Hematological MalignanciesNCT00348959
An Evaluation of the Effect of 'Open Window' on Psychological Well-being and Experience of Stem Cell Transplantation
A study testing 'Open Window' Project in people with Hematological Malignancies, run by St. James's Hospital, Ireland at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Hematological Malignancies
- What is being tested?
- 'Open Window' Project
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 198 participants
- Where
- 1 siteIreland
- Study dates
- Aug 2006to Jan 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this 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
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
Read more
'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).
Read the detailed description
'Open Window' is a unique and novel intervention for patients being treated for haematological malignancies in the 'National Stem Cell Transplant Unit', St. James' Hospital, Dublin, Ireland. Treatment programmes include allogeneic and autologous stem cell transplantation for leukaemia and related disorders. This unit comprises 21 single air-conditioned rooms in which patients are treated and cared for. The unit is located on the ground floor of a large hospital and the view out of most of the windows is limited to the light railway system at best and the air conditioning unit at worst. Windows in the rooms are quite large although light and sunlight is limited in some by an adjacent building. The rooms vary in size and shape and all are en suite and contain a bed, locker, easy chair and TV/video mounted high on the wall, usually to the left, in front of the patient. All rooms are painted in magnolia with a blue door to the en suite and exit. In order to reduce the risk of infection, flowers and pictures hanging on the walls are prohibited and personal items such as photos are limited. Blinds are used on the windows and bed covers are blue, pink or green. The overall effect is minimalist and clinical due to the presence of medical equipment. Visiting is limited and children under 14 years of age are not allowed to visit.
Although a new unit, The National Transplant Unit was not purpose built and the focus of the design was in providing a protective environment for as many patients as possible within a limited space and with very specific requirements. While it is arguable that the introduction of colour to the walls and the inclusion of patterned curtains or bedspreads might enhance the environment from a design perspective, in the absence of such an initiative, this atmosphere provides an ideal opportunity to assess the effect of art on the experience of a very specific group of patients in a controlled atmosphere. Redshaw (2004) suggests that design alone does not provide spaces that are attractive, imaginative and engaging but that it is the inclusion of art that does this. Her study on the impact of the provision of art in a children's hospital is reported as providing a distraction for children and parents, providing enjoyment and comfort, facilitating self-expression and building self-esteem and confidence. This function of art in healthcare fulfills its role in providing a healing environment and is the primary reason why it was considered an appropriate intervention for the specific population of patients included in the 'Open Window' project.
People have a basic need for contact with each other. Isolation from people, or separation from familiar places, can cause feelings of despair, anger and hopelessness (Denton 1986; Jenner 1990; Gammon 1998). Views of nature or people through a window reduce the negative effects of isolation and can impact positively on psychological well-being (Kennedy \& Hamilton 1997, Ulrich 1983). Due to the location, design and décor of the rooms, the patients in 'The National Stem Cell Transplant Unit' at St. James's have very little stimulation other than TV, radio and reading. It is arguable that a patient-centred hospital environmental design may be sufficient to make their experience more comfortable and aesthetically pleasing; however, it is the inclusion of art in the environment that may provide a more positive and enduring distraction for patients and have a positive influence on a patient's sense of 'self' and well-being and overall psychological adjustment to having a life threatening illness. This is important in providing holistic care for patients and may influence their immediate and long-term recovery.
'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. The curator and artist in residence on the project can discuss with the patient and family, the possibility of obtaining familiar and/or family images if they wish. Patients can turn the system on, off and change the images by pressing the appropriate button on the remote control. They can also choose to include or exclude certain images if they wish. The volume of the music that accompanies some of the video channels can be controlled using the remote control.
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. The artist and theorist, Duchamp (1957, 3) described this process as the viewer "bringing the work in contact with the external world by deciphering and interpreting its inner qualification". These principles give patients who wish to use 'Open Window' the opportunity to become part of the creative process regardless of their past experience or knowledge of art. Patients may benefit because 'Open Window' becomes whatever they want it to be and helps them deal with their physical, psychological and social needs in a unique and individualized way.
The 'Open Window' Intervention has three aims. The first is to help patients deal with being in a restricted protective environment for 4-6 weeks. The second is to give patients a sense of connection with the outside world and the third is to provide a medium through which patients may reflect on having a life threatening illness, which may have immediate, and long-term effects on their psychological adjustment to recovering from and possibly surviving stem cell transplantation.
Results:
One hundred and ninty nine patients took part in the study, 96 were randomized to the intervention group and 103 to the control group. 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). Participants in the intervention group reported better experiences (P < 0.005). Qualitative data showed that those in the intervention group reported that 'Open Window' was a great distraction from their illness and isolation and provided a connection with outside 'normal' life.
- Conditions
- Hematological Malignancies
- Being tested
- 'Open Window' Project
- 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
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
'Open Window' ProjectBehavioural
Also called Art Intervention
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measures are Anxiety, Depression and Distress. Measures will be taken on 7 occasions over a six month period.
Measured: Six Months
Secondary outcomes (1)
Patient expectations in relation to the experience of having a stem cell transplant.
Measured: Day + 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2006 (estimated)
- Study startAug 2006
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hematological MalignanciesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. James's Hospital, Ireland
- Sponsor type
- University, hospital or other
- Collaborators
- Irish Cancer Society
- Responsible party
- Principal investigator, Catherine McCabe, St. James's Hospital, Ireland
- Investigators
- Shaun McCann, Study director, St. James's Hospital, IrelandCatherine McCabe, BNS, MSc, Principal investigator, University of Dublin, Trinity College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00348959
- Sponsor's protocol ID
- PSY04MCC
- Status last verified
- Jun 2012
- First submitted
- 5 Jul 2006
- Last updated
- 13 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22147646
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00348959
- Acronym / sponsor ID
- PSY04MCC
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- St. James's Hospital, IrelandUniversity, hospital or other
- Collaborators
- Irish Cancer Society
- Study start
- Aug 2006
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 6 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
'Open Window' is a unique and novel intervention for patients being treated for haematological malignancies in the 'National Stem Cell Transplant Unit', St. James' Hospital, Dublin, Ireland. Treatment programmes include allogeneic and autologous stem cell transplantation for leukaemia and related disorders. This unit comprises 21 single air-conditioned rooms in which patients are treated and cared for. The unit is located on the ground floor of a large hospital and the view out of most of the windows is limited to the light railway system at best and the air conditioning unit at worst. Windows in the rooms are quite large although light and sunlight is limited in some by an adjacent building. The rooms vary in size and shape and all are en suite and contain a bed, locker, easy chair and TV/video mounted high on the wall, usually to the left, in front of the patient. All rooms are painted in magnolia with a blue door to the en suite and exit. In order to reduce the risk of infection, flowers and pictures hanging on the walls are prohibited and personal items such as photos are limited. Blinds are used on the windows and bed covers are blue, pink or green. The overall effect is minimalist and clinical due to the presence of medical equipment. Visiting is limited and children under 14 years of age are not allowed to visit.
Although a new unit, The National Transplant Unit was not purpose built and the focus of the design was in providing a protective environment for as many patients as possible within a limited space and with very specific requirements. While it is arguable that the introduction of colour to the walls and the inclusion of patterned curtains or bedspreads might enhance the environment from a design perspective, in the absence of such an initiative, this atmosphere provides an ideal opportunity to assess the effect of art on the experience of a very specific group of patients in a controlled atmosphere. Redshaw (2004) suggests that design alone does not provide spaces that are attractive, imaginative and engaging but that it is the inclusion of art that does this. Her study on the impact of the provision of art in a children's hospital is reported as providing a distraction for children and parents, providing enjoyment and comfort, facilitating self-expression and building self-esteem and confidence. This function of art in healthcare fulfills its role in providing a healing environment and is the primary reason why it was considered an appropriate intervention for the specific population of patients included in the 'Open Window' project.
People have a basic need for contact with each other. Isolation from people, or separation from familiar places, can cause feelings of despair, anger and hopelessness (Denton 1986; Jenner 1990; Gammon 1998). Views of nature or people through a window reduce the negative effects of isolation and can impact positively on psychological well-being (Kennedy \& Hamilton 1997, Ulrich 1983). Due to the location, design and décor of the rooms, the patients in 'The National Stem Cell Transplant Unit' at St. James's have very little stimulation other than TV, radio and reading. It is arguable that a patient-centred hospital environmental design may be sufficient to make their experience more comfortable and aesthetically pleasing; however, it is the inclusion of art in the environment that may provide a more positive and enduring distraction for patients and have a positive influence on a patient's sense of 'self' and well-being and overall psychological adjustment to having a life threatening illness. This is important in providing holistic care for patients and may influence their immediate and long-term recovery.
'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. The curator and artist in residence on the project can discuss with the patient and family, the possibility of obtaining familiar and/or family images if they wish. Patients can turn the system on, off and change the images by pressing the appropriate button on the remote control. They can also choose to include or exclude certain images if they wish. The volume of the music that accompanies some of the video channels can be controlled using the remote control.
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. The artist and theorist, Duchamp (1957, 3) described this process as the viewer "bringing the work in contact with the external world by deciphering and interpreting its inner qualification". These principles give patients who wish to use 'Open Window' the opportunity to become part of the creative process regardless of their past experience or knowledge of art. Patients may benefit because 'Open Window' becomes whatever they want it to be and helps them deal with their physical, psychological and social needs in a unique and individualized way.
The 'Open Window' Intervention has three aims. The first is to help patients deal with being in a restricted protective environment for 4-6 weeks. The second is to give patients a sense of connection with the outside world and the third is to provide a medium through which patients may reflect on having a life threatening illness, which may have immediate, and long-term effects on their psychological adjustment to recovering from and possibly surviving stem cell transplantation.
Results:
One hundred and ninty nine patients took part in the study, 96 were randomized to the intervention group and 103 to the control group. 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). Participants in the intervention group reported better experiences (P < 0.005). Qualitative data showed that those in the intervention group reported that 'Open Window' was a great distraction from their illness and isolation and provided a connection with outside 'normal' life.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 'Open Window' ProjectAlso: Art InterventionOpen 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. | Behavioural | – |
Primary outcome
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
1 secondary outcome
Patient expectations in relation to the experience of having a stem cell transplant.
Time frame: Day + 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2012.
- Derived from this study: PubMed 22147646McCabe 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.
- Describes human connectedness as one of the concepts underpinning this interventionLink provided by the sponsor.
- Discusses how the 'Open Window' study demonstrates how art and science can be and possibly should be interlinkedLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shaun McCann study director
St. James's Hospital, Ireland
Catherine McCabe, BNS, MSc principal investigator
University of Dublin, Trinity College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 'Open Window' Project in people with Hematological Malignancies, run by St. James's Hospital, Ireland at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00348959, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2012.