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Study of the Emotional Needs of Caregivers of Stem Cell Transplantation Patients
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00082654
  Purpose

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 Intervention
Breast Cancer
Cancer-Related Problem/Condition
Chronic Myeloproliferative Disorders
Gestational Trophoblastic Tumor
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Diseases
Neuroblastoma
Ovarian Cancer
Testicular Germ Cell Tumor
Procedure: psychosocial assessment and care

Genetics Home Reference related topics: aceruloplasminemia breast cancer hemophilia
MedlinePlus related topics: Breast Cancer Cancer Caregivers Leukemia, Adult Acute Leukemia, Adult Chronic Lymphoma Multiple Myeloma Neuroblastoma Ovarian Cancer
U.S. FDA Resources
Study Type: Interventional
Official Title: Emotional Needs of Caregivers and Patient/Spouse Couples During Hematopoietic Stem Cell Transplantation (HSCT)

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: March 2002
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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00082654

Locations
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Investigators
Principal Investigator: Shelby Langer, PhD Fred Hutchinson Cancer Research Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000355106, FHCRC-1639.00
Study First Received: May 14, 2004
Last Updated: November 16, 2008
ClinicalTrials.gov Identifier: NCT00082654  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
psychosocial effects/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

Study placed in the following topic categories:
Blast Crisis
Sezary syndrome
Chronic myelogenous leukemia
Hodgkin lymphoma, adult
Lymphoma, small cleaved-cell, diffuse
Urogenital Neoplasms
Lymphoma, large-cell, immunoblastic
Preleukemia
Hemorrhagic Disorders
Neoplasm Metastasis
Neuroepithelioma
Endocrine Gland Neoplasms
Myelodysplastic syndromes
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Hematologic Diseases
Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative
Leukemia, Myelomonocytic, Chronic
Blood Coagulation Disorders
Genital Neoplasms, Female
Acute myelogenous leukemia
Breast Neoplasms
Testicular Neoplasms
Leukemia, Myeloid
Myelodysplastic myeloproliferative disease
Leukemia, Myeloid, Accelerated Phase
B-cell lymphomas
Lymphoma, Non-Hodgkin
Hairy cell leukemia
Neoplasms, Glandular and Epithelial
Precancerous Conditions

Additional relevant MeSH terms:
Neoplasms
Pregnancy Complications, Neoplastic
Pathologic Processes
Disease
Neoplasms by Histologic Type
Neoplasms by Site
Immune System Diseases
Syndrome
Neoplasms, Nerve Tissue
Cardiovascular Diseases
Neoplasms, Neuroepithelial
Adnexal Diseases

ClinicalTrials.gov processed this record on January 15, 2009