Clinical trial NCT05806983: Evaluation of the Efficiency of the Technology-Based Psychosocial Empowerment Program Program
Official title: Evaluation of the Efficiency of the Technology-Based Psychosocial Empowerment Program for Home Care of Children With Cancer and Their Parents
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer
Child, Only
Empowerment
Parents
Keywords: Cancer
Child
Parents
Home-care
Empowerment
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2023-04-10
Enrollment: 72
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: SUPPORTIVE_CARE

Brief 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 and Trait Anxiety Inventory for Children, the Pediatric Cancer Coping Scale, the General Self-Efficacy Scale for parents, the Problem-Solving Scale, and the Cope and Adaptatıon Process Scale. 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.

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

Primary outcomes:
measure: General Self-Efficacy Scale-Pediatric Cancer Version
timeFrame: Change from Baseline level 'Self Efficacy' to 2 months (change is being assessed)
measure: State-Trait Anxiety Inventory for Children
timeFrame: Change from Baseline level 'State-Trait Anxiety' to 2 months (change is being assessed)
measure: Pediatric Cancer Coping Scale
timeFrame: Change from Baseline level 'Pediatric Cancer Coping Scale' to 2 months (change is being assessed)
measure: General Self-Efficacy Scale
timeFrame: Change from Baseline level 'Self Efficacy' to 2 months (change is being assessed)
measure: Problem Solving Inventory
timeFrame: Change from Baseline level 'Problem Solving Inventory' to 2 months (change is being assessed)
measure: Coping and Adaptation Process Scale
timeFrame: Change from Baseline level 'Coping and Adaptation Process Scale' to 2 months (change is being assessed)
Secondary outcomes:
measure: SSPedi: Symptom Screening Scale in Pediatric Patients
timeFrame: While the intervention continues (1 months), the log records of the scale on the website will be evaluated.
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University
Study officials:
affiliation: Gazi University
name: Hazal Ozdemir Koyu, MD
role: PRINCIPAL_INVESTIGATOR
References: