NCT00827437

Brief Summary

The primary aim of this single site study was to assess the feasibility of implementing a staff/parent communication intervention within 72 hours of the parents making an end-of-life decision on behalf of their child.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
401

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 6, 2008

Completed
6 months until next milestone

First Posted

Study publicly available on registry

January 22, 2009

Completed
Last Updated

April 23, 2012

Status Verified

June 1, 2011

Enrollment Period

3.8 years

First QC Date

August 6, 2008

Last Update Submit

April 20, 2012

Conditions

Outcome Measures

Primary Outcomes (1)

  • To assess the feasibility of delivering the two-part communication intervention. The definition of feasible is that 50% of all interventions are successfully implemented.

    22 months

Study Arms (1)

1

OTHER
Other: Parent Interview

Interventions

To include the PI, Nursing Research Specialist,Clinical Research Associate or Clinical Nurse Specialist

1

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Eligible parents/guardian can be enrolled only one time and will be:
  • years of age and older.
  • This study will enroll only parents/guardians who are 21 years of age and older. The investigators clinical experience is that when the parent/guardian is younger, additional adult members of the family are involved in the decision making and that asking a single person to identify him or herself as the primary parent/guardian creates difficulties for the family.
  • As a result, no parent/guardian younger than age 21 will be enrolled in this study.
  • English-speaking.
  • Willing to give written consent to participate.
  • The parents/guardians of a child with incurable cancer or a fatal cancer-related condition who is being treated at St. Jude Children's Research Hospital
  • The parents/guardians who made an end-of-life decision on behalf of the seriously ill child within the previous 72-hours.
  • Eligible staff can be enrolled more than one time and will be:
  • English-speaking
  • Willing to give written consent to participate

You may not qualify if:

  • Parents/guardians who meet the above criteria but are identified by their attending or social support staff member (an assigned social worker or psychologist at St. Jude Children's Research Hospital) as emotionally or mentally unable to participate in the informed consent process will not be approached about participating in the study.
  • Parents who are identified by their attending or social support staff member as likely to find the study too burdensome because of their emotional or mental state.
  • Parents who did not make the end-of-life decision (i.e., when the patient made the decision).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

Study Officials

  • Pamela S Hinds, PhD, RN

    St. Jude Children's Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 6, 2008

First Posted

January 22, 2009

Study Start

January 1, 2004

Primary Completion

November 1, 2007

Last Updated

April 23, 2012

Record last verified: 2011-06

Locations