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Clinical Trials/NCT01061801
NCT01061801
Completed
Not Applicable

Emotional Expression and Cancer Caregivers

Fred Hutchinson Cancer Center1 site in 1 country122 target enrollmentAugust 2006

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cancer
Sponsor
Fred Hutchinson Cancer Center
Enrollment
122
Locations
1
Primary Endpoint
Self-reported mental and physical health as measured by the Short Form-36 Health Survey
Status
Completed
Last Updated
16 years ago

Overview

Brief Summary

This study seeks to test a brief psychological intervention for spousal caregivers of cancer patients (specifically, hematopoietic stem cell transplant patients), persons known to experience emotional distress.

Detailed Description

This project focuses on spousal caregivers (CGs) of hematopoietic stem cell transplant survivors - persons known to report elevated levels of distress as compared to both norms and their patient counterparts. Specific Aims are to: (1) Determine, via experimental manipulation, whether or not CGs of hematopoietic stem cell transplant patients engage in protective buffering, a coping mechanism whereby partners shield patients from illness-related concerns or worries, (2) Examine synchrony or lack thereof, desynchrony, among subjective, expressive and biologic indicators of emotion among spousal CGs, and (3) Test the feasibility and implementation of an emotional expression (EE) exercise designed to enhance psychological and immune functioning among spousal CGs.

Registry
clinicaltrials.gov
Start Date
August 2006
End Date
July 2009
Last Updated
16 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • patients and partners at least 21 years of age
  • patients and partners English speaking
  • patients about to receive a hematopoietic stem cell transplant
  • patients married or in a committed, cohabiting, heterosexual or homosexual relationship
  • caregivers in a married or committed, cohabiting, heterosexual or homosexual relationship with the patient
  • caregivers present at the transplant site and planning to remain so for at least one month

Exclusion Criteria

  • patient major psychiatric disorder
  • caregiver presence or history of a neurologic disorder

Outcomes

Primary Outcomes

Self-reported mental and physical health as measured by the Short Form-36 Health Survey

Time Frame: baseline, 1-month follow-up, and 4-month follow-up

Marital satisfaction as measured by the Dyadic Adjustment Scale

Time Frame: pre-transplant, baseline, 1-month follow-up, and 4-month follow-up

Self- and partner-reported protective buffering as measured by the Protective Buffering Scale

Time Frame: pre-transplant, baseline, 1-month follow-up, and 4-month follow-up

Secondary Outcomes

  • Galvanic skin response (physiological indicator of emotion)(During intervention/ disclosure sessions)
  • Emotional experience as assessed by the Positive and Negative Affect Schedule(During intervention/ disclosure sessions)
  • Emotional expression (facial expression and words uttered)(During intervention/ disclosure sessions)

Study Sites (1)

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