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Trial Title:
Technology-Based Psychosocial Empowerment Program for Home Care of Children With Cancer and Their Parents
NCT ID:
NCT05566951
Condition:
Cancer
Child, Only
Empowerment
Conditions: Keywords:
Cancer
Child
Parents
Home-care
Empowerment
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Single (Outcomes Assessor)
Masking description:
In the research, it was planned to blind the participant and outcome evaluation.
Intervention:
Intervention type:
Other
Intervention name:
Psychosocial program
Description:
A technology-based model-based psychosocial empowerment program will be implemented for
parents and children in the control group.
Arm group label:
Experimental group
Other name:
Technology-based psychosocial program
Intervention type:
Other
Intervention name:
Standart care
Description:
Parents and children in the intervention group will be applied standard support
approaches to be applied in the center where they receive treatment.
Arm group label:
Control group
Summary:
This research was planned to evaluate the effectiveness of the technology-based
psychosocial empowerment program for home care for children aged 8-18 years with cancer
and their parents as a parallel-group randomized controlled study design.The required
institutional permission and ethics committee approval was received.The study group of
the study consisted of 72 children and parents (intervention group [n=36], control group
[n=36]). Data were collected using the descriptive features form, the General
Self-Efficacy Scale-Pediatric Cancer Version, the State-Trait Anxiety Inventory for
Children, the Pediatric Cancer Coping Scale, the General Self-Efficacy Scale for parents,
the Problem Solving Inventory, and the Psychological Resilience Scale for Parents of
Children with Cancer. The data were stored in the SPSS 25 program.
Detailed description:
The incidence of childhood cancers has become an important health problem increasing all
over the world. Children and parents are affected in many dimensions physically,
psychologically, and socially during this experience. The needs of the child and parents
are not limited to the treatment period in the hospital. They also need to be supported
and strengthened during the home care process. The required institutional permission and
ethics committee approval was received. The study group of study consisted of 72 children
and parents (intervention group [n=36], control group [n=36]).The technology-based
program was applied to children and families for 4-6 weeks through modules on the
website. In addition, at the end of each module, online interviews or telephone
counseling will be applied.Children and parents in the control group will follow the
standard care procedures included in the treatment process. At the end of the study, it
was planned to apply website modules to the children and parents in the control group.
The research is based on the Psychological Empowerment Theory.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- For children's:
- Children between the ages of 8-18,
- Those receiving cancer treatment (leukemias and solid tumors) and completing the
first 2 months of the treatment process,
- Children with tablets, android phones and internet access
- Children whose parents and themselves agree to participate in the study,
- Children who can continue the study for 4-6 weeks,
- For primary care parents,
- Parents who can speak Turkish,
- Parents who can use computers and android mobile phones,
- Parents who agreed to participate in the study,
- Parents who can continue the study for 4-6 weeks,
Exclusion Criteria:
- Newly diagnosed children (in induction phase),
- Children who are in the terminal period or who are treated for relapse,
- Presence of another important disease (such as chronic disease, psychiatric
diagnosis) in the family that may prevent coping, other than the child followed up
with the diagnosis of cancer
Gender:
All
Minimum age:
8 Years
Maximum age:
18 Years
Healthy volunteers:
No
Start date:
September 2023
Completion date:
November 2024
Lead sponsor:
Agency:
Gazi University
Agency class:
Other
Source:
Gazi University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05566951
