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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00679185
Recruitment Status : Completed
First Posted : May 16, 2008
Last Update Posted : April 10, 2017
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sheila Ridner, Vanderbilt University

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Fatigue Lymphedema Behavioral: expressive writing Not Applicable

Detailed Description:



  • 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.


  • 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 107 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effects of Expressive Writing in Breast Cancer Survivors With Lymphedema
Study Start Date : January 2007
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Experimental-EW
four emotion focused writing assignments
Behavioral: expressive writing
four non-emotional writing assignments
Other Name: none noted

Active Comparator: control group
non-emotional writing control
Behavioral: expressive writing
four non-emotional writing assignments
Other Name: none noted

Primary Outcome Measures :
  1. Physical and psychological symptoms [ Time Frame: 6 months ]
  2. Quality of life [ Time Frame: 6 months ]
  3. Fatigue [ Time Frame: 6 months ]
  4. Psychological distress [ Time Frame: 6 months ]
  5. Activity level [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Influence of intrusive/avoidant thinking in quality of life and physical or psychological symptoms [ Time Frame: baseline study entry ]
  2. Influence of individual difference variables to discover subsets for treatment effectiveness [ Time Frame: baseline study entry ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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


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)


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00679185

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United States, Tennessee
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, United States, 37064
Vanderbilt-Ingram Cancer Center at Franklin
Nashville, Tennessee, United States, 37064
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
Sponsors and Collaborators
Vanderbilt University
National Cancer Institute (NCI)
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Study Chair: Shiela H. Ridner, MSHSA, MSN, PhD, RN Vanderbilt-Ingram Cancer Center

Publications of Results:
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Responsible Party: Sheila Ridner, Associate Professor, Vanderbilt University Identifier: NCT00679185     History of Changes
Obsolete Identifiers: NCT00400049
Other Study ID Numbers: CDR0000587736
First Posted: May 16, 2008    Key Record Dates
Last Update Posted: April 10, 2017
Last Verified: April 2017

Keywords provided by Sheila Ridner, Vanderbilt University:
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Signs and Symptoms
Lymphatic Diseases