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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Sheila H. Ridner, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00679185
First received: May 14, 2008
Last updated: June 20, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention
Breast Cancer
Fatigue
Lymphedema
Behavioral: expressive writing

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Effects of Expressive Writing in Breast Cancer Survivors With Lymphedema

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Physical and psychological symptoms [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Fatigue [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Psychological distress [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Activity level [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Influence of intrusive/avoidant thinking in quality of life and physical or psychological symptoms [ Time Frame: baseline study entry ] [ Designated as safety issue: No ]
  • Influence of individual difference variables to discover subsets for treatment effectiveness [ Time Frame: baseline study entry ] [ Designated as safety issue: No ]

Enrollment: 107
Study Start Date: January 2007
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental-EW
four emotion focused writing assignments
Behavioral: expressive writing
four non-emotional writing assignments
Other Name: none noted
Active Comparator: control group
non-emotional writing control
Behavioral: expressive writing
four non-emotional writing assignments
Other Name: none noted

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.

  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00679185

Locations
United States, Tennessee
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, United States, 37064
Vanderbilt-Ingram Cancer Center at Franklin
Nashville, Tennessee, United States, 37064
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
Sponsors and Collaborators
Vanderbilt University
Investigators
Study Chair: Shiela H. Ridner, MSHSA, MSN, PhD, RN Vanderbilt-Ingram Cancer Center
  More Information

Additional Information:
Publications:
Responsible Party: Sheila H. Ridner, Associate Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00679185     History of Changes
Obsolete Identifiers: NCT00400049
Other Study ID Numbers: CDR0000587736, VU-VICC-SUPP-0422
Study First Received: May 14, 2008
Last Updated: June 20, 2012
Health Authority: United States: Federal Government

Keywords provided by Vanderbilt University:
fatigue
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
lymphedema

Additional relevant MeSH terms:
Breast Neoplasms
Fatigue
Lymphedema
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Signs and Symptoms
Lymphatic Diseases

ClinicalTrials.gov processed this record on September 18, 2014