- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02363608
Animal Assisted Activity Program on Patients and Staff on an Inpatient Surgical Oncology Unit
January 12, 2017 updated by: Memorial Sloan Kettering Cancer Center
Caring Canines: Outcomes From an Animal Assisted Activity Program on Patients and Staff on an Inpatient Surgical Oncology Unit
The purpose of this study is to describe the effects of canine-assisted activity visits on patients and staff in a hospital setting.
The Caring Canines program uses dogs who have been trained to be obedient, calm and comforting.
It involves a visit by a volunteer (called the dog's handler) and the volunteer's dog that has been trained and tested to have a good personality and to follow commands.
A visit typically lasts about 10-15 minutes with the patient interacting with the dog while the dog is supervised by the handler.
Memorial Sloan Kettering currently has Caring Canine dogs visit patients but the investigators don't yet know the impact of these visits on patients and staff.
The investigators would like to see how the Caring Canine visits impact a patients' mood, including anxiety, stress, and sense of well-being.
Two groups of patients will take part in this study - the first group will receive standard post surgery care and will not receive a visit from the Caring Canines program and the second group will receive daily visits (Tuesday -Friday) from the Caring Canines program while they are on M15.
The purpose of this study is to look at differences in well-being between patients who have the visits with the dogs and patients who do not.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
146
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Staff and inpatients on the 15th floor.
Description
Inclusion Criteria:
Patients
- Age greater than 21
- Admitted to M15 following a Monday or Tuesday surgery
- Ability to speak and read English.
Staff
- Age greater than 21
- Works at least one day shift a week on M15
- Ability to speak and read English
Exclusion Criteria:
Patients
- Self reported allergy to dogs
- Medical need to be in an isolation room
- Medical need to be in a Protective Environment room .
Staff
- Self reported allergy to dogs
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
standard post surgery care
An initial cohort of consecutive patients admitted to the 15th floor of the hospital on a Monday or Tuesday will form the usual care control arm of the study.
Once this cohort is completed, the Caring Canines program will start.
|
|
Caring Canines program
Once the standard of care cohort is completed, the Caring Canines program will start making visits on the 15th floor and a second cohort of consecutive patients admitted to M15 on a Monday or Tuesday will form the intervention (experimental) arm of the study.patients
admitted to M15 on a Monday or Tuesday will form the intervention (experimental) arm of the study.
|
The therapy dogs who visit at MSKCC.
A visit by a therapy dog typically lasts about 10-15 minutes with the patient interacting with the therapy dog while the dog is supervised by the handler.
The baseline and post assessment will include the Professional Quality of Life Scale (ProQOL R-IV) (Stamm, 1997-2005) and qualitative questions.
|
staff canine-assisted
For the staff portion of this study a longitudinal pre and post intervention design will be used.
Baseline staff assessments will occur prior to the Caring Canine program being implemented on the unit.
The assessments include questions about compassion satisfaction and compassion fatigue as well as some open ended questions about your thoughts on the Caring Canines program.
Post assessment will occur after the program has been active on the unit for at least 6 weeks.
Only staff who work at least one Monday - Friday day shift each week will be eligible to participate.
|
The therapy dogs who visit at MSKCC.
A visit by a therapy dog typically lasts about 10-15 minutes with the patient interacting with the therapy dog while the dog is supervised by the handler.
The baseline and post assessment will include the Professional Quality of Life Scale (ProQOL R-IV) (Stamm, 1997-2005) and qualitative questions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change from baseline in the follow-up PHQ-4 scores
Time Frame: 1 year
|
The PHQ-4 is an ultra-brief self-report questionnaire that consists of a 2-item depression scale and a 2 item anxiety scale.
Among the control and intervention groups to assess psychological effects of the program.
Responses on the pain scale will assess physiological effects, and responses on the open-ended questions will identify patient-perceived benefits of the program
|
1 year
|
difference in baseline and follow-up ProQOL scores (For Staff)
Time Frame: 1 year
|
(Compassion Satisfaction score and Burnout score) to assess change in work satisfaction due to the program, and responses on the qualitative questions will address staff-perceived benefits of the program.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2015
Primary Completion (Actual)
January 1, 2017
Study Registration Dates
First Submitted
February 5, 2015
First Submitted That Met QC Criteria
February 9, 2015
First Posted (Estimate)
February 16, 2015
Study Record Updates
Last Update Posted (Estimate)
January 13, 2017
Last Update Submitted That Met QC Criteria
January 12, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 15-010
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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