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Self-Care for Lymphedema in Patients With Breast Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00670644
First Posted: May 2, 2008
Last Update Posted: April 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sheila Ridner, Vanderbilt University
  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 Sheila Ridner, Vanderbilt University:

Primary Outcome Measures:
  • Identification and description of barriers to completing recommended at home self-care of lymphedema [ Time Frame: 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 ]
  • Identification of current at home self-care practices for lymphedema [ Time Frame: one time only for approximately 15 minutes ]

Secondary Outcome Measures:
  • 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 ]
  • Identification of patient-perceived benefits to at home self-care [ Time Frame: one time only for approximately 15 minutes ]

Enrollment: 51
Study Start Date: May 2006
Study Completion Date: March 2011
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: questionnaire administration
    Completed self-report form
    Other: survey administration
    Completed self-report form-other
    Procedure: quality-of-life assessment
    Completed self-report form qol
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
National Cancer Institute (NCI)
Investigators
Study Chair: Shiela H. Ridner, MSN, PhD, RN Vanderbilt-Ingram Cancer Center
  More Information

Responsible Party: Sheila Ridner, Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00670644     History of Changes
Other Study ID Numbers: CDR0000587714
P30CA068485 ( U.S. NIH Grant/Contract )
VU-VICC-SUPP-0628
VU-VICC-060480
First Submitted: May 1, 2008
First Posted: May 2, 2008
Last Update Posted: April 10, 2017
Last Verified: April 2017

Keywords provided by Sheila Ridner, 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
Breast Cancer Lymphedema
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Lymphatic Diseases
Postoperative Complications
Pathologic Processes