CancerNCT05806983
Evaluation of the Efficiency of the Technology-Based Psychosocial Empowerment Program Program
A study testing Technology Based Psychosocial Program in people with Cancer and Child, Only, run by Gazi University at 1 site in Turkey (Türkiye).
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?
- Technology Based Psychosocial Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- 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,
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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, Parents
- Being tested
- Technology Based Psychosocial Program
- 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.
Technology Based Psychosocial ProgramOther
A technology-based model-based psychosocial empowerment program will be implemented for parents and children in the control group.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | -The experimental group that applied the technology-based psychosocial program Receives: Other: Technology Based Psychosocial Program |
| Control group | No intervention | Control group receiving standard 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
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.
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)
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.
Measured: 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
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 posted10 Apr 2023
- 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.
- 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
- Model description
- Parallel Assignment
- Masking
- Double blind
- Who is masked
- Participant, 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
- Investigators
- Hazal Ozdemir Koyu, MD, Principal investigator, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05806983
- Sponsor's protocol ID
- Technology Based Program
- Status last verified
- Mar 2023
- First submitted
- 29 Mar 2023
- Last updated
- 10 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
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficiency of the Technology-Based Psychosocial Empowerment Program for Home Care of Children With Cancer and Their Parents
- ClinicalTrials.gov ID
- NCT05806983
- Acronym / sponsor ID
- Technology Based Program
- Conditions
- Cancer, Child, Only, Empowerment, Parents
- 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
- 10 Apr 2023 (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 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Technology Based Psychosocial Program-The experimental group that applied the technology-based psychosocial program |
| Control group | No intervention | –Control 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 (3 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, 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,
Key exclusion criteria (1 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 |
|---|---|---|
| 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 |
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)
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.
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.
Coping and Adaptation Process Scale
Time frame: Change from Baseline level 'Coping and Adaptation Process Scale' to 2 months (change is being assessed)
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.
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 10 Apr 2023.
- Individual participant dataSharing planned: No. There are no plans to make individual participant data (IPD) available to other researchers
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
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.
Hazal Ozdemir Koyu, MD principal investigator
Gazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Technology Based Psychosocial Program in people with Cancer and Child, Only, run by Gazi University at 1 site in Turkey (Türkiye).
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 3 inclusion and 1 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 10 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Hazal Ozdemir Koyu, MD (905393239630, hazalozdemirkoyu@gazi.edu.tr), or a site near the patient. 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?
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 10 Apr 2023.