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

July 10, 2022 updated by: Ebru Kilicarslan Toruner, Gazi University

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".

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 20 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Technology-Based Well-Being Process Program
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.
Other: Well-Being Process Program (WEBEPROP)
Technology-Based Well-Being Process Program (WEBEPROP)
Active Comparator: Control Group
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.
Other: Well-Being Process Program (WEBEPROP)
Technology-Based Well-Being Process Program (WEBEPROP)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
The Scale of Spiritual Well-Beingscores will be checked at the beginning of the program "baseline"
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
Anxiety scores will be checked at the beginning of the program "baselıne
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
Coping scores will be checked at the beginning of the program "baseline"

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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"
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"
Beck Anxiety Scale
Time Frame: Anxiety scores will be checked completed"through study completion, an average of 1 week"
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"
Pediatric Cancer Coping Scale (PCCS)
Time Frame: Coping scores will be checked completed "through study completion, an average of 1 week"
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"

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Scale of Spiritual Well-Being in Adolescents (SSWA)
Time Frame: The Scale of Spiritual Well-Beingscores will be checked completed, "through study completion, one month"
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"
Beck Anxiety Scale
Time Frame: Anxiety scores will be checked completed, "through study completion, one month"
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"
Pediatric Cancer Coping Scale (PCCS)
Time Frame: Coping scores will be checked completed, "through study completion, one month
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gazi University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2022

Primary Completion (Anticipated)

February 28, 2023

Study Completion (Anticipated)

September 30, 2024

Study Registration Dates

First Submitted

June 22, 2022

First Submitted That Met QC Criteria

July 10, 2022

First Posted (Actual)

July 13, 2022

Study Record Updates

Last Update Posted (Actual)

July 13, 2022

Last Update Submitted That Met QC Criteria

July 10, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2021 - 846

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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