Ignite Creation Date:
2025-12-24 @ 10:16 PM
Ignite Modification Date:
2026-01-02 @ 6:24 AM
Study NCT ID:
NCT05510635
Status:
COMPLETED
Last Update Posted:
2023-09-21
First Post:
2022-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effectiveness of Bibliotherapy on Emotional Distress, Coping Strategies and Resilience of Adolescents With Cancer
Sponsor:
National Yang Ming Chiao Tung University
Organization:
Study Overview
Official Title:
The Effectiveness of Bibliotherapy on Improving Emotional Distress and Coping Strategies and Enhancing Resilience of Adolescents With Cancer: A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Adolescents with cancer who were diagnosed within two years suffered severe emotional distress. Bibliotherapy therapy uses healing materials as a medium to enable individuals experiencing emotional distress to obtain emotional healing through story situations, thereby enhancing resilience. However, there is a lack of research on bibliotherapy in adolescents with cancer. Therefore, the investigators would like to evaluate the effectiveness of interactive bibliotherapy in improving emotional distress and coping strategies and enhancing the resilience of adolescents with cancer compared to reading bibliotherapy.
Detailed Description:
A multicenter randomized controlled trial will be conducted. Adolescents aged 10 to 19 years and diagnosed with cancer or relapse during the first two years will be included in the study. Seventy participants from three medical centers in northern Taiwan will be assigned to experimental or comparison groups through blocked randomization. The experimental group will receive the interactive bibliotherapy twice, and the comparison group will receive the reading bibliotherapy twice. The Positive and Negative Affect Schedule, Pediatric Cancer Coping Scale, and Haase Adolescent Resilience in Illness Scale will be used to measure participants' emotional distress, coping strategies and resilience at the time points of pre-intervention, after the intervention, and follow-up for a month after the intervention. An interview will be conducted over the intervention for a month. The generalized estimating equation will be used to analyze the two groups' emotional distress, coping strategies, and resilience. The content analysis will be performed to analyze the interview data. It is hoped that the results of this study can prove that bibliotherapy has the potential to improve emotional distress and coping strategies and enhance resilience in adolescents with cancer. This study is expected to provide health providers with novel evidence on the effectiveness of an intervention to take care of patients with cancer. Furthermore, this study provides an interdisciplinary intervention of nursing and other domain, and it may be extended to further research to improve patient care quality through cross-disciplinary coordination.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: