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Clinical Trials/NCT00679185
NCT00679185
Completed
Not Applicable

Effects of Expressive Writing in Breast Cancer Survivors With Lymphedema

Vanderbilt University3 sites in 1 country107 target enrollmentJanuary 2007

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Vanderbilt University
Enrollment
107
Locations
3
Primary Endpoint
Quality of life
Status
Completed
Last Updated
9 years ago

Overview

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 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.

Registry
clinicaltrials.gov
Start Date
January 2007
End Date
January 2011
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sheila Ridner

Associate Professor

Vanderbilt University

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Quality of life

Time Frame: 6 months

Fatigue

Time Frame: 6 months

Psychological distress

Time Frame: 6 months

Activity level

Time Frame: 6 months

Physical and psychological symptoms

Time Frame: 6 months

Secondary Outcomes

  • 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)

Study Sites (3)

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