Trials / Completed
CompletedNCT00679185
Expressive Writing in Improving Quality of Life in Patients With Breast Cancer and Lymphedema
Effects of Expressive Writing in Breast Cancer Survivors With Lymphedema
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 107 (actual)
- Sponsor
- Vanderbilt University · Academic / Other
- Sex
- Female
- Age
- 21 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
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 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | expressive writing | four non-emotional writing assignments |
Timeline
- Start date
- 2007-01-01
- Primary completion
- 2011-01-01
- Completion
- 2011-01-01
- First posted
- 2008-05-16
- Last updated
- 2017-04-10
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00679185. Inclusion in this directory is not an endorsement.