NCT01061801

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P50-P75 for not_applicable cancer

Timeline
Completed

Started Aug 2006

Typical duration for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 3, 2010

Completed
Last Updated

February 8, 2010

Status Verified

February 1, 2010

Enrollment Period

2.9 years

First QC Date

February 2, 2010

Last Update Submit

February 4, 2010

Conditions

CancerHematopoietic Stem Cell Transplantation

Keywords

caregiverscanceremotionprotective buffering

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (3)

  • 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

Study Arms (3)

Emotional expression, patient present

EXPERIMENTAL

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).

Behavioral: Emotional expression

Emotional expression, patient absent

EXPERIMENTAL

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).

Behavioral: Emotional expression

Comparison

ACTIVE COMPARATOR

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).

Behavioral: Emotional expression

Interventions

Emotional expressionBEHAVIORAL

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

Also known as: Emotional disclosure
ComparisonEmotional expression, patient absentEmotional expression, patient present

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • patient major psychiatric disorder
  • caregiver presence or history of a neurologic disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

Related 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.

    PMID: 19731352RESULT

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Shelby Langer, PhD

    FHCRC/UW Cancer Consortium

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 2, 2010

First Posted

February 3, 2010

Study Start

August 1, 2006

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

February 8, 2010

Record last verified: 2010-02

Locations

US(1)