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Clinical Trial 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.


Clinical Trial 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 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00679185
Study type Interventional
Source Vanderbilt University
Contact
Status Completed
Phase N/A
Start date January 2007
Completion date January 2011

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