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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00082654
Recruitment Status : Completed
First Posted : May 19, 2004
Last Update Posted : September 21, 2010
Information provided by:

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.

Condition or disease Intervention/treatment
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

Detailed Description:


  • 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  (Clinical Trial)
Official Title: Emotional Needs of Caregivers and Patient/Spouse Couples During Hematopoietic Stem Cell Transplantation (HSCT)
Study Start Date : March 2002
Primary Completion Date : October 2004
Study Completion Date : October 2004

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 21 and over

Performance status

  • Not specified

Life expectancy

  • Not specified


  • Not specified


  • Not specified


  • Not specified


  • No concurrent major psychiatric disorder
  • English-speaking


Biologic therapy

  • See Disease Characteristics


  • Not specified

Endocrine therapy

  • Not specified


  • Not specified


  • Not specified
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00082654

United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Principal Investigator: Shelby Langer, PhD Fred Hutchinson Cancer Research Center
More Information

ClinicalTrials.gov Identifier: NCT00082654     History of Changes
Other Study ID Numbers: 1639.00
First Posted: May 19, 2004    Key Record Dates
Last Update Posted: September 21, 2010
Last Verified: September 2010

Keywords provided by Fred Hutchinson Cancer Research Center:
psychosocial effects of cancer and its treatment
accelerated phase chronic myelogenous leukemia
adult acute lymphoblastic leukemia in remission
adult acute myeloid leukemia in remission
atypical chronic myeloid leukemia
blastic phase chronic myelogenous leukemia
chronic eosinophilic leukemia
chronic idiopathic myelofibrosis
chronic myelomonocytic leukemia
chronic neutrophilic leukemia
chronic phase chronic myelogenous leukemia
de novo myelodysplastic syndromes
disseminated neuroblastoma
myelodysplastic/myeloproliferative disease, unclassifiable
noncontiguous stage II adult Burkitt lymphoma
noncontiguous stage II adult diffuse large cell lymphoma
noncontiguous stage II adult diffuse mixed cell lymphoma
noncontiguous stage II adult diffuse small cleaved cell lymphoma
noncontiguous stage II adult immunoblastic large cell lymphoma
noncontiguous stage II adult lymphoblastic lymphoma
noncontiguous stage II grade 1 follicular lymphoma
noncontiguous stage II grade 2 follicular lymphoma
noncontiguous stage II grade 3 follicular lymphoma
noncontiguous stage II mantle cell lymphoma
poor prognosis metastatic gestational trophoblastic tumor
previously treated myelodysplastic syndromes
recurrent adult acute lymphoblastic leukemia
recurrent adult acute myeloid leukemia
recurrent adult Burkitt lymphoma
recurrent adult diffuse large cell lymphoma

Additional relevant MeSH terms:
Breast Neoplasms
Multiple Myeloma
Neoplasms, Plasma Cell
Myelodysplastic Syndromes
Neoplasms, Germ Cell and Embryonal
Testicular Neoplasms
Myeloproliferative Disorders
Myelodysplastic-Myeloproliferative Diseases
Trophoblastic Neoplasms
Gestational Trophoblastic Disease
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Pathologic Processes
Neoplasms by Site
Breast Diseases
Skin Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases