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

May 14, 2008
June 20, 2012
January 2007
January 2011   (final data collection date for primary outcome measure)
  • 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 ]
  • Physical and psychological symptoms [ Designated as safety issue: No ]
  • Quality of life [ Designated as safety issue: No ]
  • Fatigue [ Designated as safety issue: No ]
  • Psychological distress [ Designated as safety issue: No ]
  • Activity level [ Designated as safety issue: No ]
  • Confidence in body [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00679185 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Influence of intrusive/avoidant thinking in quality of life and physical or psychological symptoms [ Designated as safety issue: No ]
  • Influence of individual difference variables to discover subsets for treatment effectiveness [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Expressive Writing in Improving Quality of Life in Patients With Breast Cancer and Lymphedema
Effects of Expressive Writing in Breast Cancer Survivors With Lymphedema

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Breast Cancer
  • Fatigue
  • Lymphedema
Behavioral: expressive writing
four non-emotional writing assignments
Other Name: none noted
  • Experimental: Experimental-EW
    four emotion focused writing assignments
    Intervention: Behavioral: expressive writing
  • Active Comparator: control group
    non-emotional writing control
    Intervention: Behavioral: expressive writing
Ridner SH, Bonner CM, Deng J, Sinclair VG. Voices from the shadows: living with lymphedema. Cancer Nurs. 2012 Jan-Feb;35(1):E18-26.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
107
January 2011
January 2011   (final data collection date for primary outcome measure)

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)
Female
21 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00679185
CDR0000587736, VU-VICC-SUPP-0422
Yes
Sheila H. Ridner, Vanderbilt University
Vanderbilt University
National Cancer Institute (NCI)
Study Chair: Shiela H. Ridner, MSHSA, MSN, PhD, RN Vanderbilt-Ingram Cancer Center
Vanderbilt University
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP