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Effects of Expressive Writing in Breast Cancer Survivors With Lymphedema

21 Years
80 Years
Not Enrolling
Breast Cancer, Fatigue, Lymphedema

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Trial Information

Effects of Expressive Writing in Breast Cancer Survivors With Lymphedema



- 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


- 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

- 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.

Inclusion Criteria


- 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)

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Physical and psychological symptoms

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Shiela H. Ridner, MSHSA, MSN, PhD, RN

Investigator Role:

Study Chair

Investigator Affiliation:

Vanderbilt-Ingram Cancer Center


United States: Federal Government

Study ID:




Start Date:

January 2007

Completion Date:

January 2011

Related Keywords:

  • Breast Cancer
  • Fatigue
  • Lymphedema
  • fatigue
  • stage I breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • lymphedema
  • Breast Neoplasms
  • Fatigue
  • Lymphedema



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