Waitlist-controlled Trial of a Psychological Education Program for Nurses

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

William Pirl, Massachusetts General Hospital

ClinicalTrials.gov Identifier:

NCT01593683

First received: May 4, 2012

Last updated: May 7, 2012

Last verified: May 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

May 4, 2012

Last Updated Date

May 7, 2012

Start Date ^ICMJE

March 2012

Estimated Primary Completion Date

January 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01593683 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change in from baseline in medical errors as measured by the Medical Errors Questionnaire [ Time Frame: At approximately 16 and 32 weeks post-baseline ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Waitlist-controlled Trial of a Psychological Education Program for Nurses

Official Title ^ICMJE

Waitlist-controlled Trial of a Psychological Education Program for Nurses

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care

Condition ^ICMJE

Psychological Stress

Intervention ^ICMJE

Behavioral: Psychological education program for nurses

Approximately 4 weekly one-hour group sessions led by study clinicians and 1 optional individual session with a single study clinician.

Study Arm (s)

Experimental: Psychological education program
Patients receive the psychological education program upon study enrollment.

Intervention: Behavioral: Psychological education program for nurses
No Intervention: Waitlist
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.

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

March 2013

Estimated Primary Completion Date

January 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01593683

Other Study ID Numbers ^ICMJE

MGH 2011-P-002799

Has Data Monitoring Committee

Responsible Party

William Pirl, Massachusetts General Hospital

Study Sponsor ^ICMJE

Massachusetts General Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

William F Pirl, MD, MPH

Massachusetts General Hospital

Information Provided By

Massachusetts General Hospital

Verification Date

May 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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