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

Breast Cancer Clinical Trial

Official title:

Effects of Expressive Writing in Breast Cancer Survivors With Lymphedema

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00679185
• Other study ID #: CDR0000587736
• Secondary ID: VU-VICC-SUPP-042
• Status: Completed
• Phase: N/A
• First received: May 14, 2008
• Last updated: April 7, 2017
• Start date: January 2007
• Est. completion date: January 2011

Study information

• Verified date: April 2017
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Other known NCT identifiers

• NCT00400049

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Fatigue
• Lymphedema

Intervention

Behavioral:
• expressive writing
four non-emotional writing assignments

Locations

Country	Name	City	State
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee
United States	Vanderbilt-Ingram Cancer Center - Cool Springs	Nashville	Tennessee
United States	Vanderbilt-Ingram Cancer Center at Franklin	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Ridner SH, Bonner CM, Deng J, Sinclair VG. Voices from the shadows: living with lymphedema. Cancer Nurs. 2012 Jan-Feb;35(1):E18-26. doi: 10.1097/NCC.0b013e31821404c0. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical and psychological symptoms		6 months
Primary	Quality of life		6 months
Primary	Fatigue		6 months
Primary	Psychological distress		6 months
Primary	Activity level		6 months
Secondary	Influence of intrusive/avoidant thinking in quality of life and physical or psychological symptoms		baseline study entry
Secondary	Influence of individual difference variables to discover subsets for treatment effectiveness		baseline study entry