Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs No phase specified Educational/Counseling/Training Closed 21 and over NCI FHCRC-1639.00 NCT00082654

Objectives

1. Assess expression of emotion, as a function of patient presence, among spousal or other cohabiting caregivers (CG) of post-hematopoietic stem cell transplantation patients.
2. Assess desynchrony among subjective (self-report) and expressive indicators of emotion, as a function of patient presence, in these participants.
3. Correlate CG dispositional inhibition and desynchrony with physical and marital satisfaction in these participants.

Entry 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

Prior/Concurrent Therapy:

Biologic therapy

• See Disease Characteristics

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

Fred Hutchinson Cancer Research Center

Shelby Langer, PhD, Principal investigator		Ph: 206-667-5162

Registry Information
Official Title		Emotional Needs of Caregivers and Patient/Spouse Couples During Hematopoietic Stem Cell Transplantation (HSCT)
Trial Start Date		2002-03-05
Registered in ClinicalTrials.gov		NCT00082654
Date Submitted to PDQ		2004-01-28
Information Last Verified		2006-09-08
NCI Grant/Contract Number		P30-CA15704, R03-CA96468

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