Self-Care for Lymphedema in Patients With Breast Cancer

Breast Cancer Clinical Trial

Official title:

Breast Cancer Treatment Related Lymphedema Self Care Practices

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00670644
• Other study ID #: CDR0000587714
• Secondary ID: P30CA068485VU-VI
• Status: Completed
• Phase: N/A
• First received: May 1, 2008
• Last updated: April 7, 2017
• Start date: May 2006
• Est. completion date: March 2011

Study information

• Verified date: April 2017
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: March 2011
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Lymphedema

Intervention

Other:
• questionnaire administration
Completed self-report form
• survey administration
Completed self-report form-other

Procedure:
• quality-of-life assessment
Completed self-report form qol

Locations

Country	Name	City	State
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee
United States	Vanderbilt-Ingram Cancer Center - Cool Springs	Nashville	Tennessee
United States	Vanderbilt-Ingram Cancer Center at Franklin	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification and description of barriers to completing recommended at home self-care of lymphedema		one time only for approximately 15 minutes
Primary	Identification of patients recalled instructions as to at home self-care practices for lymphedema as told to them by healthcare professionals and others		one time only for approximately 15 minutes
Primary	Identification of current at home self-care practices for lymphedema		one time only for approximately 15 minutes
Secondary	Relationship between at home self-care activities, symptoms, and quality of life in breast cancer survivors with lymphedema		one time only for approximately 15 minutes
Secondary	Identification of patient-perceived benefits to at home self-care		one time only for approximately 15 minutes