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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 14, 2014