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Completed

NCT Number: NCT01061801

Spouses/Partners Expressing Their Thoughts After Transplant

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.

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Key information

Conditions

Cancer Hematopoietic Stem Cell Transplantation Neoplasms

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Emotional expression

Behavioral

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

Primary outcomes

  1. 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

  2. Marital satisfaction as measured by the Dyadic Adjustment Scale

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

  3. 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

  1. Emotional experience as assessed by the Positive and Negative Affect Schedule

    Time frame: During intervention/ disclosure sessions

  2. Galvanic skin response (physiological indicator of emotion)

    Time frame: During intervention/ disclosure sessions

  3. Emotional expression (facial expression and words uttered)

    Time frame: During intervention/ disclosure sessions

Sponsors and collaborators

Lead sponsor

Fred Hutchinson Cancer Center

Other

Collaborators

  • University of Washington

Registry information

Official study title

Emotional Expression and Cancer Caregivers

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Feb 3, 2010
Registry last updated
Feb 8, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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