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

April 7, 2017 updated by: Sheila Ridner, Vanderbilt University

Effects of Expressive Writing in Breast Cancer Survivors With Lymphedema

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

107

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232-6838
        • Vanderbilt-Ingram Cancer Center
      • Nashville, Tennessee, United States, 37064
        • Vanderbilt-Ingram Cancer Center - Cool Springs
      • Nashville, Tennessee, United States, 37064
        • Vanderbilt-Ingram Cancer Center at Franklin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

DISEASE CHARACTERISTICS:

  • Women who have undergone prior surgery and/or radiotherapy for breast cancer

    • No metastatic disease

  • Must have lymphedema, meeting the following conditions:

    • Stage II disease

      • Swelling unrelieved by elevation, arm may be hard, may not pit with pressure, or skin changes have taken place
    • Received prior professional treatment for lymphedema
    • Requires life-long, at home self-care (e.g., compression sleeves)
  • No history of bilateral lymphedema prohibiting extracellular fluid comparison to an unaffected limb

PATIENT CHARACTERISTICS:

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental-EW
four emotion focused writing assignments
Behavioral: expressive writing
four non-emotional writing assignments
Other Names:
  • none noted
Active Comparator: control group
non-emotional writing control
Behavioral: expressive writing
four non-emotional writing assignments
Other Names:
  • none noted

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Quality of life
Time Frame: 6 months
6 months
Fatigue
Time Frame: 6 months
6 months
Physical and psychological symptoms
Time Frame: 6 months
6 months
Psychological distress
Time Frame: 6 months
6 months
Activity level
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Influence of intrusive/avoidant thinking in quality of life and physical or psychological symptoms
Time Frame: baseline study entry
baseline study entry
Influence of individual difference variables to discover subsets for treatment effectiveness
Time Frame: baseline study entry
baseline study entry

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Shiela H. Ridner, MSHSA, MSN, PhD, RN, Vanderbilt-Ingram Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

May 14, 2008

First Submitted That Met QC Criteria

May 14, 2008

First Posted (Estimate)

May 16, 2008

Study Record Updates

Last Update Posted (Actual)

April 10, 2017

Last Update Submitted That Met QC Criteria

April 7, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000587736
  • VU-VICC-SUPP-0422

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe