Spouses/Partners Expressing Their Thoughts After Transplant

NCT ID: NCT01061801

Last Updated: 2010-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2009-07-31

Brief Summary

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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

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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.

Conditions

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Cancer Hematopoietic Stem Cell Transplantation

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Emotional expression

Intervention Type BEHAVIORAL

Caregivers are given the opportunity to express their thoughts and feelings regarding the patient's transplant and their role as caregiver

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).

Group Type EXPERIMENTAL

Emotional expression

Intervention Type BEHAVIORAL

Caregivers are given the opportunity to express their thoughts and feelings regarding the patient's transplant and their role as caregiver

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).

Group Type ACTIVE_COMPARATOR

Emotional expression

Intervention Type BEHAVIORAL

Caregivers are given the opportunity to express their thoughts and feelings regarding the patient's transplant and their role as caregiver

Interventions

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Emotional expression

Caregivers are given the opportunity to express their thoughts and feelings regarding the patient's transplant and their role as caregiver

Intervention Type BEHAVIORAL

Other Intervention Names

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Emotional disclosure

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Washington

OTHER

Sponsor Role collaborator

Fred Hutchinson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Fred Hutchinson Cancer Research Center and the University of Washington

Principal Investigators

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Shelby Langer, PhD

Role: PRINCIPAL_INVESTIGATOR

FHCRC/UW Cancer Consortium

Locations

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Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 19731352 (View on PubMed)

Other Identifiers

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2076.00

Identifier Type: -

Identifier Source: org_study_id

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