Status:
COMPLETED
Expressive Writing in Improving Quality of Life in Patients With Breast Cancer and Lymphedema
Lead Sponsor:
Vanderbilt University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Fatigue
Eligibility:
FEMALE
21-80 years
Phase:
NA
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
107 Patients enrolled
Trial Details
Trial ID
NCT00679185
Start Date
January 1 2007
End Date
January 1 2011
Last Update
April 10 2017
Active Locations (3)
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1
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, United States, 37064
2
Vanderbilt-Ingram Cancer Center at Franklin
Nashville, Tennessee, United States, 37064
3
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838