Clinical trial NCT03969082: Evaluation of Bibliotherapy by Students and Patients With Cancer
Official title: Bibliotherapy, Students in Medicine and Health Sciences Read to Patients With Cancer During Treatment, an Evaluation by Patients and Students.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Leukemia
Advanced Solid Tumor
Keywords: Bibliotherapy
Cancer
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: University Ghent
name: Het Lezerscollectief
First posted: 2019-05-31
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Research has demonstrated the positive effects of bibliotherapy (the use of reading in the treatment of patients), such as increased self-awareness, increased empathy, hope and decreased negativity. At Ghent University Hospital, 20 students from the Faculty of Medicine and Health Sciences were selected to be trained as readers by 'The Readers Collective', a Flemish Organization inspired by The Reader. Those students will read to patients with acute leukemia or to patients with a solid tumors in an advanced stage, using the "read aloud" method. Eight to ten reading sessions of approximately half an hour will be organized in a 1: 1 relationship between student and patient during a period of six months. The primary aim of study is to determine the acceptability and feasibility of the intervention by the patients as well as the students. Secondary aims are exploring the impact of the reading sessions on the professional development of the students and on the emotional well-being and quality of life of cancer patients. Assessment will be based upon questionnaires (as a basis for the in-depth interviews), diary notes, and in-depth interviews.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Acceptability of the intervention
timeFrame: Interviews after six months of the first reading session
Secondary outcomes:
measure: Impact of the intervention
timeFrame: Questionnaires: baseline, 12 weeks and six months;
measure: Impact of intervention in student by the use of in-depth interviews
timeFrame: In-depth interviews at 12 weeks and after six months of the first reading session
measure: Acceptability of the intervention
timeFrame: Interviews after 3 months of the first reading session
measure: Effect on quality of life of patients
timeFrame: Questionnaires: baseline, 12 weeks and six months
measure: Effect on mood of patients
timeFrame: Questionnaires: baseline, 12 weeks and six months
measure: Effect on depression of patients
timeFrame: Questionnaires: baseline, 12 weeks and six months
Other outcomes:
measure: Feasibility of the intervention: Feedback based upon in-depth interviews organised
timeFrame: Interviews at 12 weeks after the first reading session
measure: Feasibility of the intervention by looking at number of reading sessions per dyad
timeFrame: Six months
measure: Feasibility of the intervention measured with in-depth interviews
timeFrame: Interviews after six months of the first reading session
Locations:
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
state: Oost-Vlaanderen
Study officials:
affiliation: Department of Hematology, Ghent University Hospital
name: Tessa Kerre, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Medical Oncology/ Cancer Center, Ghent University Hospital
name: Vibbeke Kruse, PhD
role: STUDY_CHAIR
affiliation: Department of Public Health and Primary Care, Ghent University
name: Peter Pype, PhD
role: STUDY_CHAIR
affiliation: Clinical Skills Training Centre, Ghent University
name: Fleur Helewaut
role: STUDY_CHAIR
affiliation: Founder, Het Lezerscollectief
name: Jan Raes
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.