Clinical trial NCT00670644: Self-Care for Lymphedema in Patients With Breast Cancer
Official title: Breast Cancer Treatment Related Lymphedema Self Care Practices
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: male breast cancer
recurrent breast cancer
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
stage IV breast cancer
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-05-02
Enrollment: 51
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Breast Cancer patients

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Identification and description of barriers to completing recommended at home self-care of lymphedema
timeFrame: one time only for approximately 15 minutes
measure: Identification of patients recalled instructions as to at home self-care practices for lymphedema as told to them by healthcare professionals and others
timeFrame: one time only for approximately 15 minutes
measure: Identification of current at home self-care practices for lymphedema
timeFrame: one time only for approximately 15 minutes
Secondary outcomes:
measure: Relationship between at home self-care activities, symptoms, and quality of life in breast cancer survivors with lymphedema
timeFrame: one time only for approximately 15 minutes
measure: Identification of patient-perceived benefits to at home self-care
timeFrame: one time only for approximately 15 minutes
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, MSN, PhD, RN
role: STUDY_CHAIR
References: