiving burden differ according to the diagnosis and treatment characteristics of pediatric oncology patients (duration of diagnosis, type of treatment, frequency of hospitalization, etc.).
Significance of the Study
Childhood cancer is a process that deeply affects not only the patient but also the family, particularly the caregivers. Family members who provide care for children often face intense physical, psychological, social, and economic burdens. These challenges reduce caregivers' quality of life and increase their caregiving burden.
Identifying the relationship between the quality of life and caregiving burden among caregivers of pediatric oncology patients is highly important in planning support services for families during the care process and in strengthening family-centered care practices by healthcare professionals.
The findings of this study will contribute to the development of family-centered approaches in nursing care, the design of psychosocial support programs, and a better understanding of caregivers' needs.
- Conditions
- Childhood Cancer, Childhood Cancers, Caregiver Subjective Burden, Primary Caregivers of Children Newly Diagnosed With Cancer, Caregiver, Caregiver Anxiety
- Being tested
- Assessment of caregiver quality of life and burden
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of caregiver quality of life and burdenBehavioural
This intervention consists of assessing the quality of life and caregiving burden of primary caregivers of children diagnosed with cancer using standardized questionnaires and scales. It does not involve any medical procedures, treatments, or experimental applications. The intervention includes only the administration of data collection tools to caregivers and is therefore distinct from treatment-based interventions used in other clinical studies.
| Study group | Role | What they receive |
|---|---|---|
| Primary caregivers eighteen and older of hospitalized pediatric cancer patients will be included. | The study includes individuals who provide care for pediatric oncology patients. The research will involve primary caregivers aged 18 years or older who provide care for a child diagnosed with cancer and who are currently hospitalized in the Pediatric Hematology and Oncology Unit of Başakşehir Çam and Sakura City Hospital. The study will examine caregivers' sociodemographic characteristics, quality of life, and caregiving burden levels. Receives: Behavioral: Assessment of caregiver quality of life and burden |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caregiver Quality of Life Index-Cancer (CQOLC)
The scale consists of 25 items and four subscales: burden (10 items: 9, 11, 14, 15, 18, 19, 20, 21, 25, 31), disruptiveness (6 items: 1, 2, 3, 5, 13, 29), positive adaptation (6 items: 17, 24, 26, 30, 32, 33), and financial distress (3 items: 6, 7, 8). The scale is rated on a Likert-type scale ranging from 0 (almost never), 1 (not much), 2 (somewhat), 3 (quite a bit), to 4 (very much).
Subscale scores of the CQOLC are calculated by summing the items within each subscale. The total CQOLC score is obtained by summing all 25 items. The total CQOLC score ranges from 0 to 100, with higher scores indicating lower quality of life. The overall internal consistency coefficient of the scale is .88, while the Cronbach's alpha values for the subscales of burden, disruptiveness, positive adaptation, and financial distress are reported as .83, .79, .73, and .77, respectively.
Measured: From the enrollment phase until the end of the 12-week data collection period.
Secondary outcomes (1)
Caregiver Burden Scale
The scale consists of 36 items rated on a 5-point Likert scale and includes four subscales. The emotional burden subscale comprises 12 items, the sociocultural and economic burden subscale comprises 11 items, the mental burden subscale comprises 7 items, and the physical burden subscale comprises 6 items. Participants completing the scale indicate their level of agreement with statements related to the caregiving burden experienced during the process of caring for their child using the following response options: "1 = Never, 2 = Rarely, 3 = Sometimes, 4 = Often, 5 = Always." The minimum possible total score is 36 (36 items × 1 point), and the maximum possible total score is 180 (36 items × 5 points). The caregiver burden level is determined by summing the responses to all items. Accordingly, mean score ranges are interpreted as follows: mean scores of 1.00-2.00 indicate "no or low burden," 2.00-3.00 indicate "mild to moderate burden," 3.00-4.00-5.00 indicate "
Measured: From the enrollment phase until the end of the 12-week data collection period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start1 Jan 2026 (estimated)
- Primary completion31 Mar 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood CancerStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 95 participants (estimated)
- Target duration
- 4 Months
Sponsor and investigators
- Lead sponsor
- Fatma Beyza Akdeniz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fatma Beyza Akdeniz, Fenerbahce University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07308301
- Sponsor's protocol ID
- 2024-KAEK-11
- Status last verified
- Dec 2025
- First submitted
- 15 Dec 2025
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EXAMİNATİON OF THE RELATİONSHİP BETWEEN QUALİTY OF LİFE AND CAREGİVİNG BURDEN AMONG CAREGİVERS OF PEDİATRİC OCOLOGY PATİENTS
- ClinicalTrials.gov ID
- NCT07308301
- Acronym / sponsor ID
- 2024-KAEK-11
- Conditions
- Childhood Cancer, Childhood Cancers, Caregiver Subjective Burden, Primary Caregivers of Children Newly Diagnosed With Cancer, Caregiver, Caregiver Anxiety
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 95 participants (estimated)
- Lead sponsor
- Fatma Beyza AkdenizUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 29 Dec 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.
Primary Aim
The primary aim of this study is to determine the quality of life and caregiving burden levels of caregivers of pediatric oncology patients and to examine the relationship between these two variables.
Secondary Aims
To evaluate the differences between caregivers' sociodemographic characteristics (age, gender, education level, marital status, income level, etc.) and their quality of life.
To examine the differences between caregivers' sociodemographic characteristics and their caregiving burden levels.
To determine whether caregivers' quality of life and caregiving burden differ according to the diagnosis and treatment characteristics of pediatric oncology patients (duration of diagnosis, type of treatment, frequency of hospitalization, etc.).
Significance of the Study
Childhood cancer is a process that deeply affects not only the patient but also the family, particularly the caregivers. Family members who provide care for children often face intense physical, psychological, social, and economic burdens. These challenges reduce caregivers' quality of life and increase their caregiving burden.
Identifying the relationship between the quality of life and caregiving burden among caregivers of pediatric oncology patients is highly important in planning support services for families during the care process and in strengthening family-centered care practices by healthcare professionals.
The findings of this study will contribute to the development of family-centered approaches in nursing care, the design of psychosocial support programs, and a better understanding of caregivers' needs.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 4 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary caregivers eighteen and older of hospitalized pediatric cancer patients will be included. | – | Behavioral: Assessment of caregiver quality of life and burdenThe study includes individuals who provide care for pediatric oncology patients. The research will involve primary caregivers aged 18 years or older who provide care for a child diagnosed with cancer and who are currently hospitalized in the Pediatric Hematology and Oncology Unit of Başakşehir Çam and Sakura City Hospital. The study will examine caregivers' sociodemographic characteristics, quality of life, and caregiving burden levels. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study includes individuals who provide care for pediatric oncology patients. Primary caregivers aged 18 years and older who provide care for children diagnosed with cancer and who are hospitalized in the Pediatric Hematology-Oncology Unit of Başakşehir Çam and Sakura City Hospital will be included in the study. The study will examine caregivers' sociodemographic characteristics, quality of life, and levels of caregiving burden.
Key inclusion criteria (4 listed)
- Being a family member who provides care for a child aged 0-18 years diagnosed with cancer
- The child being in the active treatment phase (chemotherapy, radiotherapy, post-surgical follow-up, etc.)
- Being able to read and write in Turkish and having sufficient literacy to complete the research questionnaire
- Willingness to participate in the study
Key exclusion criteria (3 listed)
- Not being the primary caregiver of the child (serving only as a short-term companion)
- Being unable to complete the questionnaire due to a psychiatric diagnosis or communication difficulties
- The child having a disability
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 |
|---|---|---|
| Assessment of caregiver quality of life and burdenThis intervention consists of assessing the quality of life and caregiving burden of primary caregivers of children diagnosed with cancer using standardized questionnaires and scales. It does not involve any medical procedures, treatments, or experimental applications. The intervention includes only the administration of data collection tools to caregivers and is therefore distinct from treatment-based interventions used in other clinical studies. | Behavioural | Primary caregivers eighteen and older of hospitalized pediatric cancer patients will be included. |
Primary outcome
Caregiver Quality of Life Index-Cancer (CQOLC)
Time frame: From the enrollment phase until the end of the 12-week data collection period.
The scale consists of 25 items and four subscales: burden (10 items: 9, 11, 14, 15, 18, 19, 20, 21, 25, 31), disruptiveness (6 items: 1, 2, 3, 5, 13, 29), positive adaptation (6 items: 17, 24, 26, 30, 32, 33), and financial distress (3 items: 6, 7, 8). The scale is rated on a Likert-type scale ranging from 0 (almost never), 1 (not much), 2 (somewhat), 3 (quite a bit), to 4 (very much). Subscale scores of the CQOLC are calculated by summing the items within each subscale. The total CQOLC score is obtained by summing all 25 items. The total CQOLC score ranges from 0 to 100, with higher scores indicating lower quality of life. The overall internal consistency coefficient of the scale is .88, while the Cronbach's alpha values for the subscales of burden, disruptiveness, positive adaptation, and financial distress are reported as .83, .79, .73, and .77, respectively.
1 secondary outcome
Caregiver Burden Scale
Time frame: From the enrollment phase until the end of the 12-week data collection period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Childhood Cancer and Childhood Cancers, run by Fatma Beyza Akdeniz.
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 4 inclusion and 3 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: opening soon, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Caregiver Quality of Life Index-Cancer (CQOLC) (time frame: From the enrollment phase until the end of the 12-week data collection period.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Dec 2025.