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

NCT05806983 | Unknown DMC

• 1 other identifier: Technology Based Program
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Child, Only; Empowerment; Parents

Keywords

Cancer; Child; Parents; Home-care; Empowerment

Outcome Measures

Primary Outcomes (6)

• 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)

• 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)

• 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)

• 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)

Secondary Outcomes (1)

• SSPedi: Symptom Screening Scale in Pediatric Patients

  While the intervention continues (1 months), the log records of the scale on the website will be evaluated.

Study Arms (2)

Experimental group

EXPERIMENTAL

-The experimental group that applied the technology-based psychosocial program

Other: Technology Based Psychosocial Program

Control group

NO INTERVENTION

Control group receiving standard care

Interventions

Technology Based Psychosocial Program OTHER

A technology-based model-based psychosocial empowerment program will be implemented for parents and children in the control group.

Experimental group

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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,

You may not qualify if:

• 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

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neoplasms; Empowerment

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Officials

• Hazal Ozdemir Koyu, MD

  Gazi University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hazal Ozdemir Koyu, MD

CONTACT

905393239630; hazalozdemirkoyu@gazi.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: In the research, it was planned to blind the participant and outcome evaluation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: March 29, 2023
• First Posted: April 10, 2023
• Study Start: September 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: November 1, 2024
• Last Updated: April 10, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)