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

September 17, 2010 updated by: Fred Hutchinson Cancer Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98109-1024
        • Fred Hutchinson Cancer Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fred Hutchinson Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Shelby Langer, PhD, Fred Hutchinson Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2002

Primary Completion (Actual)

October 1, 2004

Study Completion (Actual)

October 1, 2004

Study Registration Dates

First Submitted

May 14, 2004

First Submitted That Met QC Criteria

May 18, 2004

First Posted (Estimate)

May 19, 2004

Study Record Updates

Last Update Posted (Estimate)

September 21, 2010

Last Update Submitted That Met QC Criteria

September 17, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1639.00
  • CDR0000355106

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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