An Evaluation of the Effect of 'Open Window' on Psychological Well-being and Experience of Stem Cell Transplantation
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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 |
- 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 ]
- 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) |
-
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.
Show Detailed Description Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| Ireland | |
| St. James's Hospital | |
| Dublin, Ireland, 8 | |
| 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 May 21, 2013