The Effectiveness of Bibliotherapy on Emotional Distress, Coping Strategies and Resilience of Adolescents With Cancer

Pediatric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05510635
• Other study ID #: T-24142-54260-19890
• Status: Completed
• Phase: N/A
• Start date: November 30, 2022
• Est. completion date: July 26, 2023

Study information

• Verified date: August 2022
• Source: National Yang Ming University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: July 26, 2023
• Est. primary completion date: July 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 19 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Adolescents who have psychiatric history.

Related Conditions & MeSH terms

• Emotional Distress
• Pediatric Cancer

Intervention

Other:
• interactive bibliotherapy
The researcher selected two picture books whose central issues are about the common emotional distress of adolescents with cancer, that is, negative emotion coping, and self-worth. The researcher will read the story to the participant and then use the interview guideline to discuss it with him or her one by one. The interview guideline for interactive bibliotherapy is listed according to the mechanism of bibliotherapy, including identification, catharsis, and insight, and additional questions leading a reader to think deeply.
• reading bibliotherapy
The researcher selected two picture books whose central issues are about the common emotional distress of adolescents with cancer, that is, negative emotion coping, and self-worth. The participant can take 20 to 25 minutes to read the story. No one can bother the participant during the intervention.

Locations

Country	Name	City	State
Taiwan	National Yang Ming Chiao Tung University	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Yang Ming University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	emotional distress	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.	Changes from Baseline to Post-Intervention and 1-month follow-up.
Primary	coping strategies	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.	Changes from Baseline to Post-Intervention and 1-month follow-up.
Primary	resilience	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.	Changes from Baseline to Post-Intervention and 1-month follow-up.