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出境医 / 临床实验 / Evaluation of Bibliotherapy by Students and Patients With Cancer

Evaluation of Bibliotherapy by Students and Patients With Cancer

Study Description
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.

Condition or disease Intervention/treatment Phase
Acute Leukemia Advanced Solid Tumor Behavioral: Bibliotherapy Not Applicable

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 Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Bibliotherapy, Students in Medicine and Health Sciences Read to Patients With Cancer During Treatment, an Evaluation by Patients and Students.
Actual Study Start Date : March 9, 2019
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : March 1, 2024
Arms and Interventions
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.
 Behavioral: Bibliotherapy
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.
Outcome Measures
Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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 ]
    Impact on professional development of students in Medicine and Health Sciences by performing in-depth interviews

  3. 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

  4. 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

  5. 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

  6. Effect on depression of patients [ Time Frame: Questionnaires: baseline, 12 weeks and six months ]
    Patient Health Questionnaire-9, range 0-27, higher score is worse score


Other Outcome Measures:
  1. Feasibility of the intervention: Feedback based upon in-depth interviews organised [ Time Frame: Interviews at 12 weeks after the first reading session ]
    Feedback based upon in-depth interviews organised

  2. Feasibility of the intervention by looking at number of reading sessions per dyad [ Time Frame: Six months ]
    Number of reading sessions organized

  3. 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


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Contacts and Locations

Contacts
Layout table for location contacts
Contact: Gaëlle Vanbutsele, PhD 003293320879 gaelle.vanbutsele@uzgent.be
Contact: Kim Eecloo, MSc 003293320791 kim.eecloo@uzgent.be

Locations
Layout table for location information
Belgium
Universitair Ziekenhuis Gent Recruiting
Gent, Oost-Vlaanderen, Belgium, 9000
Contact: Gaëlle Vanbutsele, PhD    003293320879    gaelle.vanbutsele@uzgent.be   
Contact: Kim Eecloo, MSc    003293320791    kim.eecloo@uzgent.be   
Principal Investigator: Tessa Kerre, MD, PhD         
Sponsors and Collaborators
University Hospital, Ghent
University Ghent
Het Lezerscollectief
Investigators
Layout table for investigator information
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
Tracking Information
First Submitted Date  ICMJE April 24, 2019
First Posted Date  ICMJE May 31, 2019
Last Update Posted Date May 31, 2019
Actual Study Start Date  ICMJE March 9, 2019
Estimated Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 28, 2019) 		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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 28, 2019)
  • 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
  • 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 ]
    Impact on professional development of students in Medicine and Health Sciences by performing in-depth interviews
  • 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
  • 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
  • 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
  • Effect on depression of patients [ Time Frame: Questionnaires: baseline, 12 weeks and six months ]
    Patient Health Questionnaire-9, range 0-27, higher score is worse score
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 28, 2019)
  • Feasibility of the intervention: Feedback based upon in-depth interviews organised [ Time Frame: Interviews at 12 weeks after the first reading session ]
    Feedback based upon in-depth interviews organised
  • Feasibility of the intervention by looking at number of reading sessions per dyad [ Time Frame: Six months ]
    Number of reading sessions organized
  • 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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Evaluation of Bibliotherapy by Students and Patients With Cancer
Official Title  ICMJE Bibliotherapy, Students in Medicine and Health Sciences Read to Patients With Cancer During Treatment, an Evaluation by Patients and Students.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Acute Leukemia
  • Advanced Solid Tumor
Intervention  ICMJE Behavioral: Bibliotherapy
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.
Study Arms  ICMJE 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.
Intervention: Behavioral: Bibliotherapy
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. Review.
  • Davis J. Enjoying and enduring: groups reading aloud for wellbeing. Lancet. 2009 Feb 28;373(9665):714-5.
  • Körner 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 28, 2019) 		40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 1, 2024
Estimated Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Gaëlle Vanbutsele, PhD 003293320879 gaelle.vanbutsele@uzgent.be
Contact: Kim Eecloo, MSc 003293320791 kim.eecloo@uzgent.be
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03969082
Other Study ID Numbers  ICMJE 2019/0183
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Ghent
Study Sponsor  ICMJE University Hospital, Ghent
Collaborators  ICMJE
  • University Ghent
  • Het Lezerscollectief
Investigators  ICMJE
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
PRS Account University Hospital, Ghent
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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