NCT02363608

Brief 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. 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
146

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 5, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 16, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Last Updated

January 13, 2017

Status Verified

January 1, 2017

Enrollment Period

2 years

First QC Date

February 5, 2015

Last Update Submit

January 12, 2017

Conditions

Keywords

Canine-Assisted15-010post surgery patients

Outcome Measures

Primary Outcomes (2)

  • 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

    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.

    1 year

Study Arms (3)

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 programBehavioral: 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.

Behavioral: Caring Canine programBehavioral: baseline and post assessment

Interventions

standard post surgery care

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.

Caring Canines programstaff canine-assisted

The baseline and post assessment will include the Professional Quality of Life Scale (ProQOL R-IV) (Stamm, 1997-2005) and qualitative questions.

Caring Canines programstaff canine-assisted

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Staff and inpatients on the 15th floor.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

MeSH Terms

Interventions

BaseLine dental cement

Study Officials

  • Pamela Ginex, EdD, RN, OCN

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2015

First Posted

February 16, 2015

Study Start

January 1, 2015

Primary Completion

January 1, 2017

Last Updated

January 13, 2017

Record last verified: 2017-01

Locations