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

Not Applicable

Completed

• Conditions: Fatigue; Breast Cancer; Lymphedema
• Interventions: Behavioral: expressive writing

• Registration Number: NCT00679185
• Lead Sponsor: Vanderbilt University

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.

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2008-05-14
• Study First Submitted QC: 2008-05-14
• Study First Posted: 2008-05-16
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-07
• Last Update Posted: 2017-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 107

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental-EW	expressive writing	four emotion focused writing assignments
control group	expressive writing	non-emotional writing control

Primary Outcome Measures

Name	Time	Method
Quality of life	6 months
Fatigue	6 months
Psychological distress	6 months
Activity level	6 months
Physical and psychological symptoms	6 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Vanderbilt-Ingram Cancer Center at Franklin; 🇺🇸 Nashville, Tennessee, United States

Vanderbilt-Ingram Cancer Center; 🇺🇸 Nashville, Tennessee, United States

Vanderbilt-Ingram Cancer Center - Cool Springs; 🇺🇸 Nashville, Tennessee, United States