NCT03969082

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 9, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 31, 2019

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

April 17, 2024

Status Verified

April 1, 2024

Enrollment Period

5 years

First QC Date

April 24, 2019

Last Update Submit

April 16, 2024

Conditions

Keywords

BibliotherapyCancer

Outcome Measures

Primary Outcomes (1)

  • Acceptability of the intervention

    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 Outcomes (6)

  • Impact of the intervention

    Questionnaires: baseline, 12 weeks and six months;

  • Impact of intervention in student by the use of in-depth interviews

    In-depth interviews at 12 weeks and after six months of the first reading session

  • Acceptability of the intervention

    Interviews after 3 months of the first reading session

  • Effect on quality of life of patients

    Questionnaires: baseline, 12 weeks and six months

  • Effect on mood of patients

    Questionnaires: baseline, 12 weeks and six months

  • +1 more secondary outcomes

Other Outcomes (3)

  • Feasibility of the intervention: Feedback based upon in-depth interviews organised

    Interviews at 12 weeks after the first reading session

  • Feasibility of the intervention by looking at number of reading sessions per dyad

    Six months

  • Feasibility of the intervention measured with in-depth interviews

    Interviews after six months of the first reading session

Study Arms (1)

Bibliotherapy

EXPERIMENTAL

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

Interventions

BibliotherapyBEHAVIORAL

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.

Bibliotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitair Ziekenhuis Gent

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

Related Publications (4)

  • 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.

    PMID: 30035795BACKGROUND
  • 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.

    PMID: 19263586BACKGROUND
  • 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.

MeSH Terms

Conditions

Neoplasms

Interventions

Bibliotherapy

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Tessa Kerre, PhD

    Department of Hematology, Ghent University Hospital

    PRINCIPAL INVESTIGATOR
  • 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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2019

First Posted

May 31, 2019

Study Start

March 9, 2019

Primary Completion

March 1, 2024

Study Completion

March 1, 2024

Last Updated

April 17, 2024

Record last verified: 2024-04

Locations