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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT00082654
First received: May 14, 2004
Last updated: September 17, 2010
Last verified: September 2010

May 14, 2004
September 17, 2010
March 2002
October 2004   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00082654 on ClinicalTrials.gov Archive Site
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Study of the Emotional Needs of Caregivers of Stem Cell Transplantation Patients
Emotional Needs of Caregivers and Patient/Spouse Couples During Hematopoietic Stem Cell Transplantation (HSCT)

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.

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.

Interventional
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  • Breast Cancer
  • Chronic Myeloproliferative Disorders
  • Gestational Trophoblastic Tumor
  • Leukemia
  • Lymphoma
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Myelodysplastic Syndromes
  • Myelodysplastic/Myeloproliferative Diseases
  • Neuroblastoma
  • Ovarian Cancer
  • Psychosocial Effects of Cancer and Its Treatment
  • Testicular Germ Cell Tumor
Procedure: psychosocial assessment and care
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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October 2004
October 2004   (final data collection date for primary outcome measure)

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
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00082654
1639.00, CDR0000355106
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Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Principal Investigator: Shelby Langer, PhD Fred Hutchinson Cancer Research Center
Fred Hutchinson Cancer Research Center
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP