Spouses/Partners Expressing Their Thoughts After Transplant

February 4, 2010 updated by: Fred Hutchinson Cancer Center

Emotional Expression and Cancer Caregivers

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

122

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
        • 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

Yes

Genders Eligible for Study

All

Description

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

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?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Emotional expression, patient present
Caregivers are asked to talk about their deepest thoughts and feelings regarding the patient's transplant and their role as caregiver, in the presence of the patient (one session).
Behavioral: Emotional expression
Caregivers are given the opportunity to express their thoughts and feelings regarding the patient's transplant and their role as caregiver
Other Names:
  • Emotional disclosure
Experimental: Emotional expression, patient absent
Caregivers are asked to talk about their deepest thoughts and feelings regarding the patient's transplant and their role as caregiver, in the absence of the patient (3 sessions).
Behavioral: Emotional expression
Caregivers are given the opportunity to express their thoughts and feelings regarding the patient's transplant and their role as caregiver
Other Names:
  • Emotional disclosure
Active Comparator: Comparison
Caregivers are asked to talk about their plans for the upcoming week (time management, sessions 1 and 3) and positive aspects of their life (session 2).
Behavioral: Emotional expression
Caregivers are given the opportunity to express their thoughts and feelings regarding the patient's transplant and their role as caregiver
Other Names:
  • Emotional disclosure

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Fred Hutchinson Cancer Center

Collaborators

University of Washington

Investigators

  • Principal Investigator: Shelby Langer, PhD, FHCRC/UW Cancer Consortium

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

August 1, 2006

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

February 2, 2010

First Submitted That Met QC Criteria

February 2, 2010

First Posted (Estimate)

February 3, 2010

Study Record Updates

Last Update Posted (Estimate)

February 8, 2010

Last Update Submitted That Met QC Criteria

February 4, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2076.00

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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