Spouses/Partners Expressing Their Thoughts After Transplant

Cancer Clinical Trial

Official title:

Emotional Expression and Cancer Caregivers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01061801
• Other study ID #: 2076.00
• Status: Completed
• Phase: N/A
• First received: February 2, 2010
• Last updated: February 4, 2010
• Start date: August 2006
• Est. completion date: July 2009

Study information

• Verified date: February 2010
• Source: Fred Hutchinson Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years and older

Eligibility

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 Design

Allocation: Randomized, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cancer
• Hematopoietic Stem Cell Transplantation

Intervention

Behavioral:
• Emotional expression
Caregivers are given the opportunity to express their thoughts and feelings regarding the patient's transplant and their role as caregiver

Locations

Country	Name	City	State
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Research Center	University of Washington

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-reported mental and physical health as measured by the Short Form-36 Health Survey		baseline, 1-month follow-up, and 4-month follow-up	No
Primary	Marital satisfaction as measured by the Dyadic Adjustment Scale		pre-transplant, baseline, 1-month follow-up, and 4-month follow-up	No
Primary	Self- and partner-reported protective buffering as measured by the Protective Buffering Scale		pre-transplant, baseline, 1-month follow-up, and 4-month follow-up	No
Secondary	Emotional experience as assessed by the Positive and Negative Affect Schedule		During intervention/ disclosure sessions	No
Secondary	Galvanic skin response (physiological indicator of emotion)		During intervention/ disclosure sessions	No
Secondary	Emotional expression (facial expression and words uttered)		During intervention/ disclosure sessions	No