Psychometric Validation of the Psychosocial Assessment Tool in Caregivers of Pediatric Cancer Patients.

NCT07321392 | Active Not Recruiting DMC

• 1 other identifier: HIM-2023-049
• Study Type: observational
• Target: 236
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pediatric Patients With Cancer; Informal Primary Caregivers

Keywords

Neoplasms; Child; Caregivers; Psychometrics; Psychological Tests

Outcome Measures

Primary Outcomes (1)

• Psychosocial Assessment Tool

  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.

  3 months

Interventions

Psychosocial Assessment Tool (PAT) DIAGNOSTIC_TEST

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. The total score, which ranges from 0 to 7, is assigned to the PPPHM 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 \[62\]. Then, an independent native Spanish speaker reviewed it and consulted with a certified translator.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants: For Spanish-English translation and back-translation According to the guidelines of the International Test Commission \[63\], the participation of an experienced native Mexican translator who is or has been immersed in the English-speaking culture will be required. On the other hand, for translation from English to Spanish, a native translator from an English-speaking country with experience who is immersed in Mexican culture will be required for translation from Spanish to English. For expert judging The participation of 10 psychologists who are experts in the following areas (psycho-oncology, health psychology and behavioural medicine with postgraduate qualifications for expert judging) will be required. For the piloting of the translated and validated version: 10 informal primary caregivers of pediatric cancer patients who come to the National Institute of Pediatrics will be necessary.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aquí Nadie Se Rinde I.A.P.: lead

Study Sites (1)

Aquí Nadie se Rinde I.A.P.

Mexico City, Mexico City, 04120, Mexico

Location

Related Publications (1)

• References: 1. Foreman KJ, Marquez N, Dolgert A, Fukutaki K, Fullman N, McGaughey M, et al. Forecasting life expectancy, years of life lost, and all-cause and cause-specific mortality for 250 causes of death: reference and alternative scenarios for 2016-40 for 195 countries and territories. Lancet. 2018; 392(10159):2052-90. https://pubmed.ncbi.nlm.nih.gov/30340847/ 2. Bray F, Jemal A, Grey N, Ferlay J, Forman D. Global cancer transitions according to the Human Development Index (2008-2030): a population-based study. Lancet Oncol. 2012; 13(8):790-801. https://pubmed.ncbi.nlm.nih.gov/22658655/ 3. CP W, E W, BW S. World Cancer Report: Cancer Research for Cancer Prevention [Internet]. [citado 19 de marzo de 2023]. Disponible en: https://publications.iarc.fr/Non-Series-Publications/World-Cancer-Reports/World-Cancer-Report-Cancer-Research-For-Cancer-Prevention-2020 4. Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, et al. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. mayo de 2021; 71(3):209-49. https://pubmed.ncbi.nlm.nih.gov/33538338/ 5. Home | Sustainable Development [Internet]. [cited 2023 March 19]. Available in: https://sdgs-un-org.pbidi.unam.mx:2443/ 6. NCD Countdown 2030 collaborators. NCD Countdown 2030: worldwide trends in non-communicable disease mortality and progress towards Sustainable Development Goal target 3.4. Lancet. 2018; 392(10152):1072-88. https://www.thelancet.com/pb-assets/Lancet/hubs/ncd/NCDCountdown2030_Summary_FINAL-1537452913640.PDF 7. NCD Countdown 2030 collaborators. NCD Countdown 2030: pathways to achieving Sustainable Development Goal target 3.4. Lancet. 2020; 396(10255):918-34. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(18)31992-5/fulltext 8. Kuderer NM, Choueiri TK, Shah DP, Shyr Y, Rubinstein SM, Rivera DR, et al. Clinical impact of COVID-19 on patients with cancer (CCC19): a cohort study. Lancet. 2020

  RESULT

MeSH Terms

Conditions

Neoplasms

Study Officials

• Alejandro Hernández-Posadas, M.A.

  Aquí Nadie Se Rinde I.A.P.

  PRINCIPAL INVESTIGATOR

• Laura Estefanía Montejo-Salas, M.A.

  Aquí Nadie Se Rinde I.A.P.

  STUDY CHAIR

• Norma Ayde González-Cisneros, B.A.

  Aquí Nadie Se Rinde I.A.P.

  STUDY CHAIR

• Fátima Sagrario Espinosa-Salgado, PhD.

  Instituto Nacional de Pediatría

  STUDY CHAIR

• Alberto Olaya-Vargas, PhD.

  Instituto Nacional de Pediatría

  STUDY CHAIR

• Rocío del Socorro Cárdenas-Cardos, PhD.

  Instituto Nacional de Pediatría

  STUDY CHAIR

• Liliana Velasco-Hidalgo, PhD.

  Instituto Nacional de Pediatría

  STUDY CHAIR

• José Felix Gaytán-Morales, PhD.

  Hospital Infantil de Mexico Federico Gomez

  STUDY CHAIR

• Shaila Rubí García-Zapotitla, Psic.

  Aquí Nadie Se Rinde I.A.P.

  STUDY CHAIR

• José Edén Martínez-Bojórquez, Psic.

  Aquí Nadie Se Rinde I.A.P.

  STUDY CHAIR

• Jonathan David Abrego-Rojas, B.A.

  Aquí Nadie Se Rinde I.A.P.

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: External researcher.

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: January 7, 2026
• Study Start: December 10, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)