ClinicalTrials.gg
Status unknownNCT05566951Updated Apr 27, 2023

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

An interventional study of Psychosocial program and Standart care in Cancer, Child, Only and Empowerment, sponsored by Gazi University. Status unknown. Open to participants aged 8 Years to 18 Years. Per ClinicalTrials.gov, last updated 2023-04-27.

Sponsored by Gazi University · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Apr 2023), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
8 Years to 18 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cancer
  • Child, Only
  • Empowerment

Keywords

  • Cancer
  • Child
  • Parents
  • Home-care
  • Empowerment
03

In context

Neoplasms

9,610 studies on the registry are indexed under Neoplasms; 2,508 are open to participants now.

This study's planned enrollment of 72 is above the median of 50 across 7,429 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Gazi University is the lead sponsor of 548 studies on the registry; 104 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
72 participants (estimated)

Study arms

  • Experimental
    Experimental group

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

    Other: Psychosocial program

  • Other
    Control group

    Control group receiving standard care

    Other: Standart care

Interventions

  • OtherPsychosocial program

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

    Also known as: Technology-based psychosocial program

  • OtherStandart care

    Parents and children in the intervention group will be applied standard support approaches to be applied in the center where they receive treatment.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Change from Baseline level 'Self Efficacy' to 2 months (change is being assessed)

  2. State-Trait Anxiety Inventory for Children

    he 'State-Trait Anxiety Scale' for children between the ages of 8-18 was created to determine what the child feels at that moment, and the 'Stait-Trait Anxiety Scale' was created to determine what they usually feel. The higher the score, the higher the anxiety level.

    Time frame: Change from Baseline level 'State-Trait Anxiety' to 2 months (change is being assessed)

  3. 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.

    Time frame: Change from Baseline level 'Pediatric Cancer Coping Scale' to 2 months (change is being assessed)

  4. 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.

    Time frame: Change from Baseline level 'Self Efficacy' to 2 months (change is being assessed)

  5. 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.

    Time frame: Change from Baseline level 'Problem Solving Inventory' to 2 months (change is being assessed)

  6. Psychological Resilience Scale for Parents of Children with Cancer

    The Resilience Scale for Parents of Children was developed to examine the resilience status of parents of children aged 0-18 years with cancer diagnosis. The scale consists of 24 items and 4 sub-dimensions. As the score obtained from the scale increases, the level of psychological resilience of the parents increases.

    Time frame: Change from Baseline level 'Psychological Resilience Scale for Parents of Children with Cancer'' to 2 months (change is being assessed)

Secondary outcomes

  1. 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

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

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Ozdemir Koyu H, Kilicarslan E. Effectiveness of a Technology-Based Psychosocial Empowerment Program for Children With Cancer and Their Parents in Home-Based Care: A Randomized Controlled Trial. Psychooncology. 2026 Apr;35(4):e70463. doi: 10.1002/pon.70463. PubMed 41968280 ↗

Individual participant data

Plan to share: No — There are no plans to make individual participant data (IPD) available to other researchers.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05566951
Lead sponsor
Gazi University
Responsible party
Hazal Ozdemir Koyu (Research Assistant, Gazi University) — Principal investigator
First posted
Oct 5, 2022
Start date
Sep 2023 (estimated)
Primary completion
Sep 2024 (estimated)
Completion
Nov 2024 (estimated)
Last update
Apr 27, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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