NCT01593683

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2012

Geographic Reach
1 country

1 active site

Status
unknown

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

March 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 8, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

July 10, 2013

Status Verified

July 1, 2013

Enrollment Period

10 months

First QC Date

May 4, 2012

Last Update Submit

July 9, 2013

Conditions

Psychological Stress

Keywords

Oncology serviceNursing staffPsychosocial interventionCoping skills

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in psychological stress as measured by the Perceived Stress Scale and the Maslach Burnout Inventory

    At approximately 16 and 32 weeks post-baseline

Secondary Outcomes (1)

  • Change in from baseline in medical errors as measured by the Medical Errors Questionnaire

    At approximately 16 and 32 weeks post-baseline

Study Arms (2)

Psychological education program

EXPERIMENTAL

Patients receive the psychological education program upon study enrollment.

Behavioral: Psychological education program for nurses

Waitlist

NO INTERVENTION

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.

Interventions

Psychological education program for nursesBEHAVIORAL

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

Psychological education program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must have RN degree
  • Must be employed as an oncology nurse in an inpatient, infusion, or ambulatory care unit

You may not qualify if:

  • Participation in earlier pilot trial of the intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Stress, PsychologicalNeoplasms

Interventions

Nurses

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Health PersonnelHealth Care Facilities Workforce and Services

Study Officials

  • William F Pirl, MD, MPH

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 4, 2012

First Posted

May 8, 2012

Study Start

March 1, 2012

Primary Completion

January 1, 2013

Study Completion

September 1, 2013

Last Updated

July 10, 2013

Record last verified: 2013-07

Locations

US(1)