Waitlist-controlled Trial of a Psychological Education Program for Nurses

July 9, 2013 updated by: William Pirl, Massachusetts General Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

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
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

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

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Psychological education program
Patients receive the psychological education program upon study enrollment.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
At approximately 16 and 32 weeks post-baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in from baseline in medical errors as measured by the Medical Errors Questionnaire
Time Frame: At approximately 16 and 32 weeks post-baseline
At approximately 16 and 32 weeks post-baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Investigators

  • Principal Investigator: William F Pirl, MD, MPH, Massachusetts General Hospital

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

March 1, 2012

Primary Completion (Actual)

January 1, 2013

Study Completion (Anticipated)

September 1, 2013

Study Registration Dates

First Submitted

May 4, 2012

First Submitted That Met QC Criteria

May 7, 2012

First Posted (Estimate)

May 8, 2012

Study Record Updates

Last Update Posted (Estimate)

July 10, 2013

Last Update Submitted That Met QC Criteria

July 9, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MGH 2011-P-002799

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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