Back to resultsWaitlist-controlled Trial of a Psychological Education Program for Nurses
Primary Purpose
Psychological Stress
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Psychological education program for nurses
Sponsored by
About this trial
This is an interventional supportive care trial for Psychological Stress focused on measuring Oncology service, Nursing staff, Psychosocial intervention, Coping skills
Eligibility Criteria
Inclusion Criteria:
- Must have RN degree
- Must be employed as an oncology nurse in an inpatient, infusion, or ambulatory care unit
Exclusion Criteria:
- Participation in earlier pilot trial of the intervention
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Psychological education program
Waitlist
Arm Description
Patients receive the psychological education program upon study enrollment.
Participants are assigned to a 16-week wait-list period upon enrollment. Participants are invited to receive the psychological education program following the waitlist period.
Outcomes
Primary Outcome Measures
Change from baseline in psychological stress as measured by the Perceived Stress Scale and the Maslach Burnout Inventory
Secondary Outcome Measures
Change in from baseline in medical errors as measured by the Medical Errors Questionnaire
Full Information
NCT ID
NCT01593683
First Posted
May 4, 2012
Last Updated
July 9, 2013
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01593683
Brief Title
Waitlist-controlled Trial of a Psychological Education Program for Nurses
Official Title
Waitlist-controlled Trial of a Psychological Education Program for Nurses
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Unknown status
Study Start Date
March 2012 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
September 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to test a brief education program for oncology nurses, to enhance their skills for managing psychosocial stressors associated with providing direct patient care. The investigators will explore efficacy of the intervention for reducing psychological stress and medical errors.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychological Stress
Keywords
Oncology service, Nursing staff, Psychosocial intervention, Coping skills
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Psychological education program
Arm Type
Experimental
Arm Description
Patients receive the psychological education program upon study enrollment.
Arm Title
Waitlist
Arm Type
No Intervention
Arm Description
Participants are assigned to a 16-week wait-list period upon enrollment. Participants are invited to receive the psychological education program following the waitlist period.
Intervention Type
Behavioral
Intervention Name(s)
Psychological education program for nurses
Intervention Description
Approximately 4 weekly one-hour group sessions led by study clinicians and 1 optional individual session with a single study clinician.
Primary Outcome Measure Information:
Title
Change from baseline in psychological stress as measured by the Perceived Stress Scale and the Maslach Burnout Inventory
Time Frame
At approximately 16 and 32 weeks post-baseline
Secondary Outcome Measure Information:
Title
Change in from baseline in medical errors as measured by the Medical Errors Questionnaire
Time Frame
At approximately 16 and 32 weeks post-baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Must have RN degree
Must be employed as an oncology nurse in an inpatient, infusion, or ambulatory care unit
Exclusion Criteria:
Participation in earlier pilot trial of the intervention
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William F Pirl, MD, MPH
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Waitlist-controlled Trial of a Psychological Education Program for Nurses
We'll reach out to this number within 24 hrs