- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00670644
Self-Care for Lymphedema in Patients With Breast Cancer
Breast Cancer Treatment Related Lymphedema Self Care Practices
RATIONALE: Identifying why patients don't do self care for lymphedema may help doctors plan better at-home self-care treatment.
PURPOSE: This research study is looking at self-care practices for lymphedema in patients with breast cancer.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
Primary
- To systematically identify and describe the barriers to completing recommended at home self-care of lymphedema in patients with breast cancer.
- To identify patient recalled instructions as to at home self-care practices for lymphedema as told to them by healthcare professionals and others.
- To identify the current at home self-care practices of breast cancer survivors with treatment treated lymphedema.
Secondary
- To examine the relationship between at home self-care activities and symptoms in breast cancer survivors with lymphedema.
- To examine the relationship between at home self-care activities and quality of life in breast cancer survivors with lymphedema.
- To identify patient-perceived benefits to at home self-care.
OUTLINE: Patients complete questionnaires about their breast cancer diagnosis and treatment history, lymphedema history and problems, and years of education and income. Patients also complete surveys about home self-care practices for lymphedema and any benefits, burdens, or barriers of at home care.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Tennessee
-
Nashville, Tennessee, United States, 37232-6838
- Vanderbilt-Ingram Cancer Center
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Nashville, Tennessee, United States, 37064
- Vanderbilt-Ingram Cancer Center - Cool Springs
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Nashville, Tennessee, United States, 37064
- Vanderbilt-Ingram Cancer Center at Franklin
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
DISEASE CHARACTERISTICS:
- History of breast cancer
- Lymphedema in one or both arms that occurred during or after breast cancer treatment
Must have received prior lymphedema treatment by a healthcare professional
- Patients with self-reported arm swelling subsequent to breast cancer treatment that has not been treated by a healthcare professional are not eligible
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Menopausal status not specified
- English speaking
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Identification and description of barriers to completing recommended at home self-care of lymphedema
Time Frame: one time only for approximately 15 minutes
|
one time only for approximately 15 minutes
|
Identification of patients recalled instructions as to at home self-care practices for lymphedema as told to them by healthcare professionals and others
Time Frame: one time only for approximately 15 minutes
|
one time only for approximately 15 minutes
|
Identification of current at home self-care practices for lymphedema
Time Frame: one time only for approximately 15 minutes
|
one time only for approximately 15 minutes
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Relationship between at home self-care activities, symptoms, and quality of life in breast cancer survivors with lymphedema
Time Frame: one time only for approximately 15 minutes
|
one time only for approximately 15 minutes
|
Identification of patient-perceived benefits to at home self-care
Time Frame: one time only for approximately 15 minutes
|
one time only for approximately 15 minutes
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Shiela H. Ridner, MSN, PhD, RN, Vanderbilt-Ingram Cancer Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000587714
- P30CA068485 (U.S. NIH Grant/Contract)
- VU-VICC-SUPP-0628
- VU-VICC-060480
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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