Clinical trial NCT05457153: Technology-Based Well-Being Process Program (WEBEPROP) for Children and Adolescents in Palliative Care
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Childhood Cancer
Keywords: Palliative Care
Spiritualitiy
Spiritual Care
Cancer
Child
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2022-07-13
Enrollment: 60
Sex: ALL
Minimum age (years): 10
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: The Scale of Spiritual Well-Being in Adolescents (SSWA)
timeFrame: The Scale of Spiritual Well-Beingscores will be checked at the beginning of the program "baseline"
measure: Beck Anxiety Scale
timeFrame: Anxiety scores will be checked at the beginning of the program "baselıne
measure: Pediatric Cancer Coping Scale (PCCS)
timeFrame: Coping scores will be checked at the beginning of the program "baseline"
Secondary outcomes:
measure: The Scale of Spiritual Well-Being in Adolescents (SSWA)
timeFrame: The Scale of Spiritual Well-Being scores will be checked completed"through study completion, an average of 1 week"
measure: Beck Anxiety Scale
timeFrame: Anxiety scores will be checked completed"through study completion, an average of 1 week"
measure: Pediatric Cancer Coping Scale (PCCS)
timeFrame: Coping scores will be checked completed "through study completion, an average of 1 week"
Other outcomes:
measure: The Scale of Spiritual Well-Being in Adolescents (SSWA)
timeFrame: The Scale of Spiritual Well-Beingscores will be checked completed, "through study completion, one month"
measure: Beck Anxiety Scale
timeFrame: Anxiety scores will be checked completed, "through study completion, one month"
measure: Pediatric Cancer Coping Scale (PCCS)
timeFrame: Coping scores will be checked completed, "through study completion, one month
Locations:
Study officials:
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