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Spouses/Partners Expressing Their Thoughts After Transplant

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01061801
First Posted: February 3, 2010
Last Update Posted: February 8, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Washington
Information provided by:
Fred Hutchinson Cancer Research Center
  Purpose
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.

Condition Intervention
Cancer Hematopoietic Stem Cell Transplantation Behavioral: Emotional expression

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Emotional Expression and Cancer Caregivers

Resource links provided by NLM:


Further study details as provided by Fred Hutchinson Cancer Research Center:

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

Enrollment: 122
Study Start Date: August 2006
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: Emotional disclosure

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01061801


Locations
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
University of Washington
Investigators
Principal Investigator: Shelby Langer, PhD FHCRC/UW Cancer Consortium
  More Information

Publications:
Responsible Party: Shelby Langer (Principal Investigator), Fred Hutchinson Cancer Research Center and the University of Washington
ClinicalTrials.gov Identifier: NCT01061801     History of Changes
Other Study ID Numbers: 2076.00
First Submitted: February 2, 2010
First Posted: February 3, 2010
Last Update Posted: February 8, 2010
Last Verified: February 2010

Keywords provided by Fred Hutchinson Cancer Research Center:
caregivers
cancer
emotion
protective buffering