Evaluation of the Efficiency of the Technology-Based Psychosocial Empowerment Program Program

Evaluation of the Efficiency of the Technology-Based Psychosocial Empowerment Program for Home Care of Children With Cancer and Their Parents

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cancer; Parents; Child, Only; Empowerment
• Intervention / Treatment: Other: Technology Based Psychosocial 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.

• Study Type: Interventional
• Enrollment (Anticipated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hazal Ozdemir Koyu, MD; Phone Number: 905393239630; Email: hazalozdemirkoyu@gazi.edu.tr

Study Locations

• Turkey
  • Ankara, Turkey
    • Gazi University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; -The experimental group that applied the technology-based psychosocial program	Other: Technology Based Psychosocial Program; A technology-based model-based psychosocial empowerment program will be implemented for parents and children in the control group.
No Intervention: Control group; Control group receiving standard care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Coping and Adaptation Process Scale	The scale is a scale that enables individuals to define coping and adaptation strategies in critical and difficult situations. The scale consists of 47 items and five sub-dimensions. Scale items are scored between 1 and 4. As the score obtained from the scale and subscales increases, it is interpreted as the use of effective coping methods increases.	Change from Baseline level 'Coping and Adaptation Process Scale' to 2 months (change is being assessed)
General Self-Efficacy Scale-Pediatric Cancer Version	It is a one-dimensional, 10-item scale used to evaluate self-efficacy in children aged 8-18 years with cancer.As the score obtained from the scale increases, the level of self-efficacy also increases.	Change from Baseline level 'Self Efficacy' to 2 months (change is being assessed)
Pediatric Cancer Coping Scale	It was developed to evaluate coping in children aged 7-18 years with cancer diagnosis. The scale consists of 3 sub-dimensions as cognitive coping, problem-focused coping and defensive coping. The higher the score, the higher the coping strategies.	Change from Baseline level 'Pediatric Cancer Coping Scale' to 2 months (change is being assessed)
General Self-Efficacy Scale	It is a one-dimensional scale developed to evaluate the general self-efficacy level of adults.As the score obtained from the scale increases, the level of self-efficacy also increases.	Change from Baseline level 'Self Efficacy' to 2 months (change is being assessed)
Problem Solving Inventory	It is a scale that measures the problem solving skills of individuals according to the perception of the individual.The inventory consists of three sub-dimensions: Safe in Problem Solving, Approach Avoidance Style and Personal Control.Low scores from the inventory indicate the ability to produce effective solutions to problems, while high scores indicate the inability to find effective solutions to problems.	Change from Baseline level 'Problem Solving Inventory' to 2 months (change is being assessed)
State-Trait Anxiety Inventory for Children	The 'State Anxiety Scale' for children between the ages of 8-18 was created to determine what the child feels at that moment, and the 'Trait Anxiety Scale' was created to determine what they usually feel. The higher the score, the higher the anxiety level.	Change from Baseline level 'State-Trait Anxiety' to 2 months (change is being assessed)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SSPedi: Symptom Screening Scale in Pediatric Patients	The screening tool includes 15 symptoms that evaluate the symptoms children have experienced in the last two days. Each symptom is evaluated with a 5-point Likert-type scoring system, and the score range varies between 0-60. Higher scores indicate that the number of symptoms and the discomfort they cause increase.	While the intervention continues (1 months), the log records of the scale on the website will be evaluated.

Collaborators and Investigators

• Sponsor: Gazi University
• Investigators: Principal Investigator: Hazal Ozdemir Koyu, MD, Gazi University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2023
• Primary Completion (Anticipated): September 1, 2024
• Study Completion (Anticipated): November 1, 2024

Study Registration Dates

• First Submitted: March 29, 2023
• First Submitted That Met QC Criteria: March 29, 2023
• First Posted (Actual): April 10, 2023

Study Record Updates

• Last Update Posted (Actual): April 10, 2023
• Last Update Submitted That Met QC Criteria: March 29, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Child; Cancer; Parents; Empowerment; Home-care
• Other Study ID Numbers: Technology Based Program

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There are no plans to make individual participant data (IPD) available to other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No