Examination of the Relationship Between Quality of Life and Caregiving Burden Among Caregivers of Pediatric Oncology Patients

NCT07308301 | Not Yet Recruiting

• 1 other identifier: 2024-KAEK-11
• Study Type: observational
• Target: 95
• Locations: 0 countries
• Sites: N/A

Brief 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. 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 Cancers; Caregiver Subjective Burden; Caregiver; Caregiver Anxiety; Caregiver Health Related QOL; Childhood Cancer; Primary Caregivers of Children Newly Diagnosed With Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  From the enrollment phase until the end of the 12-week data collection period.

Secondary Outcomes (1)

• Caregiver Burden Scale

  From the enrollment phase until the end of the 12-week data collection period.

Study Arms (1)

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.

Behavioral: Assessment of caregiver quality of life and burden

Interventions

Assessment of caregiver quality of life and burden BEHAVIORAL

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.

Primary caregivers eighteen and older of hospitalized pediatric cancer patients will be included.

Eligibility Criteria

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

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fatma Beyza Akdeniz: lead

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 4 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Pediatric Nurse

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: December 29, 2025
• Study Start: January 1, 2026
• Primary Completion: March 31, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: December 31, 2025

Record last verified: 2025-12