- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05510635
The Effectiveness of Bibliotherapy on Emotional Distress, Coping Strategies and Resilience of Adolescents With Cancer
September 19, 2023 updated by: National Yang Ming University
The Effectiveness of Bibliotherapy on Improving Emotional Distress and Coping Strategies and Enhancing Resilience of Adolescents With Cancer: A Randomized Controlled Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
27
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 Locations
-
-
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Taipei, Taiwan, 11221
- National Yang Ming Chiao Tung University
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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 19 years (Child, Adult)
Accepts Healthy Volunteers
No
Description
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.
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: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: interactive bibliotherapy
All adolescents enrolled in the experimental group will receive two times of interactive bibliotherapy with an interval of 7 to 14 days.
The researcher will read the story to the participant and then discuss it with him/her.
|
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.
|
|
Active Comparator: reading bibliotherapy
All adolescents enrolled in the comparison group will receive two times of reading bibliotherapy with an interval of 7 to 14 days.
The participant will read the story alone.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
emotional distress
Time Frame: Changes from Baseline to Post-Intervention and 1-month follow-up.
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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.
|
|
coping strategies
Time Frame: 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.
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Changes from Baseline to Post-Intervention and 1-month follow-up.
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resilience
Time Frame: Changes from Baseline to Post-Intervention and 1-month follow-up.
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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.
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Changes from Baseline to Post-Intervention and 1-month follow-up.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Actual)
November 30, 2022
Primary Completion (Actual)
July 26, 2023
Study Completion (Actual)
July 26, 2023
Study Registration Dates
First Submitted
August 14, 2022
First Submitted That Met QC Criteria
August 19, 2022
First Posted (Actual)
August 22, 2022
Study Record Updates
Last Update Posted (Actual)
September 21, 2023
Last Update Submitted That Met QC Criteria
September 19, 2023
Last Verified
August 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- T-24142-54260-19890
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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