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: July 9, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Psychological Stress
Behavioral: Psychological education program for nurses

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Waitlist-controlled Trial of a Psychological Education Program for Nurses

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 42
Study Start Date: March 2012
Estimated Study Completion Date: September 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01593683

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: William F Pirl, MD, MPH Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: William Pirl, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01593683     History of Changes
Other Study ID Numbers: MGH 2011-P-002799
Study First Received: May 4, 2012
Last Updated: July 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Oncology service
Nursing staff
Psychosocial intervention
Coping skills

Additional relevant MeSH terms:
Stress, Psychological
Behavioral Symptoms

ClinicalTrials.gov processed this record on October 23, 2014