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

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
No phase specified Educational/Counseling/Training, Supportive care Completed 21 and over NCI, Other FHCRC-1639.00
CDR0000355106, NCT00082654

Trial Description

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.

Further Study Information

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 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Fred Hutchinson Cancer Research Center

National Cancer Institute

Shelby Langer

Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00082654
Information obtained from ClinicalTrials.gov on September 16, 2009

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.