Self-Care for Lymphedema in Patients With Breast Cancer

April 7, 2017 updated by: Sheila Ridner, Vanderbilt University

Breast Cancer Treatment Related Lymphedema Self Care Practices

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

51

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232-6838
        • Vanderbilt-Ingram Cancer Center
      • Nashville, Tennessee, United States, 37064
        • Vanderbilt-Ingram Cancer Center - Cool Springs
      • Nashville, Tennessee, United States, 37064
        • Vanderbilt-Ingram Cancer Center at Franklin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Breast Cancer patients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Identification and description of barriers to completing recommended at home self-care of lymphedema
Time Frame: one time only for approximately 15 minutes
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
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
one time only for approximately 15 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
one time only for approximately 15 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Shiela H. Ridner, MSN, PhD, RN, Vanderbilt-Ingram Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

May 1, 2007

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

May 1, 2008

First Submitted That Met QC Criteria

May 1, 2008

First Posted (Estimate)

May 2, 2008

Study Record Updates

Last Update Posted (Actual)

April 10, 2017

Last Update Submitted That Met QC Criteria

April 7, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000587714
  • P30CA068485 (U.S. NIH Grant/Contract)
  • VU-VICC-SUPP-0628
  • VU-VICC-060480

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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