NCT01341873

Brief Summary

This randomized clinical trial studies nursing intervention in supporting family caregivers (FCs) of patients undergoing stem cell transplant. A nursing intervention may help prepare FCs support the recovery of the patients

Trial Health

10
At Risk

Trial Health Score

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

Status
withdrawn

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Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 26, 2011

Completed
1 year until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Last Updated

April 23, 2012

Status Verified

April 1, 2012

Enrollment Period

4.4 years

First QC Date

April 21, 2011

Last Update Submit

April 20, 2012

Conditions

Anxiety DisorderDepressionFatigue

Outcome Measures

Primary Outcomes (5)

  • Test the effects of an advanced practice nursing (APN) intervention for family caregivers (FCs) in the experimental group using questionnaires measuring quality of life and psychological distress as compared to the FCs in the control group.

    12 months after discharge

  • Test the effects of an advanced practice nursing (APN) intervention for family caregivers (FCs) in the experimental group using questionnaires measuring caregiver burden and skills preparedness as compared to the FCs in the control group.

    12 months after discharge

  • Through the use of questionnaires, comparison of self-care behaviors for FCs of Hematopoietic Cell Transplant (HCT) patients between the experimental and control groups

    12 months after discharge

  • Through the use of questionnaires, comparison of resource use between the experimental and control groups

    12 months after discharge

  • Through the use of questionnaires, identification of subgroups of FCs who benefit most from the Family Care Intervention (FCI) in relation to sociodemographic characteristics, caregiver health status, and patient characteristics

    12 months after discharge

Secondary Outcomes (1)

  • Through the use of questionnaires, measure FCs satisfaction with the FCI

    12 months after discharge

Study Arms (2)

Group I (FCI)

EXPERIMENTAL

FCs receive 4 sessions of an APN FCI beginning during the admission for transplant and continuing for up to 100 days after transplant.

Other: educational interventionOther: psychosocial support for caregiverProcedure: quality-of-life assessmentOther: questionnaire administration

Group II (control)

OTHER

FCs receive standard supportive care.

Procedure: quality-of-life assessmentOther: questionnaire administration

Interventions

educational interventionOTHER

Undergo APN FCI

Also known as: intervention, educational
Group I (FCI)
psychosocial support for caregiverOTHER

Undergo APN FCI

Group I (FCI)
quality-of-life assessmentPROCEDURE

Ancillary studies

Also known as: quality of life assessment
Group I (FCI)Group II (control)
questionnaire administrationOTHER

Ancillary studies

Group I (FCI)Group II (control)

Eligibility Criteria

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

You may qualify if:

  • The primary family caregiver as identified by a hematologic cancer patient who is scheduled for a single allogeneic bone marrow or stem cell transplant; the definition of a family caregiver for the purposes of this proposal refers to either a family member or friend that is identified by the patient as being the primary caregiver
  • Living within a 50 mile radius of City of Hope

You may not qualify if:

  • Caregivers who are unable to read English or Spanish consent forms
  • Caregivers who live more than 50 miles from City of Hope

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Anxiety DisordersDepressionFatigue

Interventions

Early Intervention, EducationalMethodsPsychiatric RehabilitationCaregivers

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehaviorSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health ServicesInvestigative TechniquesRehabilitationTherapeuticsHealth Personnel

Study Officials

  • Marcia Grant, RN, DNSC

    City of Hope Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2011

First Posted

April 26, 2011

Study Start

May 1, 2012

Primary Completion

October 1, 2016

Last Updated

April 23, 2012

Record last verified: 2012-04