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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effects of Expressive Writing in Breast Cancer Survivors With Lymphedema

Conditions
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Breast Cancer, Fatigue, Lymphedema

Intervention / Treatment
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* Behavioral: expressive writing


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental-EW<br>four emotion focused writing assignments | Behavioral: expressive writing<br>* four non-emotional writing assignments<br>* Other names: none noted;|
| Active Comparator: control group<br>non-emotional writing control | Behavioral: expressive writing<br>* four non-emotional writing assignments<br>* Other names: none noted;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fatigue, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, lymphedema