Childhood CancerNCT05457153
Technology-Based Well-Being Process Program (WEBEPROP) for Children and Adolescents in Palliative Care
A study testing Well-Being Process Program (WEBEPROP) in people with Childhood Cancer, run by Gazi University.
Trial summary
Objective: The research was planned to evaluate the effectiveness of the 8-week technology-based Well-Being Process program for children and adolescents in the palliative care period. Methods: This study was planned as a randomized controlled experimental study. Read more about this study
- Who is it for?
- Ages 10 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Cancer
- What is being tested?
- Well-Being Process Program (WEBEPROP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2022to 30 Sep 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 10 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Between the ages of 10-20,
- Child and adolescent with palliative care needs
- At least 3 months before diagnosis
- Child and adoescent have completed the induction phase of treatment,
- İntermediate-high-risk group defined under a treatment protocol,
- Child and aolescent can utilizecomputer, mobile phone and tablet
- Children and adolescents who agreed to participate in the survey and their parent.
Who cannot join
- Newly diagnosed with physical and mental disabilities,
- Child and adolescent with severe anxiety according to the anxiety score scale,
- Out of diagnosis in the last 6 months (loss of parents, natural disaster, etc.) are children and adolescents who experience high levels of stress and have an important psychiatric diagnosis that affects their mental health.
Trial locations and contacts
No sites are listed yet.
Ebru KILIÇARSLAN TORUNER,, PhD, RN contact
About this study
Official title: Intervention Protocol: Evaluation of the Effectiveness of the Technology-Based Well-Being Process Program (WEBEPROP) for Children and Adolescents in Palliative Care: A Randomized Trial
Objective: The research was planned to evaluate the effectiveness of the 8-week technology-based Well-Being Process program for children and adolescents in the palliative care period. Methods: This study was planned as a randomized controlled experimental study. The research will be carried out with children aged 12-20 years with a diagnosis of cancer, in the pediatric oncology and hematology clinics of two hospitals in Turkey. Data collection will consist of the children and adolescent's and parents' descriptive characteristic form Adolescent Spiritual Well-Being Scale, Beck Anxiety Scale, Pediatric Cancer Coping Scale and Technology-Based Spiritual Care Program Process Evaluation Forms. The program will be implemented for the intervention group. In the 8-week program; a) 4 web-based modules, b) 8 online individual interviews after each module (8 total interviews with each child) c) simultaneous mobile messages with the modules, and d) 24/7 counseling. Animation videos, breathing and progressive relaxation exercises, and imagination methods will be included in the modules. This research is based on the "Watson Model of Human Care".
Read the detailed description
Hypothesis:
H1: There is a significant difference between the spiritual well being score averages of children and adolescents who have been administered and have not been administered WEBEPROP.
H2: There is a significant difference between the anxiety scores of children and adolescents who have been administered and have not been administered WEBEPROP.
H3: There is a significant difference between the coping scores of children and adolescents who have been administered and have not been administered WEBEPROP.
- Conditions
- Childhood Cancer
- Being tested
- Well-Being Process Program (WEBEPROP)
- Keywords
- Palliative Care, Spiritualitiy, Spiritual Care, Cancer, Child
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Well-Being Process Program (WEBEPROP)Other
Technology-Based Well-Being Process Program (WEBEPROP)
| Study group | Role | What they receive |
|---|---|---|
| Technology-Based Well-Being Process Program | Experimental | WEBEPROP will be conducted for 8 weeks. The program for the intervention group is included the modüls. In the program, the modules of "Self-Knowledge, Inner Communication and Awareness of Perceptions, Emotion and Thought Management" will be completed in 8 weeks (each model two weeks) . The other module will not be accessible and cannot be switched before the prevous module is completed. Receives: Other: Well-Being Process Program (WEBEPROP) |
| Control Group | Active comparator | After the first follow-ups have been made to the control group, they will continue to receive standard care. After the monitoring of the initiative group within the scope of the program is completed, the website of the well-being process program will be made available to the control group. Children and adolescents will benefit from the modules by promoting the website. Receives: Other: Well-Being Process Program (WEBEPROP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Scale of Spiritual Well-Being in Adolescents (SSWA)
The scale developed by Törüner et al. assesses the spiritual well-being of adolescents aged 14-18 years. The scale, which is thought to help health professionals provide holistic care for adolescents, consists of a total of 34 items. Adolescents receive a minimum of 0 and a maximum of 136 points from the scale. As the score obtained from the scale increases, the spiritual well-being scores of adolescents increase. As the score obtained from the scale decreases, the spiritual well-being of the adolescents decreases. The Cronbach alpha value of the scale is 90.
Measured: The Scale of Spiritual Well-Beingscores will be checked at the beginning of the program "baseline"
Beck Anxiety Scale
The scale, which was developed by Beck et al. in 1988 to determine the level of anxiety (anxiety) of adult and adolescent individuals, consists of 21 items of the four-likert type. The Turkish validity and reliability study of the scale was conducted by Ulusoy et al. in 1993. Individuals are expected to be marked by their intensity of experiencing substances that are composed of symptoms and emotions commonly associated with anxiety. The sum of the scores was evaluated as 0-7: Minimal level of anxiety, 8-15: Mild level of anxiety, 16-25: Moderate level of anxiety, 26-63: Severe level of anxiety
Measured: Anxiety scores will be checked at the beginning of the program "baselıne
Pediatric Cancer Coping Scale (PCCS)
The scale developed by Wu et al. for children with cancer between the ages of 7 and 18 years. The Turkish validity and reliability of the scale was conducted by Sengul and Törüner (2019). There are a total of 33 items in the scale. There are three sub-dimensions of cognitive coping, problem-oriented coping and defensive coping. A minimum of 0 and a maximum of 99 points is obtained from the scale. High scores obtained from the scale indicate high levels of coping strategies. A low score means that coping skills are insufficient.In the original study of the scale, the Cronbach Alpha value was determined as 0.91
Measured: Coping scores will be checked at the beginning of the program "baseline"
Secondary outcomes (3)
The Scale of Spiritual Well-Being in Adolescents (SSWA)
The scale developed by Törüner et al. assesses the spiritual well-being of adolescents aged 14-18 years. The scale, which is thought to help health professionals provide holistic care for adolescents, consists of a total of 34 items. Adolescents receive a minimum of 0 and a maximum of 136 points from the scale. As the score obtained from the scale increases, the spiritual well-being scores of adolescents increase. As the score obtained from the scale decreases, the spiritual well-being of the adolescents decreases. The Cronbach alpha value of the scale is 90.
Measured: The Scale of Spiritual Well-Being scores will be checked completed"through study completion, an average of 1 week"
Beck Anxiety Scale
The scale, which was developed by Beck et al. in 1988 to determine the level of anxiety (anxiety) of adult and adolescent individuals, consists of 21 items of the four-likert type. The Turkish validity and reliability study of the scale was conducted by Ulusoy et al. in 1993. Individuals are expected to be marked by their intensity of experiencing substances that are composed of symptoms and emotions commonly associated with anxiety. The sum of the scores was evaluated as 0-7: Minimal level of anxiety, 8-15: Mild level of anxiety, 16-25: Moderate level of anxiety, 26-63: Severe level of anxiety
Measured: Anxiety scores will be checked completed"through study completion, an average of 1 week"
Pediatric Cancer Coping Scale (PCCS)
The scale developed by Wu et al. for children with cancer between the ages of 7 and 18 years. The Turkish validity and reliability of the scale was conducted by Sengul and Törüner (2019). There are a total of 33 items in the scale. There are three sub-dimensions of cognitive coping, problem-oriented coping and defensive coping. A minimum of 0 and a maximum of 99 points is obtained from the scale. High scores obtained from the scale indicate high levels of coping strategies. A low score means that coping skills are insufficient. In the original study of the scale, the Cronbach Alpha value was determined as 0.91
Measured: Coping scores will be checked completed "through study completion, an average of 1 week"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start1 Oct 2022 (estimated)
- Primary completion28 Feb 2023 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood CancerStudies of the same condition, open and under way.
- 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
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebru Kilicarslan Toruner, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05457153
- Sponsor's protocol ID
- 2021 - 846
- Status last verified
- Jul 2022
- First submitted
- 22 Jun 2022
- Last updated
- 13 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention Protocol: Evaluation of the Effectiveness of the Technology-Based Well-Being Process Program (WEBEPROP) for Children and Adolescents in Palliative Care: A Randomized Trial
- ClinicalTrials.gov ID
- NCT05457153
- Acronym / sponsor ID
- 2021 - 846
- Conditions
- Childhood Cancer
- Keywords
- Palliative Care, Spiritualitiy, Spiritual Care, Cancer, Child
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 28 Feb 2023 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 13 Jul 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.
Objective: The research was planned to evaluate the effectiveness of the 8-week technology-based Well-Being Process program for children and adolescents in the palliative care period. Methods: This study was planned as a randomized controlled experimental study. The research will be carried out with children aged 12-20 years with a diagnosis of cancer, in the pediatric oncology and hematology clinics of two hospitals in Turkey. Data collection will consist of the children and adolescent's and parents' descriptive characteristic form Adolescent Spiritual Well-Being Scale, Beck Anxiety Scale, Pediatric Cancer Coping Scale and Technology-Based Spiritual Care Program Process Evaluation Forms. The program will be implemented for the intervention group. In the 8-week program; a) 4 web-based modules, b) 8 online individual interviews after each module (8 total interviews with each child) c) simultaneous mobile messages with the modules, and d) 24/7 counseling. Animation videos, breathing and progressive relaxation exercises, and imagination methods will be included in the modules. This research is based on the "Watson Model of Human Care".
Detailed description
Hypothesis:
H1: There is a significant difference between the spiritual well being score averages of children and adolescents who have been administered and have not been administered WEBEPROP.
H2: There is a significant difference between the anxiety scores of children and adolescents who have been administered and have not been administered WEBEPROP.
H3: There is a significant difference between the coping scores of children and adolescents who have been administered and have not been administered WEBEPROP.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Technology-Based Well-Being Process Program | Experimental | Other: Well-Being Process Program (WEBEPROP)WEBEPROP will be conducted for 8 weeks. The program for the intervention group is included the modüls. In the program, the modules of "Self-Knowledge, Inner Communication and Awareness of Perceptions, Emotion and Thought Management" will be completed in 8 weeks (each model two weeks) . The other module will not be accessible and cannot be switched before the prevous module is completed. |
| Control Group | Active comparator | Other: Well-Being Process Program (WEBEPROP)After the first follow-ups have been made to the control group, they will continue to receive standard care. After the monitoring of the initiative group within the scope of the program is completed, the website of the well-being process program will be made available to the control group. Children and adolescents will benefit from the modules by promoting the website. |
Who may qualify
- Ages
- 10 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Between the ages of 10-20,
- Child and adolescent with palliative care needs
- At least 3 months before diagnosis
- Child and adoescent have completed the induction phase of treatment,
- İntermediate-high-risk group defined under a treatment protocol,
Key exclusion criteria (3 listed)
- Newly diagnosed with physical and mental disabilities,
- Child and adolescent with severe anxiety according to the anxiety score scale,
- Out of diagnosis in the last 6 months (loss of parents, natural disaster, etc.) are children and adolescents who experience high levels of stress and have an important psychiatric diagnosis that affects their mental health.
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 |
|---|---|---|
| Well-Being Process Program (WEBEPROP)Technology-Based Well-Being Process Program (WEBEPROP) | Other | Control Group, Technology-Based Well-Being Process Program |
Primary outcome
The Scale of Spiritual Well-Being in Adolescents (SSWA)
Time frame: The Scale of Spiritual Well-Beingscores will be checked at the beginning of the program "baseline"
The scale developed by Törüner et al. assesses the spiritual well-being of adolescents aged 14-18 years. The scale, which is thought to help health professionals provide holistic care for adolescents, consists of a total of 34 items. Adolescents receive a minimum of 0 and a maximum of 136 points from the scale. As the score obtained from the scale increases, the spiritual well-being scores of adolescents increase. As the score obtained from the scale decreases, the spiritual well-being of the adolescents decreases. The Cronbach alpha value of the scale is 90.
Beck Anxiety Scale
Time frame: Anxiety scores will be checked at the beginning of the program "baselıne
The scale, which was developed by Beck et al. in 1988 to determine the level of anxiety (anxiety) of adult and adolescent individuals, consists of 21 items of the four-likert type. The Turkish validity and reliability study of the scale was conducted by Ulusoy et al. in 1993. Individuals are expected to be marked by their intensity of experiencing substances that are composed of symptoms and emotions commonly associated with anxiety. The sum of the scores was evaluated as 0-7: Minimal level of anxiety, 8-15: Mild level of anxiety, 16-25: Moderate level of anxiety, 26-63: Severe level of anxiety
Pediatric Cancer Coping Scale (PCCS)
Time frame: Coping scores will be checked at the beginning of the program "baseline"
The scale developed by Wu et al. for children with cancer between the ages of 7 and 18 years. The Turkish validity and reliability of the scale was conducted by Sengul and Törüner (2019). There are a total of 33 items in the scale. There are three sub-dimensions of cognitive coping, problem-oriented coping and defensive coping. A minimum of 0 and a maximum of 99 points is obtained from the scale. High scores obtained from the scale indicate high levels of coping strategies. A low score means that coping skills are insufficient.In the original study of the scale, the Cronbach Alpha value was determined as 0.91
3 secondary outcomes
The Scale of Spiritual Well-Being in Adolescents (SSWA)
Time frame: The Scale of Spiritual Well-Being scores will be checked completed"through study completion, an average of 1 week"
Beck Anxiety Scale
Time frame: Anxiety scores will be checked completed"through study completion, an average of 1 week"
Pediatric Cancer Coping Scale (PCCS)
Time frame: Coping scores will be checked completed "through study completion, an average of 1 week"
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2022.
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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.
Ebru KILIÇARSLAN TORUNER,, PhD, RN contact
Questions about this trial
What is this clinical trial studying?
A study testing Well-Being Process Program (WEBEPROP) in people with Childhood Cancer, 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 7 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 13 Jul 2022. 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?
Contact Sümeyye YILDIZ, PhD Student (0534 682 37 94, sumeyye.yildiz1@gazi.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Scale of Spiritual Well-Being in Adolescents (SSWA) (time frame: The Scale of Spiritual Well-Beingscores will be checked at the beginning of the program "baseline"). The study lists 3 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 13 Jul 2022.