An interventional study of AFRONTA Emotional Care in Caregiver Burden, Child and Cancer, sponsored by Universidad de Guanajuato. Completed at 1 site in Mexico. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Universidad de Guanajuato · Not applicable, Interventional, and Prevention
The objective of the protocol is to evaluate the acceptability and feasibility of "AFRONTA Emotional Care" to reduce caregiver burden in family caregivers of children with cancer at a children's cancer foundation in Pachuca, Hidalgo, Mexico. The main questions to be answered are:
The researchers will
The intervention "AFRONTA Emotional Care to Reduce Caregiver Overload" proposed to reduce the caregiver overload of a child with cancer through the strengthening of emotional coping strategies based on the management of anxiety, stress and depression, for which components that influence these same variables were considered from intervention studies and showing a relationship with the NIC taxonomy of nursing science. In this sense, the intervention was aimed at identifying emotional coping strategies, encouraging their use and providing new ways of coping which contribute to their well-being and stress management, which represents the main stimulus, according to the Middle Range Coping Theory. The scope of the intervention was based on providing tools for relaxation techniques, emotional support and, therefore, that caregivers have the fundamental bases for the management of anxiety, depression and stress.
On the other hand, each session was made up of a maximum of 10 people who received an intervention of 3 sessions of dialogue circles for the management of emotions supported by the technique of dialogue circles that aims to improve emotional coping and reduce caregiver overload from the creation of safe spaces (circles) that allow people to be protagonists of the situation, express with complete confidence problems, difficulties and feelings that are inherent to their role as caregivers, in addition to the expression of emotions and experiences that in a guided way they can share from an environment of confidentiality and mutual respect.
The caregivers' time is essential, therefore, the recommendation of the author like Tinoco who has had experiences in the application of dialogue circles mentions first hand that it is important not to exceed more than 3 circles because it is an unexplored population, so it can be counterproductive in the acceptability and viability of the study, since if more than 3 circles are proposed at the beginning, people may possibly reject the invitation for being too long. In addition to this, the intervention studies mentioned above also recommend a reduced number of sessions in this specific population.
Furthermore, agreements will be incorporated into the activities that allow for the appropriate use of voice, participation, and topics to be discussed. In the first circle, the facilitator will explain the methodology and dynamics of the circles, and then each participant will introduce themselves to the rest, one by one. The use of the article will be explained. This is a material object that indicates whose turn it is to speak at that moment and that the others should pay attention and remain silent. The object will be passed around the circle in the hands of the participants, giving each the opportunity to share their thoughts and feelings if they wish.
439 studies on the registry are indexed under Caregiver Burden; 154 are open to participants now.
This study's enrollment of 14 is below the median of 75 across 346 interventional studies indexed under Caregiver Burden.
Browse Caregiver Burden studies →Universidad de Guanajuato is the lead sponsor of 37 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
An intervention for caregivers consisting of five group sessions addressing the care involved in looking after a child with cancer, while emphasizing the importance of physical and emotional self-care in each session.
Other: AFRONTA Emotional Care
Group intervention in which caregivers express their feelings through the dialogue circle tool.
Also known as: AFRONTA, Emotional Care
Acceptability
It is assessed using the "Intervention Acceptability" questionnaire, which consists of 37 items organized into 6 sections: Section 1. Open-ended questions: positive aspects of the intervention and areas for improvement; Section 2. Intervention content; Section 3. Delivery method; Section 4. Benefits of the intervention; Section 5. Drawbacks of participating in the study; Part 6. Overall acceptability. The questions in Parts 2 through 6 use a Likert scale ranging from 1 to 5; higher scores indicate a higher level of acceptance of the intervention and its components. In addition, the study will be evaluated based on the enrollment rate (the number of people who agree to participate divided by the total number of people who met the inclusion criteria, multiplied by 100) and the dropout rate (the total number of people who drop out of the study divided by the total number who agreed to participate, multiplied by 100).
Time frame: 3 months
Feasibility
Feasibility is assessed descriptively based on five indicators: material resources, contextual characteristics, human resources, the interventionist's training, and implementation of the intervention (aspects of clarity, comprehensiveness, and logical sequence of the information provided to participants; the ease with which the intervention activities were carried out as directed; the time it took to deliver the various components of the intervention; relevance of the components; difficulties in implementing the recommendations)
Time frame: 3 months
Caregiver burden
Zarit Caregiver Burden Scale for Children with Chronic Illnesses: validated in Mexico by Montero, Jurado, Valencia, Méndez, and Mora in 2014, with a Cronbach's alpha of 0.84, criterion validity r = 0.46, and construct validity r = 0.36. It consists of 12 Likert-scale items (1=never, 2=almost never, 3=sometimes, 4=often, and 5=always). The cut-off scores are: 12 to 22 indicates no burden, 23 to 29 indicates mild burden, and 30 to 60 indicates excessive burden. It also consists of three dimensions or factors: the impact of care, interpersonal relationships, and self-efficacy expectations. The higher the score, the greater the burnout.
Time frame: 3 months
Plan to share: No — The data will not be shared with other researchers.
No publications or documents are linked to this record.
Ran from Jun 2025 to primary completion in Oct 2025, 4 months.
Of 253 non-industry interventional studies with no phase under Caregiver Burden, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 32. This study's 4 months is below that.
Counting every sponsor, half of 261 studies reached it within 16 months; a quarter within 7 and three quarters within 32.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Universidad de Guanajuato