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An Evaluation of the Effect of ‘Open Window’ on Psychological Well-Being and Experience of Stem Cell Transplantation
This study is not yet open for participant recruitment.
Verified by St. James's Hospital, June 2006
Sponsors and Collaborators: St. James's Hospital
Irish Cancer Society
Information provided by: St. James's Hospital
ClinicalTrials.gov Identifier: NCT00348959
  Purpose

The 'Open Window' Study is a prospective longitudinal study using a 4 group randomised control trial design to evaluate the psychological effect of ‘Open Window’ on the consequences of long term isolation on patients undergoing stem cell transplantation treatment of haematological malignancies. This study uses a randomised control trial design, which is widely used in healthcare settings to test the effects of interventions and testing cause and effect relationships between variables. A mixed methods approach for data collection and data analysis will be used. This will facilitate measurement of patients’ psychological response to ‘Open Window’ using questionnaires and exploration of subjective feelings in relation to personal experiences of having a stem cell transplant through semi structured interviews.

Hypothesis to be tested

‘Open Window’ has no effect on patients’ levels of anxiety, depression, or distress when undergoing a stem cell transplant.


Condition Intervention
Hematological Malignancies
 Behavioral: 'Open window'

MedlinePlus related topics: Cancer Depression
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: An Evaluation of the Effect of ‘Open Window’, an Art Intervention, on Psychological Well-Being and Experience of Stem Cell Transplantation for the Treatment of Haematological Malignancies

Further study details as provided by St. James's Hospital:

Primary Outcome Measures:
  • The primary outcome measures are Anxiety, Depression and Distress. Measures will be taken on 7 occasions over a six month period.
  • Details are as follows:
  • T1 Day of admission
  • T2 (day-1)Day before stem cell transplantation
  • T3 (day+7)One week post transplant
  • T4 (day+18 for allogenic transplants)
  • (day+15 for autologous transplants)
  • T5 (day+60)Approximately 6 weeks post transplant
  • T6 (day+100)Approximately 3 months post transplant
  • T7 6 months post transplant

Secondary Outcome Measures:
  • Patient expectations in relation to the experience of having a stem cell transplant.

Estimated Enrollment: 400
Estimated Study Completion Date: June 2010
  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Any patient admitted to the Denis Burkitt unit for an autologous or allogeneic stem cell transplant.
  • Any patient who gives informed consent to participate in the study
  • Can read and speak English reasonably well.
  • Does not have communication difficulties, intellectual disabilities or known mental illness
  • Will be treated as an in-patient in the Denis Burkitt Unit following transplantation.

Exclusion Criteria:

  • Patients who are not undergoing a stem cell transplant
  • Any patient who does not consent to participate in the study
  • Any patient with communication difficulties, learning disabilities, mental illness, prisoners, young offenders.
  • Patients who have experienced ‘Open Window’ on a prior admission.
  • Patients who are transferred to other units immediately following transplantation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00348959

Contacts
Contact: Catherine McCabe, BNS, MSc +353 1 896 2692 ext 3019 camccabe@tcd.ie
Contact: Shaun McCann +353 1 896 3236 smccann@stjames.ie

Locations
Ireland
St. James's Hospital
Dublin, Ireland, 8
Sponsors and Collaborators
St. James's Hospital
Irish Cancer Society
Investigators
Study Director: Shaun McCann St. James's Hospital
Principal Investigator: Catherine McCabe, BNS, MSc St. James's Hospital
  More Information

Describes human connectedness as one of the concepts underpinning this intervention  This link exits the ClinicalTrials.gov site
Discusses how the 'Open Window' study demonstrates how art and science can be and possibly should be interlinked  This link exits the ClinicalTrials.gov site
Website of the Haematology Association of Ireland, Nurses Group. Newsletter includes a summary of the 'Open Window' Project and Study, Published June 2005  This link exits the ClinicalTrials.gov site
Official website for the 'Open Window' Project  This link exits the ClinicalTrials.gov site

Study ID Numbers: PSY04MCC
Study First Received: July 5, 2006
Last Updated: November 29, 2006
ClinicalTrials.gov Identifier: NCT00348959  
Health Authority: Ireland: Medical Ethics Research Committee

Keywords provided by St. James's Hospital:
Haematological Malignancies
Autologous Stem Cell Transplantation
Allogeneic Stem Cell Transplantation
Quality of Life
 Life Threatening Illness
Art in Health Care
Randomised Controlled Trial
Mixed Methods Research

Study placed in the following topic categories:
Hematologic Neoplasms
Hematologic Diseases
Quality of Life

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 14, 2009



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