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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • United States
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.
Behavioral: Caring Canine program
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.
Behavioral: baseline and post assessment
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.
Behavioral: Caring Canine program
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.
Behavioral: baseline and post assessment
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Memorial Sloan Kettering Cancer Center

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 5, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 16, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 13, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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