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

Primary Purpose

Anxiety Disorder, Depression, Fatigue

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
educational intervention
psychosocial support for caregiver
quality-of-life assessment
questionnaire administration
Sponsored by
City of Hope Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anxiety Disorder

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    Group I (FCI)

    Group II (control)

    Arm Description

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

    FCs receive standard supportive care.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    April 21, 2011
    Last Updated
    April 20, 2012
    Sponsor
    City of Hope Medical Center
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01341873
    Brief Title
    Nursing Intervention in Supporting Family Caregivers of Patients Undergoing Stem Cell Transplant
    Official Title
    Nursing Intervention for Family Caregivers of HCT Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2012
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    The protocol was not funded by the NCI
    Study Start Date
    May 2012 (undefined)
    Primary Completion Date
    October 2016 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    City of Hope Medical Center
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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
    Detailed 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anxiety Disorder, Depression, Fatigue

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Single
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group I (FCI)
    Arm Type
    Experimental
    Arm Description
    FCs receive 4 sessions of an APN FCI beginning during the admission for transplant and continuing for up to 100 days after transplant.
    Arm Title
    Group II (control)
    Arm Type
    Other
    Arm Description
    FCs receive standard supportive care.
    Intervention Type
    Other
    Intervention Name(s)
    educational intervention
    Other Intervention Name(s)
    intervention, educational
    Intervention Description
    Undergo APN FCI
    Intervention Type
    Other
    Intervention Name(s)
    psychosocial support for caregiver
    Intervention Description
    Undergo APN FCI
    Intervention Type
    Procedure
    Intervention Name(s)
    quality-of-life assessment
    Other Intervention Name(s)
    quality of life assessment
    Intervention Description
    Ancillary studies
    Intervention Type
    Other
    Intervention Name(s)
    questionnaire administration
    Intervention Description
    Ancillary studies
    Primary Outcome Measure Information:
    Title
    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.
    Time Frame
    12 months after discharge
    Title
    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.
    Time Frame
    12 months after discharge
    Title
    Through the use of questionnaires, comparison of self-care behaviors for FCs of Hematopoietic Cell Transplant (HCT) patients between the experimental and control groups
    Time Frame
    12 months after discharge
    Title
    Through the use of questionnaires, comparison of resource use between the experimental and control groups
    Time Frame
    12 months after discharge
    Title
    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
    Time Frame
    12 months after discharge
    Secondary Outcome Measure Information:
    Title
    Through the use of questionnaires, measure FCs satisfaction with the FCI
    Time Frame
    12 months after discharge

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Marcia Grant, RN, DNSC
    Organizational Affiliation
    City of Hope Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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