Postoperative CareNCT02363608
Animal Assisted Activity Program on Patients and Staff on an Inpatient Surgical Oncology Unit
An observational study of Postoperative Care, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postoperative Care
- What is being tested?
- standard post surgery care, Caring Canine program and baseline and post assessment
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- How many people
- 146 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Jan 2017
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Staff and inpatients on the 15th floor.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: 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.
- Conditions
- Postoperative Care
- Being tested
- standard post surgery care, Caring Canine program, baseline and post assessment
- Keywords
- Canine-Assisted, 15-010, post surgery patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard post surgery careOther
Caring Canine programBehavioural
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.
baseline and post assessmentBehavioural
The baseline and post assessment will include the Professional Quality of Life Scale (ProQOL R-IV) (Stamm, 1997-2005) and qualitative questions.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: standard post surgery care | |
| 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. Receives: Behavioral: Caring Canine program; Behavioral: baseline and post assessment | |
| 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. Receives: Behavioral: Caring Canine program; Behavioral: baseline and post assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline in the follow-up PHQ-4 scores
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
Measured: 1 year
difference in baseline and follow-up ProQOL scores (For Staff)
(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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2015 (estimated)
- Study startJan 2015
- Primary completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative CareStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pamela Ginex, EdD, RN, OCN, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02363608
- Sponsor's protocol ID
- 15-010
- Status last verified
- Jan 2017
- First submitted
- 5 Feb 2015
- Last updated
- 13 Jan 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caring Canines: Outcomes From an Animal Assisted Activity Program on Patients and Staff on an Inpatient Surgical Oncology Unit
- ClinicalTrials.gov ID
- NCT02363608
- Acronym / sponsor ID
- 15-010
- Conditions
- Postoperative Care
- Keywords
- Canine-Assisted, 15-010, post surgery patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jan 2017 (actual)
- First posted
- 16 Feb 2015 (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 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| standard post surgery care | – | Other: standard post surgery careAn 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 | – | Behavioral: Caring Canine program, Behavioral: baseline and post assessmentOnce 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. |
| staff canine-assisted | – | Behavioral: Caring Canine program, Behavioral: baseline and post assessmentFor 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Staff and inpatients on the 15th floor.
Key inclusion criteria (8 listed)
- Patients
- Age greater than 21
- Admitted to M15 following a Monday or Tuesday surgery
- Ability to speak and read English.
- Staff
Key exclusion criteria (6 listed)
- Patients
- Self reported allergy to dogs
- Medical need to be in an isolation room
- Medical need to be in a Protective Environment room .
- Staff
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 |
|---|---|---|
| standard post surgery care | Other | standard post surgery care |
| Caring Canine programThe 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. | Behavioural | Caring Canines program, staff canine-assisted |
| baseline and post assessmentThe baseline and post assessment will include the Professional Quality of Life Scale (ProQOL R-IV) (Stamm, 1997-2005) and qualitative questions. | Behavioural | Caring Canines program, staff canine-assisted |
Primary outcome
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
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.
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 Jan 2017.
- Memorial Sloan Kettering Cancer CenterLink 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.
Pamela Ginex, EdD, RN, OCN principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Care, run by Memorial Sloan Kettering Cancer Center 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 8 inclusion and 6 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 Jan 2017. 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 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?
change from baseline in the follow-up PHQ-4 scores (time frame: 1 year). The study lists 2 primary outcomes in all. 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 13 Jan 2017.