Nursing Intervention in Supporting Family Caregivers of Patients Undergoing Stem Cell Transplant

NCT ID: NCT01341873

Last Updated: 2012-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Brief Summary

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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

Detailed Description

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PRIMARY OBJECTIVES:

I. Test the effects of an advanced practice nursing (APN) intervention for family caregivers (FCs) of hematopoietic cell transplant (HCT) patients in the experimental group on FC quality of life, psychological distress, caregiver burden, caregiver skills preparedness as compared to FCs in the control group.

II. Describe self-care behaviors for FCs of HCT patients and compare them between the experimental and control groups.

III. Describe resource use by FCs comparing the experimental and control groups.

IV. Identify subgroups of FCs who benefit most from the family caregiver intervention (FCI) in relation to sociodemographic characteristics, caregiver health status, and patient characteristics.

SECONDARY OBJECTIVES:

I. Describe family caregivers' satisfaction with the FCI.

OUTLINE: FCs are randomized to 1 of 2 groups.

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

GROUP II: FCs receive standard supportive care.

After completion of study, FCs are followed up at 3, 6, and 12 months.

Conditions

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Anxiety Disorder Depression Fatigue

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Study Groups

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Group I (FCI)

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

Group Type EXPERIMENTAL

educational intervention

Intervention Type OTHER

Undergo APN FCI

psychosocial support for caregiver

Intervention Type OTHER

Undergo APN FCI

quality-of-life assessment

Intervention Type PROCEDURE

Ancillary studies

questionnaire administration

Intervention Type OTHER

Ancillary studies

Group II (control)

FCs receive standard supportive care.

Group Type OTHER

quality-of-life assessment

Intervention Type PROCEDURE

Ancillary studies

questionnaire administration

Intervention Type OTHER

Ancillary studies

Interventions

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educational intervention

Undergo APN FCI

Intervention Type OTHER

psychosocial support for caregiver

Undergo APN FCI

Intervention Type OTHER

quality-of-life assessment

Ancillary studies

Intervention Type PROCEDURE

questionnaire administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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intervention, educational quality of life assessment

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

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

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

City of Hope Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marcia Grant, RN, DNSC

Role: PRINCIPAL_INVESTIGATOR

City of Hope Medical Center

Other Identifiers

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NCI-2011-00574

Identifier Type: REGISTRY

Identifier Source: secondary_id

10235

Identifier Type: -

Identifier Source: org_study_id

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