Caregiver BurdenNCT07874958
"AFRONTA Emotional Care" Intervention for Family Caregivers of Children With Cancer.
A study testing AFRONTA Emotional Care in people with Caregiver Burden and Child, run by Universidad de Guanajuato at 1 site in Mexico.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caregiver Burden, Child, Cancer
- What is being tested?
- AFRONTA Emotional Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteMexico
- Study dates
- 1 Jun 2025to 30 Oct 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- parent of a child with cancer
- primary caregiver
- experiencing a mild or excessive burden
Who cannot join
- psychological therapy, medical or psychiatric treatment for emotional problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "AFRONTA Emotional Care" Intervention for Family Caregivers of Children With Cancer: A Pilot Study of Acceptability and Feasibility
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:
- What is the acceptability and feasibility of "AFRONTA Emotional Care"?
- Does the AFRONTA Emotional Care intervention reduce caregiver burden in family caregivers of children with cancer?
Read more
The researchers will
- Implement a series of therapeutic sessions based on a dialogue circle where
- They will guide specific objectives related to caregiver burden characteristics
- They will administer a questionnaire before and after the sessions to evaluate the results The participants will
- Sign informed consent
- Attend the dialogue circle sessions
- Develop exercise-based activities that promote active listening, respect, and empathy.
- Wait your turn to speak and speak up (converse)
- Promote the collective development of ideas and the resolution of care-related conflicts.
Read the detailed description
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.
- Conditions
- Caregiver Burden, Child, Cancer
- Being tested
- AFRONTA Emotional Care
- Keywords
- Caregiver burden, cancer child
- Medical subject headings
- Caregiver Burden, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AFRONTA Emotional CareOther
Also called AFRONTA, Emotional Care
Group intervention in which caregivers express their feelings through the dialogue circle tool.
| Study group | Role | What they receive |
|---|---|---|
| Caregivers of children with cancer | Experimental | 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. Receives: Other: AFRONTA Emotional Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
Measured: 3 months
Secondary outcomes (1)
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start1 Jun 2025
- Primary completion20 Oct 2025
- Study completion30 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caregiver BurdenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- According to Sidani and Braden, it is essential to evaluate a newly created intervention in a first phase of intervention evaluation that focuses on assessing acceptability and feasibility. Likewise, in order to approximate the results of the dependent variable, it is also suggested to evaluate it as preliminary results. In this sense, the research design by manipulation of the variables will be pre-experimental with a group performing pretest and posttest measurements, which contributes to focusing on obtaining more information about the acceptability and feasibility of the intervention due to its flexibility. In addition, it is suggested as a first approach to the research problem in reality and should be used as tests for larger studies with greater control. Due to the capture of information, it will be prolific because information will be obtained before the maneuver and the result.
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Guanajuato
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Autónoma del Estado de Hidalgo
- Responsible party
- Principal investigator, José Manuel Herrera Paredes, Universidad de Guanajuato
- Investigators
- Aldo Pelcastre Neri, Doctor in Nursing Science, Principal investigator, Universidad Autónoma del Estado de Hidalgo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07874958
- Sponsor's protocol ID
- CIDCSI-REG-2025-018
- Other IDs
- DCSI-CCS
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will not be shared with other researchers.