Active — Not RecruitingNot Applicable

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

Mexico236 participantsStarted 2025-12-10

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Psychosocial Assessment Tool

Timeframe: 3 months

Trial details

NCT IDNCT07321392

SponsorAquí Nadie Se Rinde I.A.P.

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-03

View on ClinicalTrials.gov More Pediatric Patients With Cancer trials