Expressive Writing in Improving Quality of Life in Patients With Breast Cancer and Lymphedema
Primary Purpose
Breast Cancer, Fatigue, Lymphedema
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
expressive writing
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer focused on measuring fatigue, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, lymphedema
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)
Sites / Locations
- Vanderbilt-Ingram Cancer Center - Cool Springs
- Vanderbilt-Ingram Cancer Center at Franklin
- Vanderbilt-Ingram Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental-EW
control group
Arm Description
four emotion focused writing assignments
non-emotional writing control
Outcomes
Primary Outcome Measures
Physical and psychological symptoms
Quality of life
Fatigue
Psychological distress
Activity level
Secondary Outcome Measures
Influence of intrusive/avoidant thinking in quality of life and physical or psychological symptoms
Influence of individual difference variables to discover subsets for treatment effectiveness
Full Information
NCT ID
NCT00679185
First Posted
May 14, 2008
Last Updated
April 7, 2017
Sponsor
Vanderbilt University
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00679185
Brief Title
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
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
107 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental-EW
Arm Type
Experimental
Arm Description
four emotion focused writing assignments
Arm Title
control group
Arm Type
Active Comparator
Arm Description
non-emotional writing control
Intervention Type
Behavioral
Intervention Name(s)
expressive writing
Other Intervention Name(s)
none noted
Intervention Description
four non-emotional writing assignments
Primary Outcome Measure Information:
Title
Physical and psychological symptoms
Time Frame
6 months
Title
Quality of life
Time Frame
6 months
Title
Fatigue
Time Frame
6 months
Title
Psychological distress
Time Frame
6 months
Title
Activity level
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Influence of intrusive/avoidant thinking in quality of life and physical or psychological symptoms
Time Frame
baseline study entry
Title
Influence of individual difference variables to discover subsets for treatment effectiveness
Time Frame
baseline study entry
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shiela H. Ridner, MSHSA, MSN, PhD, RN
Organizational Affiliation
Vanderbilt-Ingram Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Vanderbilt-Ingram Cancer Center - Cool Springs
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37064
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center at Franklin
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37064
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-6838
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21558848
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.
Results Reference
result
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Expressive Writing in Improving Quality of Life in Patients With Breast Cancer and Lymphedema
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