Self-Care for Lymphedema in Patients With Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00670644
First received: May 1, 2008
Last updated: March 16, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention
Breast Cancer
Other: questionnaire administration
Other: survey administration
Procedure: quality-of-life assessment

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Breast Cancer Treatment Related Lymphedema Self Care Practices

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Identification and description of barriers to completing recommended at home self-care of lymphedema [ Designated as safety issue: No ]
  • Identification of patients recalled instructions as to at home self-care practices for lymphedema as told to them by healthcare professionals and others [ Designated as safety issue: No ]
  • Identification of current at home self-care practices for lymphedema [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Relationship between at home self-care activities, symptoms, and quality of life in breast cancer survivors with lymphedema [ Designated as safety issue: No ]
  • Identification of patient-perceived benefits to at home self-care [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: May 2006
Study Completion Date: March 2011
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
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

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Breast Cancer patients

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00670644

Locations
United States, Tennessee
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, United States, 37064
Vanderbilt-Ingram Cancer Center at Franklin
Nashville, Tennessee, United States, 37064
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
Sponsors and Collaborators
Vanderbilt University
Investigators
Study Chair: Shiela H. Ridner, MSHSA, MSN, PhD, RN Vanderbilt-Ingram Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Sheila H. Ridner, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00670644     History of Changes
Other Study ID Numbers: CDR0000587714, P30CA68485, VU-VICC-SUPP-0628, VU-VICC-060480
Study First Received: May 1, 2008
Last Updated: March 16, 2011
Health Authority: United States: Federal Government

Keywords provided by Vanderbilt University:
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

Additional relevant MeSH terms:
Breast Neoplasms
Lymphedema
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Lymphatic Diseases

ClinicalTrials.gov processed this record on April 15, 2014