Health Status UnknownNCT03688945
Art in Improving Outcomes in Participants Undergo Surgery
A study testing Art Therapy, Best Practice and Questionnaire Administration in people with Health Status Unknown, run by Roswell Park Cancer Institute at 1 site in United States.
Trial summary
This trial studies how well art works in improving outcomes in participants who are undergoing surgery. Exposure to art may help to improve clinical and psychological outcomes. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Health Status Unknown
- What is being tested?
- Art Therapy, Best Practice and Questionnaire Administration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2017to 27 Nov 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Ambulant inpatients that will stay for at least 2 days postoperatively and do not require continuous monitoring
- All races and ethnic groups are eligible for this study
Who cannot join
- Patients with altered mental status, psychiatric illness, debilitating pain, blind patients, or those who require continuous monitoring postoperatively will be excluded from the study
- Adult unable to consent, individuals who are not yet adults, pregnant women or prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
Roswell Park Cancer Institute
Buffalo, New York, 14263
About this study
Official title: Art Heals - (the Effects of Art After Robot Assisted Surgery)
This trial studies how well art works in improving outcomes in participants who are undergoing surgery. Exposure to art may help to improve clinical and psychological outcomes.
Read the detailed description
PRIMARY OBJECTIVES:
- Investigate through evidence-based randomized controlled trial the effect of exposure to art during the perioperative period on the outcome of surgical outcomes II. Assess patient response to artwork and investigate the correlation of patient response with the clinical outcomes of the patients.
III. Measure cognitive changes that may occur for patients based on art exposure.
OUTLINE: Participants are randomized into 1 of 2 arms.
ARM I: Participants attend at least 2 sessions of viewing art pieces over 15 minutes every day for 2 years.
ARM II: Participants receive standard of care for 2 years.
- Conditions
- Health Status Unknown
- Being tested
- Art Therapy, Best Practice, Questionnaire Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Art TherapyProcedure or surgery
Attend art viewing sessions
Best PracticeOther
Also called standard of care, standard therapy
Receive standard of care
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (art sessions) | Experimental | Participants attend at least 1 session of viewing art pieces over 15 minutes every day for 2 years. Receives: Procedure: Art Therapy; Other: Questionnaire Administration |
| Arm II (standard of care) | Active comparator | Participants receive standard of care for 2 years. Receives: Other: Best Practice; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mental health wellbeing score
Will be assessed by using a Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS). This is a 14 item scale with 5 response categories that cover both feeling and functioning aspects of mental wellbeing.
Measured: Up to 2 years
Secondary outcomes (5)
Reduced pain: NRS
Will assess by using a validated visual numeric rating scale - corresponding to pain experienced over 24 hours
Measured: Up to 2 years
Anxiety score (patient)
Will be assessed by using State Trait Inventory for Adults (STAI). - A self reporting survey which measures anxiety.
Measured: Up to 2 years
Hope score
Will be assessed by using Herth Hope Index. A 12 item self reporting questionnaire measuring the sense of hope.
Measured: Up to 2 years
Change in blood pressure
Will assess systolic and diastolic pressure . Parameters will be collected from the patient chart
Measured: Up to 2 years
change in recovery of bowel function
Evaluated using Parameters collected from the patient chart
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2018
- Study start7 Aug 2017
- Primary completion27 Nov 2019
- Study completion27 Nov 2019
Why it stopped: Art gallery dissembled- no research goals with new art.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Status UnknownStudies of the same condition, open and under way.
- More trials run by Roswell Park Cancer InstituteThe sponsor's other registered studies.
- 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Khurshid Guru, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03688945
- Sponsor's protocol ID
- I 43217
- Other IDs
- NCI-2018-00457, I 43217
- Status last verified
- Jul 2022
- First submitted
- 19 Sep 2018
- Last updated
- 25 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Art Heals - (the Effects of Art After Robot Assisted Surgery)
- ClinicalTrials.gov ID
- NCT03688945
- Acronym / sponsor ID
- I 43217
- Conditions
- Health Status Unknown
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Art gallery dissembled- no research goals with new art.
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- 7 Aug 2017 (actual)
- Primary completion
- 27 Nov 2019 (actual)
- Study completion
- 27 Nov 2019 (actual)
- First posted
- 28 Sep 2018 (actual)
- 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.
This trial studies how well art works in improving outcomes in participants who are undergoing surgery. Exposure to art may help to improve clinical and psychological outcomes.
Detailed description
PRIMARY OBJECTIVES:
- Investigate through evidence-based randomized controlled trial the effect of exposure to art during the perioperative period on the outcome of surgical outcomes II. Assess patient response to artwork and investigate the correlation of patient response with the clinical outcomes of the patients.
III. Measure cognitive changes that may occur for patients based on art exposure.
OUTLINE: Participants are randomized into 1 of 2 arms.
ARM I: Participants attend at least 2 sessions of viewing art pieces over 15 minutes every day for 2 years.
ARM II: Participants receive standard of care for 2 years.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (art sessions) | Experimental | Procedure: Art Therapy, Other: Questionnaire AdministrationParticipants attend at least 1 session of viewing art pieces over 15 minutes every day for 2 years. |
| Arm II (standard of care) | Active comparator | Other: Best Practice, Other: Questionnaire AdministrationParticipants receive standard of care for 2 years. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Ambulant inpatients that will stay for at least 2 days postoperatively and do not require continuous monitoring
- All races and ethnic groups are eligible for this study
Key exclusion criteria (2 listed)
- Patients with altered mental status, psychiatric illness, debilitating pain, blind patients, or those who require continuous monitoring postoperatively will be excluded from the study
- Adult unable to consent, individuals who are not yet adults, pregnant women or prisoners
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 |
|---|---|---|
| Art TherapyAttend art viewing sessions | Procedure or surgery | Arm I (art sessions) |
| Best PracticeAlso: standard of care, standard therapyReceive standard of care | Other | Arm II (standard of care) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (art sessions), Arm II (standard of care) |
Primary outcome
Mental health wellbeing score
Time frame: Up to 2 years
Will be assessed by using a Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS). This is a 14 item scale with 5 response categories that cover both feeling and functioning aspects of mental wellbeing.
5 secondary outcomes
Reduced pain: NRS
Time frame: Up to 2 years
Anxiety score (patient)
Time frame: Up to 2 years
Hope score
Time frame: Up to 2 years
Change in blood pressure
Time frame: Up to 2 years
change in recovery of bowel function
Time frame: Up to 2 years
Results and safety
The study was stopped early (reason given: Art gallery dissembled- no research goals with new art.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2022.
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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.
Khurshid Guru principal investigator
Roswell Park Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Art Therapy, Best Practice and Questionnaire Administration in people with Health Status Unknown, run by Roswell Park Cancer Institute at 1 site in United States.
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: stopped early, as of the sponsor's last update on 25 Jul 2022. 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 United States. 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 was stopped early (reason given: Art gallery dissembled- no research goals with new art.). Results are not available in the source record.
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?
Mental health wellbeing score (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jul 2022.