Clinical trial NCT01061801: Spouses/Partners Expressing Their Thoughts After Transplant
Official title: Emotional Expression and Cancer Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Hematopoietic Stem Cell Transplantation
Keywords: caregivers
cancer
emotion
protective buffering
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: University of Washington
First posted: 2010-02-03
Enrollment: 122
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Self-reported mental and physical health as measured by the Short Form-36 Health Survey
timeFrame: baseline, 1-month follow-up, and 4-month follow-up
measure: Marital satisfaction as measured by the Dyadic Adjustment Scale
timeFrame: pre-transplant, baseline, 1-month follow-up, and 4-month follow-up
measure: Self- and partner-reported protective buffering as measured by the Protective Buffering Scale
timeFrame: pre-transplant, baseline, 1-month follow-up, and 4-month follow-up
Secondary outcomes:
measure: Emotional experience as assessed by the Positive and Negative Affect Schedule
timeFrame: During intervention/ disclosure sessions
measure: Galvanic skin response (physiological indicator of emotion)
timeFrame: During intervention/ disclosure sessions
measure: Emotional expression (facial expression and words uttered)
timeFrame: During intervention/ disclosure sessions
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
Study officials:
affiliation: FHCRC/UW Cancer Consortium
name: Shelby Langer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Langer SL, Brown JD, Syrjala KL. Intrapersonal and interpersonal consequences of protective buffering among cancer patients and caregivers. Cancer. 2009 Sep 15;115(18 Suppl):4311-25. doi: 10.1002/cncr.24586.