- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03969082
Evaluation of Bibliotherapy by Students and Patients With Cancer
Bibliotherapy, Students in Medicine and Health Sciences Read to Patients With Cancer During Treatment, an Evaluation by Patients and Students.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Bibliotherapy has been defined in different ways, but fundamentally means helping people through the use of books. In clinical contexts, it often refers to psychological self-help interventions that use treatment books [1]. However, other reading therapies exist, such as reading to patients during their treatment. Studies have demonstrated the positive effects of the use of reading in the treatment of patients such as increased self-awareness, empathy and hope and less negativity. The Reader, a British national charity, is the pioneer of a specific literature-based intervention i.e. shared reading. This approach is different from many reading therapies because it emphasizes on (1) reading aloud so that the book is a live presence and not an object of study (as is the case in educational settings) or a subject of chat (as in a book club) and on (2) literature (poetry and fiction) and its role in offering a model of human thinking and feeling. In the model of The Reader, small groups (2-12 people) come together weekly, to read novels, short stories and poetry together aloud. The target groups of The Reader are very diverse such as ordinary library visitors, vulnerable youth, rehabilitation groups in psychiatric hospitals, groups in prisons, prevention groups for stress and burnout, growth groups, personal etc.
This project, however, is unique in different ways. First, reading sessions will be organized in the hospital setting in a 1:1 relationship, as opposed to in small groups. Second, we will asses the possible impact of the intervention on emotional wellbeing and quality of life of patients with cancer, as well as on the student's professional development. This will be done by means of questionnaires (not as a quantitative study, but as a basis for the in-depth interview), diary notes, and an in-depth interview (student and patient separately and once together) .
The primary aim of this project is to assess the acceptability of this intervention. Specifically, this study seeks feedback on how well the reading sessions are received by the patients and the students. Secondly, we will assess if the sessions meet the needs of patients in their coping with cancer and help students in their professional development. To assess acceptability, in-depth interviews will be used and participants will be asked about their opinions regarding the reading sessions. We chose this particular interview type because it grants the interviewer flexibility to follow up with relevant questions and probes to gather richer information. The interviews will be recorded for transcription and analysis.
A call for participation for this study was made to students in Medicine and Health Sciences of Ghent University at a lecture of Jane Davis, the founder of The Reader. Students could submit their application; in total more than 50 applications were received. Three physicians (Dr. Helewaut, Dr. Pype and Dr. Kerre) independently scored the applications on the basis of motivation, background and age.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Oost-Vlaanderen
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Gent, Oost-Vlaanderen, Belgium, 9000
- Universitair Ziekenhuis Gent
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Patients
Inclusion Criteria:
- Clinical diagnosis of acute leukemia or advanced cancer of a solid tumor
- Treated at an inpatient ward (for patients with leukemia)
- Treated at inpatient ward ( for patients with solid tumor)
Exclusion Criteria:
- Patients under 18 years;
- Patients who are not able to read or understand Dutch.
Students:
- Student of the Faculty of Medicine and Health Sciences of Ghent University
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Bibliotherapy
Students will read to patients receiving active treatment using the "read aloud" method.
This will be performed in a 1: 1 relationship for half an hour for 8-10 times during a period of six months.
|
Students will read to patients during 30 minutes.
They will read aloud and pause regularly to encourage patients to reflect on what is being read, on the thoughts the poem or book has stirred or on how the reading matter relates to their own lives.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acceptability of the intervention
Time Frame: Interviews after six months of the first reading session
|
In-depth interview will be used to seek feedback on how well the reading session are received by the patients and the students
|
Interviews after six months of the first reading session
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Impact of the intervention
Time Frame: Questionnaires: baseline, 12 weeks and six months;
|
Impact on Quality of Life measured by the European Organisation for Research and Treatment of Cancer Quality of Life C30 questionnaire, score range 0-100, 100 is better score
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Questionnaires: baseline, 12 weeks and six months;
|
|
Impact of intervention in student by the use of in-depth interviews
Time Frame: In-depth interviews at 12 weeks and after six months of the first reading session
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Impact on professional development of students in Medicine and Health Sciences by performing in-depth interviews
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In-depth interviews at 12 weeks and after six months of the first reading session
|
|
Acceptability of the intervention
Time Frame: Interviews after 3 months of the first reading session
|
In-depth interview will be used to seek feedback on how well the reading session are received by the patients and the students
|
Interviews after 3 months of the first reading session
|
|
Effect on quality of life of patients
Time Frame: Questionnaires: baseline, 12 weeks and six months
|
Effect of quality of life with the McGill Quality of Life Scale, range 0-10, higher score is better score
|
Questionnaires: baseline, 12 weeks and six months
|
|
Effect on mood of patients
Time Frame: Questionnaires: baseline, 12 weeks and six months
|
Hospital Anxiety and Depression Scale, range 0-21, higher score is worse score
|
Questionnaires: baseline, 12 weeks and six months
|
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Effect on depression of patients
Time Frame: Questionnaires: baseline, 12 weeks and six months
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Patient Health Questionnaire-9, range 0-27, higher score is worse score
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Questionnaires: baseline, 12 weeks and six months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility of the intervention: Feedback based upon in-depth interviews organised
Time Frame: Interviews at 12 weeks after the first reading session
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Feedback based upon in-depth interviews organised
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Interviews at 12 weeks after the first reading session
|
|
Feasibility of the intervention by looking at number of reading sessions per dyad
Time Frame: Six months
|
Number of reading sessions organized
|
Six months
|
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Feasibility of the intervention measured with in-depth interviews
Time Frame: Interviews after six months of the first reading session
|
Feedback based upon in-depth interviews organised
|
Interviews after six months of the first reading session
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tessa Kerre, PhD, Department of Hematology, Ghent University Hospital
- Study Chair: Vibbeke Kruse, PhD, Department of Medical Oncology/ Cancer Center, Ghent University Hospital
- Study Chair: Peter Pype, PhD, Department of Public Health and Primary Care, Ghent University
- Study Chair: Fleur Helewaut, Clinical Skills Training Centre, Ghent University
- Study Chair: Jan Raes, Founder, Het Lezerscollectief
Publications and helpful links
General Publications
- Malibiran R, Tariman JD, Amer K. Bibliotherapy: Appraisal of Evidence for Patients Diagnosed With Cancer. Clin J Oncol Nurs. 2018 Aug 1;22(4):377-380. doi: 10.1188/18.CJON.377-380.
- Davis J. Enjoying and enduring: groups reading aloud for wellbeing. Lancet. 2009 Feb 28;373(9665):714-5. doi: 10.1016/s0140-6736(09)60426-8. No abstract available.
- Korner A, Roberts N, Steele RJ, Brosseau DC, Rosberger Z. A randomized controlled trial assessing the efficacy of a self-administered psycho-educational intervention for patients with cancer. Patient Educ Couns. 2019 Apr;102(4):735-741. doi: 10.1016/j.pec.2018.12.002. Epub 2018 Dec 3.
- Billington J, Farrington G, Lampropoulou S, Lingwood J, Jones A, Ledson J, McDonnell K, Duirs N, Humphreys AL. A comparative study of cognitive behavioural therapy and shared reading for chronic pain. Med Humanit. 2017 Sep;43(3):155-165. doi: 10.1136/medhum-2016-011047. Epub 2016 Dec 9.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- BC-4703
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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