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

NCT00348959 | Completed

• 1 other identifier: PSY04MCC
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Hematological Malignancies

Keywords

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

Outcome Measures

Primary Outcomes (1)

• The primary outcome measures are Anxiety, Depression and Distress. Measures will be taken on 7 occasions over a six month period.

  Six Months

Secondary Outcomes (1)

• Patient expectations in relation to the experience of having a stem cell transplant.

  Day + 30

Interventions

'Open Window' Project BEHAVIORAL

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.

Also known as: Art Intervention

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• St. James's Hospital, Ireland: lead
• Irish Cancer Society: collaborator

Study Sites (1)

St. James's Hospital

Dublin, Dublin, 8, Ireland

Location

Related Publications (1)

• McCabe C, Roche D, Hegarty F, McCann S. 'Open Window': a randomized trial of the effect of new media art using a virtual window on quality of life in patients' experiencing stem cell transplantation. Psychooncology. 2013 Feb;22(2):330-7. doi: 10.1002/pon.2093. Epub 2011 Dec 6.

  PMID: 22147646 DERIVED

Related Links

• Describes human connectedness as one of the concepts underpinning this intervention
• Discusses how the 'Open Window' study demonstrates how art and science can be and possibly should be interlinked

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Shaun McCann

  St. James's Hospital, Ireland

  STUDY DIRECTOR

• Catherine McCabe, BNS, MSc

  University of Dublin, Trinity College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Fellow

Study Record Dates

• First Submitted: July 5, 2006
• First Posted: July 6, 2006
• Study Start: August 1, 2006
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: June 13, 2012

Record last verified: 2012-06

Locations

IE (1)