Expressive Writing in Improving Quality of Life in Patients With Breast Cancer and Lymphedema

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

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2011-01-31

Brief Summary

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RATIONALE: Expressive writing may help relieve symptoms and improve quality of life in breast cancer survivors with chronic lymphedema.

PURPOSE: This clinical trial is studying expressive writing in improving the quality of life in women with breast cancer and lymphedema.

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Detailed Description

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OBJECTIVES:

Primary

* To determine if expressive writing improves quality of life (QOL) relative to the control condition in breast cancer survivors with chronic stage II lymphedema.
* To determine if expressive writing improves physical and psychological symptoms/outcomes (i.e., fatigue, psychological distress, activity level, confidence in body) relative to the control condition in breast cancer survivors with chronic lymphedema.

Secondary

* To explore the influence of individual difference variables (dispositional optimism, emotional intelligence, and repressive coping) on outcomes associated with this intervention to include identification of subsets of individuals for whom expressive writing is most effective.
* To explore the influence of intrusive/avoidant thinking as a mediator between the intervention and outcomes of QOL and physical and psychological symptoms.

OUTLINE: Patients are randomized to 1 of 2 treatment groups.

Patients travel to the School of Nursing at Vanderbilt University or meet a team member in their home or another private location for an initial visit. Patients complete questionnaires, are measured for height and weight data, and arm fluid measurements.

* Expressive writing group: Twenty minutes a day, twice a week for 2 weeks, patients write about their deepest thoughts and feelings regarding their lymphedema and its treatment.
* Daily diary group (control): Twenty minutes a day, twice a week for 2 weeks patients write about how they manage their time .

Patients complete quality-of-life questionnaires periodically.

After completion of study, patients are followed at 1, 3, and 6 months.

Conditions

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Breast Cancer Fatigue Lymphedema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Experimental-EW

four emotion focused writing assignments

Group Type EXPERIMENTAL

expressive writing

Intervention Type BEHAVIORAL

four non-emotional writing assignments

control group

non-emotional writing control

Group Type ACTIVE_COMPARATOR

expressive writing

Intervention Type BEHAVIORAL

four non-emotional writing assignments

Interventions

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expressive writing

four non-emotional writing assignments

Intervention Type BEHAVIORAL

Other Intervention Names

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none noted

Eligibility Criteria

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Inclusion Criteria

* Able to read, write (for 20 minutes), and speak English
* Willing and able to drive to the study site or agree to be seen in an outpatient setting (e.g., private therapist office, outpatient clinic, physicians office, or own home) once

Exclusion Criteria

* Has medical condition that could cause edema, including any of the following:

* Symptomatic congestive heart failure
* Chronic/acute renal disease
* Cor pulmonale
* Nephrotic syndrome
* Nephrosis
* Liver failure
* Cirrhosis
* Pregnant or expect to become pregnant during course of the study
* Unable to stand upright for measurement of height and weight
* Has a metal implant, internal defibrillator, or pacemakers
* History of suicide attempts
* No recent suicidal ideation (within last 6 months)

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No concurrent intravenous chemotherapy or radiotherapy for active cancer
* No concurrent antipsychotic medication (i.e., haldol, thorazine, stelazine)

Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No