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临床试验/NCT07321392
NCT07321392进行中(未招募)不适用

PSYCHOMETRIC VALIDATION OF THE PSYCHOSOCIAL ASSESSMENT TOOL IN CAREGIVERS OF PEDIATRIC CANCER PATIENTS.

Aquí Nadie Se Rinde I.A.P.1 个研究点 分布在 1 个国家目标入组 236 人开始时间: 2025年12月10日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
236
试验地点
1
主要终点
Psychosocial Assessment Tool

研究概览

简要总结

The reported mental health, economic and structural problems of pediatric cancer patients end up negatively affecting family functioning and the course of the disease; therefore, in the Mexican context it is necessary to have a valid, reliable and culturally relevant tool to identify psychosocial risks in children and adolescents with cancer. in order to develop strategies to address psychosocial needs. Objective: To determine the psychometric validation of the Mexican version of the Psychosocial Assessment Tool (PAT) for informal primary caregivers of pediatric cancer patients. Method: A study will be carried out with a prospective multicenter instrumental design of correlational scope and a non-probabilistic sampling will be used at the convenience of informal primary caregivers of pediatric cancer patients. The indices of relevance, writing and adequate language will be evaluated, in order to obtain content validity of each of the 68 items, using the Aiken V, reliability will be evaluated by calculating the Kuder-Richardson 20 coefficient to determine internal consistency and structural or construct validity will be evaluated by means of an exploratory factor analysis. Results: According to the guidelines for adaptation and validation of psychological instruments, the inventory will be translated into the original language (English - Spanish), the inventory will be backtranslated into the original language (Spanish - English), the evidence of content validity will be obtained by expert judges, and the evidence of construct validity and reliability indices of the inventory will be piloted and obtained with the white sample.

Keywords: Pediatric patients, cancer, psychosocial risk, informal primary caregivers, pediatric oncology.

详细描述

In the Mexican context, it is necessary to have a valid, reliable and culturally relevant tool to identify psychosocial risks in children and adolescents with cancer, because, due to social, economic, cultural and psychological factors, these patients and their families are at risk, therefore, the validation of the psychosocial risk is not the same as theThe psychometric analysis of the Psychosocial Assessment Tool would allow an adequate diagnosis so that the multidisciplinary team can use interventions aimed at the specific needs of the patient and their relatives in multiple contexts where they work, regardless of the type of neoplasm or the phase of treatment in which they are.

Hypothesis

Statistical hypothesis:

Validation based on internal structure H1: r ≥ 0.7 H0: r < 0.7 Validation content-based H1: V ≥ 0.8 H0: V < 0.8

Methodological hypotheses:

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Informal primary caregivers of pediatric cancer patients, who verbally state that they have assumed responsibility for care from diagnosis to survival.
  • Informal primary caregivers of pediatric cancer patients over 18 years of age.
  • Informal primary caregivers of pediatric cancer patients who can read and write.
  • Informal primary caregivers of pediatric cancer patients who are receiving chemotherapy and/or radiation therapy.
  • Informal primary caregivers of pediatric cancer patients who agree to participate in the study.

排除标准

  • Informal primary secondary caregivers of pediatric cancer patients.
  • Informal primary caregivers of pediatric cancer patients who have participated in the piloting of the study.
  • Informal primary caregivers of pediatric cancer patients who are receiving palliative care treatment.
  • Informal primary caregivers of pediatric cancer patients who are in remission.

结局指标

主要结局

Psychosocial Assessment Tool

时间窗: 3 months

The PAT is a brief report for informal primary caregivers that assesses family psychosocial risk based on a families' ecological social model. This model assesses psychosocial risks throughout the child's social environment and generates seven subscale scores, such as Family Structure/Resources, Social Support, Children's Problems, Sibling Problems, Family Problems, Stress Reactions, and Family Beliefs \[61\]. The total score, which ranges from 0 to 7, is assigned to the PPPHM (Kazak, 2006) with three risk levels: universal (\<1.00), specific (1.00 and 2.00) and clinical (\>2.00). To translate the PAT into Spanish, methods that met or exceeded the guidelines of Holmbeck and Devine were used. First, the PAT was independently translated and back-translated by two native Spanish-speaking psychologists. Then, an independent native Spanish speaker reviewed it and consulted with a certified translator.

次要结局

未报告次要终点

研究者

发起方
Aquí Nadie Se Rinde I.A.P.
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alejandro Hernández Posadas

External researcher.

Aquí Nadie Se Rinde I.A.P.

研究点 (1)

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