An Evaluation of the Effect of 'Open Window' on Psychological Well-being and Experience of Stem Cell Transplantation

This study has been completed.
Sponsor:
Collaborator:
Irish Cancer Society
Information provided by (Responsible Party):
Catherine McCabe, St. James's Hospital
ClinicalTrials.gov Identifier:
NCT00348959
First received: July 5, 2006
Last updated: June 12, 2012
Last verified: June 2012
  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 is being 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.

Results:

Of the 199 patients in the study, 96 were randomized to the intervention group and 103 to the control group. Participants in the intervention group had significantly reduced levels of anxiety on the day before transplant (P = 0.001), at day 7 (P = 0.041), and day 60 (P = 0.035). There was a significant reduction in depression before transplant (P= 0.022). Participants in the intervention group reported better experiences (P < 0.005).


Condition Intervention
Hematological Malignancies
Behavioral: 'Open Window' Project

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • The primary outcome measures are Anxiety, Depression and Distress. Measures will be taken on 7 occasions over a six month period. [ Time Frame: Six Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient expectations in relation to the experience of having a stem cell transplant. [ Time Frame: Day + 30 ] [ Designated as safety issue: No ]

Enrollment: 198
Study Start Date: August 2006
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: 'Open Window' Project

    Open Window' is an entirely art based intervention comprising a multimedia system that uses a combination of video projectors, audio speakers and bespoke software to make images appear as a 'virtual window' on the wall of the patients' room. Artists use mobile phone cameras and camcorders to record the images that are sent to the unit over the internet and via mobile phone networks. Original music composed for the project may also accompany the images as they appear.

    Artists are commissioned to create work for the 'Open Window' project and are aware of the nature of the viewer and the context in which the art will be shown. The art in 'Open Window' encourages the viewer to think about and engage in what they see from their own personal frame of reference.

    Other Name: Art Intervention
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients admitted to the Denis Burkitt unit for an autologous or allogeneic stem cell transplant.

Patients who gives informed consent to participate in the study Patients who can read and speak English reasonably well. Patients who do not have communication difficulties, intellectual disabilities or known mental illness Patients who 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 Patients who do not consent to participate in the study Patients with communication difficulties, learning disabilities, mental illness, prisoners, young offenders.

Patients who are transferred to other units immediately following transplantation

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00348959

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

Additional Information:
No publications provided by St. James's Hospital, Ireland

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Catherine McCabe, Research Fellow, St. James's Hospital
ClinicalTrials.gov Identifier: NCT00348959     History of Changes
Other Study ID Numbers: PSY04MCC
Study First Received: July 5, 2006
Last Updated: June 12, 2012
Health Authority: Ireland: Medical Ethics Research Committee

Keywords provided by St. James's Hospital, Ireland:
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

Additional relevant MeSH terms:
Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Hematologic Diseases

ClinicalTrials.gov processed this record on September 18, 2014