Clinical trial · Interventional
An Evaluation of the Effect of 'Open Window' on Psychological Well-being and Experience of Stem Cell Transplantation
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematological Malignancies | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 'Open Window' Project | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- The primary outcome measures are Anxiety, Depression and Distress. Measures will be taken on 7 occasions over a six month period.
- timeFrame
- Six Months
Secondary outcomes (1)
- measure
- Patient expectations in relation to the experience of having a stem cell transplant.
- timeFrame
- Day + 30
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDMcCabe 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