Motivation Program for Children With Cancer

NCT05982379 | Completed

• 1 other identifier: ZSengul-experimental study
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Childhood Cancer

Keywords

Cancer; Child; Motivation; Program; Parent; Psychosocial; Technology

Outcome Measures

Primary Outcomes (4)

• 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.

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

• 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

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

• 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.

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

• 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.

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

Secondary Outcomes (1)

• Application tracking forms

  Every week during the intervention

Study Arms (2)

Intervention

EXPERIMENTAL

This study was carried out with two groups. Technology Based Motivation Program were used for the intervention group.

Other: Technology Based Motivation Program

Control

NO INTERVENTION

No application was made to the control group, standard procedure was followed.

Interventions

Technology Based Motivation Program OTHER

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.

Intervention

Eligibility Criteria

• Age: 9 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zeynep Kisecik Şengül: lead

Study Sites (1)

Zeynep Kisecik Şengül

Kırıkkale, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Zeynep Kisecik Şengül, RN, PhD

  Kırıkkale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Among the identified strata, intervention and control groups were randomized by an independent statistician using the website www.randomizer.org. The data of the study were entered by a person other than the researcher. Statistical analysis was performed by a person other than the researcher.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: A randomized controlled trial

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: August 8, 2023
• Study Start: September 2, 2019
• Primary Completion: June 1, 2020
• Study Completion: August 28, 2020
• Last Updated: August 8, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)