跳至主要内容
临床试验/CTRI/2025/05/087368
CTRI/2025/05/087368尚未招募不适用

Psycho-social Problems and the Mental Wellbeing of Childhood Cancer Survivors and Healthy children: A Cross-Sectional Comparative study from a Tertiary Cancer Centre.

Malabar Cancer Centre1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年2月6日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
120
试验地点
1
主要终点
1.To find the prevalence of psycho-social problems and mental wellbeing among childhood cancer survivors.

研究概览

简要总结

The research protocol examines the psycho-social problems and mental wellbeing of childhood cancer survivors compared to healthy children, using a cross-sectional comparative study at the Malabar Cancer Centre, Kerala.

Advances in medical science have improved childhood cancer survival rates, but survivors often face significant psycho-social challenges due to long-term physical, emotional, and cognitive effects of treatment. Existing studies indicate higher rates of depression, anxiety, and social difficulties among survivors compared to their healthy peers, though data from India remains sparse. This research seeks to bridge this gap by exploring these issues and identifying targeted interventions.

The study’s primary goal is to assess the prevalence of psycho-social problems and mental wellbeing among childhood cancer survivors. Secondary objectives include comparing these aspects between survivors and healthy children, analysing relationships between psycho-social problems and mental wellbeing, and exploring how survivor-related factors influence these outcomes.

The study uses a comparative cross-sectional design, enrolling 60 childhood cancer survivors aged 11-17 and an equal number of healthy children matched by age and demographics. Purposive sampling will be employed, with inclusion criteria ensuring that participants are free of psychiatric conditions and other health complications. The survivors must be six months post-treatment, and data will be collected using validated tools like the Strengths and Difficulties Questionnaire (SDQ) and the WHO-5 Wellbeing Index. Data collection is scheduled for December 2024 to June 2025.

The SDQ assesses emotional, behavioural, and social domains, while the WHO-5 evaluates mental wellbeing. Both tools are available in English and Malayalam, ensuring accessibility. Data will be statistically analysed using SPSS software. The study ensures ethical compliance, with approvals from institutional committees and informed consent from participants and guardians. Participant confidentiality is maintained, and any identified psychological needs will lead to referrals without disrupting the study.

This research could inform psycho-social support strategies for childhood cancer survivors in India, highlighting the importance of addressing emotional and behavioural health alongside physical recovery. Findings will be disseminated through academic publications and conferences.

The study underscores the critical need for comprehensive survivor care, emphasizing holistic approaches that promote long-term wellbeing.

研究设计

研究类型
Observational

入排标准

年龄范围
11.00 Year(s) 至 17.00 Year(s)(—)
性别
All

入选标准

  • Inclusion Criteria for Survivors: 1.Childhood cancer survivors currently in the age group of 11 years and 17 years.
  • 2.Survivors must have completed 6 months after their treatment from Malabar Cancer Centre.
  • 3.At least one parent is alive and is staying with the survivor.
  • 4.Survivors and legal guardian who can read, write, and understand Malayalam or English.
  • Inclusion Criteria for Healthy children: 1.Children in the age group of 11 years and 17 years.
  • 2.At least one parent is alive and is staying with the child.
  • 3.Children and legal guardian who can read, write and understand English or Malayalam.

排除标准

  • Exclusion Criteria: 1.Survivors and healthy children with history of any known psychiatric or psychological conditions or psycho-social interventions.
  • 2.Survivors and healthy children with a known history of sensory impairment or congenital physical disabilities or Intellectual Disability or cardiac or neurological diseases.
  • 3.Survivors who have been diagnosed with brain tumours.
  • 4.Survivors who have underwent Stem cell transplant treatment.
  • 6.Healthy children with known comorbidities or history of other health conditions.

结局指标

主要结局

1.To find the prevalence of psycho-social problems and mental wellbeing among childhood cancer survivors.

时间窗: NA

次要结局

  • To compare the psycho-social problems and mental wellbeing of the childhood cancer survivors and the healthy children.(Baseline)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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