Study of the Emotional Needs of Caregivers of Stem Cell Transplantation Patients

Sponsor
Fred Hutchinson Cancer Center (Other)
Overall Status
Completed
CT.gov ID
NCT00082654
Collaborator
National Cancer Institute (NCI) (NIH)
1
31

Study Details

Study Description

Brief Summary

RATIONALE: Understanding the emotional needs of spouses or others who are living with and caring for patients who have undergone stem cell transplantation may help improve the quality of life of both the caregivers and the patients.

PURPOSE: This clinical trial is studying the emotional needs of caregivers of patients who have undergone stem cell transplant.

Detailed Description

OBJECTIVES:
  • Assess expression of emotion, as a function of patient presence, among spousal or other cohabiting caregivers (CG) of post-hematopoietic stem cell transplantation patients.

  • Assess desynchrony among subjective (self-report) and expressive indicators of emotion, as a function of patient presence, in these participants.

  • Correlate CG dispositional inhibition and desynchrony with physical and marital satisfaction in these participants.

OUTLINE: Caregivers (CG) complete written questionnaires assessing demographics, positive and negative affect, dispositional inhibition, marital satisfaction, and physical health over 45 minutes to 1 hour on day 1. CG then engage in two oral emotional expression exercises (on the topic of caregiving and the transplant) over 2 hours on day 2. Patients are present for one oral emotional expression exercise.

Participants are followed at 2 weeks and 6 months.

PROJECTED ACCRUAL: A total of 60 patient/spouse couples will be accrued for this study within 18 months.

Study Design

Study Type:
Interventional
Official Title:
Emotional Needs of Caregivers and Patient/Spouse Couples During Hematopoietic Stem Cell Transplantation (HSCT)
Study Start Date :
Mar 1, 2002
Actual Primary Completion Date :
Oct 1, 2004
Actual Study Completion Date :
Oct 1, 2004

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    DISEASE CHARACTERISTICS:
    • In a marriage OR long-term, committed, heterosexual or homosexual, cohabiting relationship in which one member is post-hematopoietic stem cell transplantation

    • Patients must meet the following criteria:

    • At least 1 year since prior first bone marrow, stem cell, or umbilical cord blood transplantation

    • Allogeneic or autologous

    • Diagnosis of malignancy, myelodysplasia, or non-malignancy

    • No indication of possible or confirmed relapse

    • Spouse/caregiver (CG) must meet the following criteria:

    • Serve as the primary CG to the patient

    • No prior or concurrent neurologic disorder

    PATIENT CHARACTERISTICS:

    Age

    • 21 and over

    Performance status

    • Not specified

    Life expectancy

    • Not specified

    Hematopoietic

    • Not specified

    Hepatic

    • Not specified

    Renal

    • Not specified

    Other

    • No concurrent major psychiatric disorder

    • English-speaking

    PRIOR CONCURRENT THERAPY:

    Biologic therapy

    • See Disease Characteristics

    Chemotherapy

    • Not specified

    Endocrine therapy

    • Not specified

    Radiotherapy

    • Not specified

    Surgery

    • Not specified

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fred Hutchinson Cancer Research Center Seattle Washington United States 98109-1024

    Sponsors and Collaborators

    • Fred Hutchinson Cancer Center
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Shelby Langer, PhD, Fred Hutchinson Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00082654
    Other Study ID Numbers:
    • 1639.00
    • CDR0000355106
    First Posted:
    May 19, 2004
    Last Update Posted:
    Sep 21, 2010
    Last Verified:
    Sep 1, 2010
    Keywords provided by , ,
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 21, 2010