Technology-Based Well-Being Process Program (WEBEPROP) for Children and Adolescents in Palliative Care

Childhood Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05457153
• Other study ID #: 2021 - 846
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: September 30, 2024

Study information

• Verified date: July 2022
• Source: Gazi University
• Contact: Sümeyye YILDIZ, PhD Student
• Phone: 0534 682 37 94
• Email: sumeyye.yildiz1[@]gazi.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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".

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: September 30, 2024
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 20 Years

Eligibility

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,

• Intermediate-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.

Related Conditions & MeSH terms

• Childhood Cancer

Intervention

Other:
• Well-Being Process Program (WEBEPROP)
Technology-Based Well-Being Process Program (WEBEPROP)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gazi University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	The Scale of Spiritual Well-Beingscores will be checked completed, "through study completion, one month"
Other	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	Anxiety scores will be checked completed, "through study completion, one month"
Other	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	Coping scores will be checked completed, "through study completion, one month
Primary	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.	The Scale of Spiritual Well-Beingscores will be checked at the beginning of the program "baseline"
Primary	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	Anxiety scores will be checked at the beginning of the program "baseline
Primary	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	Coping scores will be checked at the beginning of the program "baseline"
Secondary	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.	The Scale of Spiritual Well-Being scores will be checked completed"through study completion, an average of 1 week"
Secondary	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	Anxiety scores will be checked completed"through study completion, an average of 1 week"
Secondary	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	Coping scores will be checked completed "through study completion, an average of 1 week"