Clinical trial NCT00679185: Expressive Writing in Improving Quality of Life in Patients With Breast Cancer and Lymphedema
Official title: Effects of Expressive Writing in Breast Cancer Survivors With Lymphedema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Fatigue
Lymphedema
Keywords: fatigue
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
lymphedema
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-05-16
Enrollment: 107
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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)

Primary outcomes:
measure: Physical and psychological symptoms
timeFrame: 6 months
measure: Quality of life
timeFrame: 6 months
measure: Fatigue
timeFrame: 6 months
measure: Psychological distress
timeFrame: 6 months
measure: Activity level
timeFrame: 6 months
Secondary outcomes:
measure: Influence of intrusive/avoidant thinking in quality of life and physical or psychological symptoms
timeFrame: baseline study entry
measure: Influence of individual difference variables to discover subsets for treatment effectiveness
timeFrame: baseline study entry
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center - Cool Springs
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center at Franklin
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: Shiela H. Ridner, MSHSA, MSN, PhD, RN
role: STUDY_CHAIR
References:
citation: 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.