CancerNCT05566951
Technology-Based Psychosocial Empowerment Program for Home Care of Children With Cancer and Their Parents
A study testing Psychosocial program and Standart care in people with Cancer and Child, Only, run by Gazi University.
Trial 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… Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Cancer, Child, Only, Empowerment
- What is being tested?
- Psychosocial program and Standart care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- Sep 2023to Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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,
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- 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,
Who cannot join
- 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
About this study
Official title: 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-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.
- Conditions
- Cancer, Child, Only, Empowerment
- Being tested
- Psychosocial program, Standart care
- Keywords
- Cancer, Child, Parents, Home-care, Empowerment
- Medical subject headings
- Neoplasms, Empowerment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychosocial programOther
Also called Technology-based psychosocial program
A technology-based model-based psychosocial empowerment program will be implemented for parents and children in the control group.
Standart careOther
Parents and children in the intervention group will be applied standard support approaches to be applied in the center where they receive treatment.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | -The experimental group that applied the technology-based psychosocial program Receives: Other: Psychosocial program |
| Control group | Other | Control group receiving standard care Receives: Other: Standart care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Baseline level 'Self Efficacy' to 2 months (change is being assessed)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from Baseline level 'Problem Solving Inventory' to 2 months (change is being assessed)
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.
Measured: 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
Measured: While the intervention continues (1 months), the log records of the scale on the website will be evaluated.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2022
- Study startSep 2023 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hazal Ozdemir Koyu, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05566951
- Sponsor's protocol ID
- Technology-Based Program
- Status last verified
- Apr 2023
- First submitted
- 23 Sep 2022
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans to make individual participant data (IPD) available to other researchers.
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency of the Technology-Based Psychosocial Empowerment Program for Home Care of Children With Cancer and Their Parents
- ClinicalTrials.gov ID
- NCT05566951
- Acronym / sponsor ID
- Technology-Based Program
- Conditions
- Cancer, Child, Only, Empowerment
- Keywords
- Cancer, Child, Parents, Home-care, Empowerment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- Sep 2023 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 5 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Psychosocial program-The experimental group that applied the technology-based psychosocial program |
| Control group | Other | Other: Standart careControl group receiving standard care |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- 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,
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychosocial programAlso: Technology-based psychosocial programA technology-based model-based psychosocial empowerment program will be implemented for parents and children in the control group. | Other | Experimental group |
| Standart careParents and children in the intervention group will be applied standard support approaches to be applied in the center where they receive treatment. | Other | Control group |
Primary outcome
General Self-Efficacy Scale-Pediatric Cancer Version
Time frame: Change from Baseline level 'Self Efficacy' to 2 months (change is being assessed)
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.
State-Trait Anxiety Inventory for Children
Time frame: Change from Baseline level 'State-Trait Anxiety' to 2 months (change is being assessed)
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.
Pediatric Cancer Coping Scale
Time frame: Change from Baseline level 'Pediatric Cancer Coping Scale' to 2 months (change is being assessed)
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.
General Self-Efficacy Scale
Time frame: Change from Baseline level 'Self Efficacy' to 2 months (change is being assessed)
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.
Problem Solving Inventory
Time frame: Change from Baseline level 'Problem Solving Inventory' to 2 months (change is being assessed)
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.
Psychological Resilience Scale for Parents of Children with Cancer
Time frame: Change from Baseline level 'Psychological Resilience Scale for Parents of Children with Cancer'' to 2 months (change is being assessed)
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.
1 secondary outcome
SSPedi: Symptom Screening Scale in Pediatric Patients
Time frame: While the intervention continues (1 months), the log records of the scale on the website will be evaluated.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
- Derived from this study: PubMed 41968280Ozdemir 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.
- Individual participant dataSharing planned: No. There are no plans to make individual participant data (IPD) available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Psychosocial program and Standart care in people with Cancer and Child, Only, run by Gazi University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General Self-Efficacy Scale-Pediatric Cancer Version (time frame: Change from Baseline level 'Self Efficacy' to 2 months (change is being assessed)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05566951, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2023.