Spouses/Partners Expressing Their Thoughts After Transplant

Not Applicable

Completed

• Conditions: Cancer; Hematopoietic Stem Cell Transplantation
• Interventions: Behavioral: Emotional expression

• Registration Number: NCT01061801
• Lead Sponsor: Fred Hutchinson Cancer Center

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.

Study Timeline

• Study Start: 2006-08
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Status Verified: 2010-02
• Study First Submitted: 2010-02-02
• Study First Submitted QC: 2010-02-02
• Study First Posted: 2010-02-03
• Last Update Submitted: 2010-02-04
• Last Update Posted: 2010-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

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

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Emotional expression, patient present	Emotional expression	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).
Emotional expression, patient absent	Emotional expression	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).
Comparison	Emotional expression	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).

Primary Outcome Measures

Name	Time	Method
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
Marital satisfaction as measured by the Dyadic Adjustment Scale	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	pre-transplant, baseline, 1-month follow-up, and 4-month follow-up

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Fred Hutchinson Cancer Research Center; 🇺🇸 Seattle, Washington, United States