Breast Cancer Clinical Trial
Official title:
Effects of Expressive Writing in Breast Cancer Survivors With Lymphedema
Verified date | April 2017 |
Source | Vanderbilt University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 107 |
Est. completion date | January 2011 |
Est. primary completion date | January 2011 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 21 Years to 80 Years |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
United States | Vanderbilt-Ingram Cancer Center | Nashville | Tennessee |
United States | Vanderbilt-Ingram Cancer Center - Cool Springs | Nashville | Tennessee |
United States | Vanderbilt-Ingram Cancer Center at Franklin | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt University | National Cancer Institute (NCI) |
United States,
Ridner SH, Bonner CM, Deng J, Sinclair VG. Voices from the shadows: living with lymphedema. Cancer Nurs. 2012 Jan-Feb;35(1):E18-26. doi: 10.1097/NCC.0b013e31821404c0. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Physical and psychological symptoms | 6 months | ||
Primary | Quality of life | 6 months | ||
Primary | Fatigue | 6 months | ||
Primary | Psychological distress | 6 months | ||
Primary | Activity level | 6 months | ||
Secondary | Influence of intrusive/avoidant thinking in quality of life and physical or psychological symptoms | baseline study entry | ||
Secondary | Influence of individual difference variables to discover subsets for treatment effectiveness | baseline study entry |
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