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临床试验/NCT05510635
NCT05510635已完成不适用

The Effectiveness of Bibliotherapy on Improving Emotional Distress and Coping Strategies and Enhancing Resilience of Adolescents With Cancer: A Randomized Controlled Trial

National Yang Ming Chiao Tung University2 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2022年11月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
27
试验地点
2
主要终点
emotional distress

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
10 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Adolescents aged 10 to 19 years.
  • Adolescents were diagnosed with leukemia or osteosarcoma.
  • Adolescents were diagnosed with cancer or relapsed during the first two years.
  • Adolescents who have received cancer treatment.
  • Adolescents who can read picture books and communicate with Chinese.

排除标准

  • Adolescents who have psychiatric history.

结局指标

主要结局

emotional distress

时间窗: Changes from Baseline to Post-Intervention and 1-month follow-up.

The Positive and Negative Affect Schedule will be used to measure participants' emotional distress. The Positive and Negative Affect Schedule is composed of a 20-item questionnaire separated into two subscales, positive and negative affect. Each item is assessed on a 5-point Likert scale, varying from 1 to 5, obtaining total points ranging from 10 to 50 on each subscale. Higher scores suggest higher levels of positive or negative affect.

coping strategies

时间窗: Changes from Baseline to Post-Intervention and 1-month follow-up.

The Pediatric Cancer Coping Scale (PCCS) will be used to measure participants' coping strategies. The PCCS is composed of a 33-item questionnaire separated into three subscales, including cognitive coping (14 items), problem-oriented coping (9 items), and defensive coping (10 items). The PCCS is also separated into two parts. The first part of the scale is used to measure the usage frequency of each item, and the second part evaluates the efficacy of each strategy. Each item is assessed on a 4-point Likert scale, varying from 0 to 3. The score for each subscale is calculated by adding all corresponding item scores. Higher scores represent the higher usage frequency of strategies or the more effective coping strategies.

resilience

时间窗: Changes from Baseline to Post-Intervention and 1-month follow-up.

The Haase Adolescent Resilience in Illness Scale will be used to measure participants' resilience. The Haase Adolescent Resilience in Illness Scale is composed of a 13-item questionnaire. Each item is assessed on a 6-point Likert scale, varying from 1 to 6, obtaining total points ranging from 13 to 78, with higher scores representing higher resilience.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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