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Childhood CancerNCT05982379

Motivation Program for Children With Cancer

A study testing Technology Based Motivation Program in people with Childhood Cancer, run by Zeynep Kisecik Şengül at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Purpose: To determine the effectiveness of the technology-based motivation program implemented with children with cancer diagnosis and their primary caregivers. Methods: This randomized controlled trial was completed with 31 children and 31 primary caregivers between the ages of 9 and18, who were being treated for… Read more about this study

Who is it for?
Ages 9 to 18 yearsHealthy volunteers can take part
Conditions the study is for
Childhood Cancer
What is being tested?
Technology Based Motivation Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
1 siteTurkey (Türkiye)
Study dates
2 Sep 2019to 28 Aug 2020
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 9 to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • For children:
  • Those having received cancer treatment (leukaemia, lymphomas and solid tumours),
  • Those aged 9-18 years,
  • Those who speak Turkish,
  • Those who have internet access on their smart phone or computer,
  • Self and primary caregiver having agreed to participate in the study, and
Show all 13Show fewer
  • Those who can continue the research for 9 weeks (Trying progressive relaxation exercises, breathing exercises and imagination at least twice a week).
  • For primary caregivers:
  • Those who speak Turkish,
  • Those who are literate,
  • Those who have internet access on their smart phones and computers,
  • Those who agree to participate in the research, and
  • Those who can continue the research for 9 weeks (Trying progressive relaxation exercises at least twice a week).

Who cannot join

  • Those who do not agree to participate in the research,
  • Those who have experienced significant life events in the last 6 months (migration, death, divorce etc.),
  • The presence of another important disease in the family that can increase stress and prevent coping, and
  • Those who do not have internet access.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Zeynep Kisecik Şengül

    Kirikkale

Other trials in Turkey (Türkiye)

About this study

Official title: Investigation Into the Impact of Technology-Based Motivation Program Applied to the Children Followed With Cancer Diagnosis and Their Families: A Randomized Controlled Study

Purpose: To determine the effectiveness of the technology-based motivation program implemented with children with cancer diagnosis and their primary caregivers.

Methods: This randomized controlled trial was completed with 31 children and 31 primary caregivers between the ages of 9 and18, who were being treated for cancer. A 10-week "Technology Based Motivation Program" was given to the intervention group. "State/ Trait Anxiety Inventory for Children", "Paediatric Quality of Life Inventory", "Paediatric Cancer Coping Scale", "State and Trait Anxiety Inventory," and "Process Evaluation Forms" were administered. Chi-square test, Fisher-Exact test, Independent Sample-t test, Man-Whitney U test, Wilcoxon test, Pearson and Spearman correlation coefficients were used for data analysis.

Read the detailed description

Design The study was conducted in two hospitals at Leukemia Polyclinic, Paediatric Haematology and Oncology Polyclinic, and Paediatric Haematology-Oncology Service from September 2019 to August 2020.

Setting and Samples In determining the research population, hospital registry information was used, and 119 children followed up with a diagnosis of cancer formed the research population. The sample of the research consisted of 44 children (leukaemia n = 33, solid tumour n = 11) and their primary caregivers meeting the inclusion criteria.

Randomization and blinding A stratified randomization method was used in the research. 44 children (leukaemia and solid tumour) who met the inclusion criteria were grouped according to gender (male and female) and age (9-13 years-14-18 years) and eight layers were obtained. Among the identified strata, intervention and control groups were randomized by an independent statistician using the website www.randomizer.org, 22 children were assigned to the intervention, and 22 to the control group. Five children from the intervention group and five children from the control group (unreachable (n=3), ex (n=1), refusal (n=4), Hematopoietic stem cell transplantation (HSCT) performed (n=1), intensive care unit admission (n=1)) could not be included in the research for various reasons and 34 children were included in the research. The purpose and content of the research were explained without informing the children and their primary caregivers that they were in the intervention or control group.

At the end of the research, the power analysis performed by using the mean scores of State Anxiety Inventory for Children with G * Power 3.0.10 program yielded a total of at least 28 samples that were found to be sufficient with 90% power and 5% margin of error (n1 = 14; n2 = 14).

Theoretical underpinnings The use of models is important in establishing the theoretical framework of research. In this research, the Transactional Stress and Coping Model of Lazarus and Folkman, which is the most widely used model in studies examining the coping and anxiety levels of children with cancer diagnosis, was used. The practices in the motivation program were created for the coping strategies of "seeking social support, self-control, positive evaluation and accepting responsibility" in the model.

Interventions The research consists of four stages. (1) Constructing training modules, (2) Creating a website, (3) Conducting preliminary intervention, and (4) Implementing the training modules with the children and primary caregivers in the intervention group.

Constructing training modules Four training modules for children and three training modules for primary caregivers were created by the researchers in line with the literature Content was added to the website after it was approved by 6 experts.

Creating the website The website was designed by a professional web design firm. The website can be accessed by computer, tablet and phone. There is an administrator and user panel on the website. Children and primary caregivers logged on the website with different passwords through the user panel and accessed the modules specially prepared for them.

Conducting preliminary intervention The preliminary intervention of the technology-based program was conducted with five children aged 9-18 years who were followed up with a diagnosis of leukaemia, and with their primary caregivers. As the child and primary caregivers found the program applicable as a result of the preliminary intervention, no change was made and it was included in the sample.

Using the training modules with children and primary caregivers in the intervention group The website and four training modules were used with the children in the intervention group. Nine coaching interviews with each child (once a week) were conducted over WhatsApp. The children were encouraged to do progressive relaxation and breathing exercises at least twice a week, and eight therapeutic stories (once a week) were sent to the child's phone in the form of animation.

Three training modules were used with the primary caregivers, and coaching interviews were conducted on WhatsApp twice during the program. Primary caregivers practiced progressive relaxation and breathing exercises at least twice a week. In addition, eight motivation messages were sent to the child and primary caregiver, and 24/7 consultancy was provided.

Control Group The routine practices of the children in the control group and their primary caregivers at the hospital continued. In addition, forms other than process evaluation were given to the child and their primary caregivers at the beginning and end of the program.

Data gathering After the children and primary caregivers who participated in the research were informed about the research in an empty room or in the room where they were treated during the polyclinic controls, data collection forms were given, the children and primary caregivers in the intervention group were subscribed to the website, and the exercises were explained in practice. It took approximately 60 minutes for the participants to fill out the forms and learn about the program. At the end of the research, the data collection forms (excluding the descriptive data form) were collected through WhatsApp messages.

Data collection tools Child and Parent Descriptive Characteristics Form, Spielberger State-Trait Anxiety Inventory, State/ Trait Anxiety Inventory for Children, Paediatric Cancer Coping Scale, Paediatric Quality of Life Inventory, and Process Evaluation Forms were used to collect the data.

Ethical considerations Permission for the research was obtained from the University Ethics Committee and Hospitals. Informed written consent was obtained from the children and their primary caregivers, who agreed to participate in the research, after written and verbal explanations were given to the patients to participate in the research. At the end of the study, all interventions were also performed with the control group.

Being tested
Technology Based Motivation Program
Keywords
Cancer, Child, Motivation, Program, Parent, Psychosocial, Technology
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Technology Based Motivation ProgramOther

    A 10-week "Technology Based Motivation Program" was given to the intervention group. The website and four training modules were used with the children in the intervention group. Nine coaching interviews with each child (once a week) were conducted over WhatsApp. The children were encouraged to do progressive relaxation and breathing exercises at least twice a week, and eight therapeutic stories (once a week) were sent to the child's phone in the form of animation.

    Three training modules were used with the primary caregivers, and coaching interviews were conducted on WhatsApp twice during the program. Primary caregivers practiced progressive relaxation and breathing exercises at least twice a week. In addition, eight motivation messages were sent to the child and primary caregiver, and 24/7 consultancy was provided.

Study groups in NCT05982379
Study groupRoleWhat they receive
InterventionExperimentalThis study was carried out with two groups. Technology Based Motivation Program were used for the intervention group.
Receives: Other: Technology Based Motivation Program
ControlNo interventionNo application was made to the control group, standard procedure was followed.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Anxiety levels of the children

    State/ Trait Anxiety Inventory for Children: 20 items for the State Anxiety, 20 items for the Trait Anxiety. The scores on the scale range from 20 to 60, and a high score indicates high anxiety.

    Measured: baseline (Initial interview) and through study completion (10th week)

  2. Children's quality of life scores

    Pediatric Quality of Life Inventory: The scale consists of 23 items and is scored from 0 to 100. The higher the score, the higher the quality of life

    Measured: baseline (Initial interview) and through study completion (10th week)

  3. Coping scores of the children

    Pediatric Cancer Coping Scale:The scale comprises 33 items related to cognitive coping, problem oriented coping, and defensive coping.The score obtained from the scale ranges from 0 to 99. Higher scores on the scale indicate a high level of coping strategies.

    Measured: baseline (Initial interview) and through study completion (10th week)

  4. Anxiety levels of the primary caregivers

    Spielberger State/ Trait Anxiety Inventory: 20 items of the 40-item scale are used to determine state anxiety and 20 items are used to determine trait anxiety.The scores on the scale range from 20 to 80, and the higher the score, the higher the level of anxiety.

    Measured: baseline (Initial interview) and through study completion (10th week)

Secondary outcomes (1)
  1. Application tracking forms

    Process evaluation forms:Six forms were prepared by the researchers. It was used to follow the practices and interviews of children and primary caregivers. 1. Website training follow-up form, 2. Mobile video interview follow-up form, 3. Counseling follow-up form, 4. Children's follow-up form for interventions, 5. Primary caregivers follow-up form for interventions, 6. Satisfaction and suggestion form

    Measured: Every week during the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2023
  2. Study start2 Sep 2019
  3. Primary completion1 Jun 2020
  4. Study completion28 Aug 2020

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
A randomized controlled trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05982379
Sponsor's protocol ID
ZSengul-experimental study
Status last verified
Aug 2023
First submitted
25 Jul 2023
Last updated
8 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The confidentiality of the data used in the study will be protected.

Publications

  • Kisecik Sengul Z, Kilicarslan E. Investigation into the impact of technology-based motivation program applied to children following cancer diagnosis and their families: a randomized controlled study. BMC Psychol. 2025 Aug 2;13(1):857. doi: 10.1186/s40359-025-03163-4.

    PubMed 40753403

Questions about this trial

What is this clinical trial studying?

A study testing Technology Based Motivation Program in people with Childhood Cancer, run by Zeynep Kisecik Şengül 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 13 inclusion and 4 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: finished, as of the sponsor's last update on 8 Aug 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Anxiety levels of the children (time frame: baseline (Initial interview) and through study completion (10th week)). The study lists 4 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 NCT05982379, 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 8 Aug 2023.

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