Emotional DistressNCT05510635
The Effectiveness of Bibliotherapy on Emotional Distress, Coping Strategies and Resilience of Adolescents With Cancer
A study testing interactive bibliotherapy and reading bibliotherapy in people with Emotional Distress and Pediatric Cancer, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 10 to 19 years
- Conditions the study is for
- Emotional Distress, Pediatric Cancer
- What is being tested?
- interactive bibliotherapy and reading bibliotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteTaiwan
- Study dates
- 30 Nov 2022to 26 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Adolescents who have psychiatric history.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Emotional Distress, Pediatric Cancer
- Being tested
- interactive bibliotherapy, reading bibliotherapy
- Keywords
- adolescent, bibliotherapy, emotional distress, coping, resilience
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interactive bibliotherapyOther
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 bibliotherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| interactive bibliotherapy | Experimental | 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. Receives: Other: interactive bibliotherapy |
| reading bibliotherapy | Active comparator | 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. Receives: Other: reading bibliotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Changes from Baseline to Post-Intervention and 1-month follow-up.
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.
Measured: Changes from Baseline to Post-Intervention and 1-month follow-up.
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.
Measured: Changes from Baseline to Post-Intervention and 1-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start30 Nov 2022
- Primary completion26 Jul 2023
- Study completion26 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Emotional DistressStudies of the same condition, open and under way.
- More trials run by National Yang Ming Chiao Tung UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05510635
- Sponsor's protocol ID
- T-24142-54260-19890
- Status last verified
- Aug 2022
- First submitted
- 14 Aug 2022
- Last updated
- 21 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wu TJ, Sheih CS, Jou ST, Lee CY, Yu TY, Liu CY, Chen CW. Effects of bibliotherapy on emotional distress, coping strategies, and resilience in adolescents with cancer: A pilot randomized controlled trial. Eur J Oncol Nurs. 2025 Jun;76:102900. doi: 10.1016/j.ejon.2025.102900. Epub 2025 May 10.
PubMed 40381380
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Bibliotherapy on Improving Emotional Distress and Coping Strategies and Enhancing Resilience of Adolescents With Cancer: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05510635
- Acronym / sponsor ID
- T-24142-54260-19890
- Conditions
- Emotional Distress, Pediatric Cancer
- Keywords
- adolescent, bibliotherapy, emotional distress, coping, resilience
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 30 Nov 2022 (actual)
- Primary completion
- 26 Jul 2023 (actual)
- Study completion
- 26 Jul 2023 (actual)
- First posted
- 22 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| interactive bibliotherapy | Experimental | Other: interactive bibliotherapyAll 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. |
| reading bibliotherapy | Active comparator | Other: reading bibliotherapyAll 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. |
Who may qualify
- Ages
- 10 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- Adolescents who have psychiatric history.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| interactive bibliotherapyThe 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. | Other | interactive bibliotherapy |
| reading bibliotherapyThe 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. | Other | reading bibliotherapy |
Primary outcome
emotional distress
Time frame: 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
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.
resilience
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Derived from this study: PubMed 40381380Wu TJ, Sheih CS, Jou ST, Lee CY, Yu TY, Liu CY, Chen CW. Effects of bibliotherapy on emotional distress, coping strategies, and resilience in adolescents with cancer: A pilot randomized controlled trial. Eur J Oncol Nurs. 2025 Jun;76:102900. doi: 10.1016/j.ejon.2025.102900. Epub 2025 May 10.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing interactive bibliotherapy and reading bibliotherapy in people with Emotional Distress and Pediatric Cancer, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
emotional distress (time frame: Changes from Baseline to Post-Intervention and 1-month follow-up.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05510635, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.