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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01341873
Other study ID # 10235
Secondary ID NCI-2011-00574
Status Withdrawn
Phase N/A
First received April 21, 2011
Last updated April 20, 2012
Start date May 2012

Study information

Verified date April 2012
Source City of Hope Medical Center
Contact n/a
Is FDA regulated No
Health authority United States: Federal GovernmentUnited States: Institutional Review Board
Study type Interventional

Clinical Trial 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


Description:

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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date October 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 21 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Other:
educational intervention
Undergo APN FCI
psychosocial support for caregiver
Undergo APN FCI
Procedure:
quality-of-life assessment
Ancillary studies
Other:
questionnaire administration
Ancillary studies

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
City of Hope Medical Center National Cancer Institute (NCI)

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Primary 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 No
Primary 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 No
Primary Through the use of questionnaires, comparison of resource use between the experimental and control groups 12 months after discharge No
Primary 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 No
Secondary Through the use of questionnaires, measure FCs satisfaction with the FCI 12 months after discharge No
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